Histex Pd Liquid

Pronunciation: kar-bi-NOX-a-meen
Generic Name: Carbinoxamine Maleate
Brand Name: Examples include Histex Pd and Pediatex

Histex Pd Liquid is used for:

Treating allergy symptoms such as runny nose, watery/itchy eyes, rash, or hives. It may also be used for other conditions as determined by your doctor.

Histex Pd Liquid is an antihistamine. It works by blocking the action of histamine, which reduces the symptoms of an allergic reaction.

Do NOT use Histex Pd Liquid if:

• you are allergic to any ingredient in Histex Pd Liquid


• you are taking sodium oxybate (GHB) or a monoamine oxidase (MAO) inhibitor (eg, phenelzine)

Contact your doctor or health care provider right away if any of these apply to you.

Before using Histex Pd Liquid:

Some medical conditions may interact with Histex Pd Liquid. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have asthma, glaucoma, difficulty urinating, a stomach or bladder blockage, prostate problems, increased pressure in the eye, an underactive thyroid, heart disease, or high blood pressure

Some MEDICINES MAY INTERACT with Histex Pd Liquid. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Barbiturates (eg, phenobarbital), MAO inhibitors (eg, phenelzine ), or tricyclic antidepressants (eg, amitriptyline) because side effects of Histex Pd Liquid may be increased


• Sodium oxybate (GHB) because side effects, such as an increase in sleep duration and drowsiness leading to unconsciousness or coma, may occur

This may not be a complete list of all interactions that may occur. Ask your health care provider if Histex Pd Liquid may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Histex Pd Liquid:

Use Histex Pd Liquid as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Histex Pd Liquid may be taken with or without food.


• Use a measuring device marked for medicine dosing. Ask your pharmacist for help if you are unsure of how to measure your dose.


• If you miss a dose of Histex Pd Liquid and you are taking it regularly, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Histex Pd Liquid.

Important safety information:

• Histex Pd Liquid may cause drowsiness or dizziness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Histex Pd Liquid. Using Histex Pd Liquid alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.


• Use Histex Pd Liquid with caution in the ELDERLY because they may be more sensitive to its effects.


• Caution is advised when using Histex Pd Liquid in CHILDREN because they may be more sensitive to its effects.


• PREGNANCY and BREAST-FEEDING: It is unknown if Histex Pd Liquid can cause harm to the fetus. If you become pregnant while taking Histex Pd Liquid, discuss with your doctor the benefits and risks of using Histex Pd Liquid during pregnancy. It is unknown if Histex Pd Liquid is excreted in breast milk. If you are or will be breast-feeding while you are using Histex Pd Liquid, check with your doctor or pharmacist to discuss the risks to your baby.

Possible side effects of Histex Pd Liquid:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Appetite loss; blurred vision; diarrhea; dizziness; drowsiness; dry mouth, nose, or throat; headache; heartburn; nausea; nervousness; thickening of mucus in the nose or throat; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue).

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Histex Pd side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include double vision; excitement; frequent urination; hallucinations; loss of consciousness; muscle twitching; seizures; tremor; weakness. In children, symptoms may include abnormal eye movement; abnormal tongue movement; agitation; bizarre behavior; confusion; difficulty urinating; excitation; flushed face; irritability; loss of consciousness; loss of coordination; restlessness; seizures; slurred speech; tiredness; trembling; twitching.

Proper storage of Histex Pd Liquid:

Store Histex Pd Liquid between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Histex Pd Liquid out of the reach of children and away from pets.

General information:

• If you have any questions about Histex Pd Liquid, please talk with your doctor, pharmacist, or other health care provider.


• Histex Pd Liquid is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Histex Pd Liquid. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Histex Pd resources

• Histex Pd Side Effects (in more detail)
• Histex Pd Use in Pregnancy & Breastfeeding
• Histex Pd Drug Interactions
• 0 Reviews for Histex Pd - Add your own review/rating

Compare Histex Pd with other medications

• Allergic Reactions
• Allergic Urticaria
• Conjunctivitis, Allergic
• Dermatographism
• Hay Fever
• Vasomotor Rhinitis

hydrocodone and ibuprofen

Generic Name: hydrocodone and ibuprofen (hye dro KOE done and eye byoo PRO fen)

Brand Names: Ibudone, Reprexain, Vicoprofen

What is hydrocodone and ibuprofen?

Hydrocodone is in a group of drugs called narcotic pain relievers.

Ibuprofen is in a group of drugs called nonsteroidal anti-inflammatory drugs (NSAIDs). Ibuprofen works by reducing hormones that cause inflammation and pain in the body.

The combination of hydrocodone and ibuprofen is used short-term to relieve severe pain. This medication is not for treating arthritis pain.

Hydrocodone and ibuprofen may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about hydrocodone and ibuprofen?

Ibuprofen can increase your risk of heart attack or stroke. Do not use this medicine just before or after having heart bypass surgery (also called coronary artery bypass graft, or CABG). Seek emergency medical help if you have chest pain, weakness, shortness of breath, slurred speech, or problems with vision or balance.

Ibuprofen can also increase your risk of serious effects on the stomach or intestines. These conditions can be fatal and can occur without warning at any time while you are taking ibuprofen. Call your doctor at once if you have black, bloody, or tarry stools, or if you cough up blood or vomit that looks like coffee grounds.

Hydrocodone may be habit-forming and should be used only by the person this medicine was prescribed for. Keep the medication in a secure place where others cannot get to it. Avoid drinking alcohol while taking hydrocodone and ibuprofen. Alcohol may increase your risk of stomach bleeding while taking ibuprofen.

Tell your doctor if the medicine seems to stop working as well in relieving your pain.

What should I discuss with my healthcare provider before taking hydrocodone and ibuprofen?

Do not use this medication if you are allergic to hydrocodone or ibuprofen (Advil, Motrin). Hydrocodone may be habit-forming and should be used only by the person this medicine was prescribed for. This medication should never be shared with another person, especially someone who has a history of drug abuse or addiction. Keep the medication in a secure place where others cannot get to it.

Taking ibuprofen can increase your risk of life-threatening heart or circulation problems, including heart attack or stroke. Do not use this medicine just before or after having heart bypass surgery (also called coronary artery bypass graft, or CABG).

Ibuprofen can also increase your risk of serious effects on the stomach or intestines, including bleeding or perforation (forming of a hole). These conditions can be fatal and can occur without warning at any time while you are taking ibuprofen.

Do not use this medication if you are allergic to ibuprofen (Advil, Motrin) or other NSAIDs such as Aleve, Orudis, Indocin, Lodine, Voltaren, Toradol, Mobic, Relafen, Feldene, and others.

Before using hydrocodone and ibuprofen, tell your doctor if you have:

• 
  

  heart disease, congestive heart failure, high blood pressure, or a history of heart attack, stroke, or blood clot;

  
  


• 
  

  asthma or other breathing disorders;

  
  


• liver or kidney disease;


• 
  

  a history of head injury or brain tumor;

  
  


• 
  

  stomach or intestinal disorder, history of stomach ulcer or bleeding;

  
  


• 
  

  underactive thyroid, Addison's disease or other adrenal gland disorder;

  
  


• 
  

  curvature of the spine;

  
  


• 
  

  an enlarged prostate or problems with urination; or

  
  


• 
  

  mental illness or a history of drug or alcohol addiction.

  
  

If you have any of these conditions, you may not be able to use hydrocodone and ibuprofen, or you may need a dosage adjustment or special tests during treatment.

FDA pregnancy category C. This medication may be harmful to an unborn baby, and could cause breathing problems or addiction/withdrawal symptoms in a newborn. Taking ibuprofen during the last 3 months of pregnancy may harm the unborn baby. Do not take hydrocodone and ibuprofen during pregnancy unless your doctor has told you to. Hydrocodone and ibuprofen may pass into breast milk and could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Older adults may be more sensitive to the effects of this medicine.

How should I take hydrocodone and ibuprofen?

Take this medication exactly as it was prescribed for you. Do not take it in larger amounts, or use it for longer than recommended by your doctor. Follow the directions on your prescription label. Tell your doctor if the medicine seems to stop working as well in relieving your pain.

Drink 6 to 8 full glasses of water daily to help prevent constipation while you are taking hydrocodone and ibuprofen. Ask your doctor about ways to increase the fiber in your diet. Do not use a stool softener (laxative) without first asking your doctor.

If you need to have any type of surgery, tell the surgeon ahead of time that you are using hydrocodone and ibuprofen.

Store hydrocodone and ibuprofen at room temperature away from moisture and heat.

Keep track of how many tablets have been used from each new bottle of this medicine. Hydrocodone is a drug of abuse and you should be aware if any person in the household is using this medicine improperly or without a prescription.

See also: Hydrocodone and ibuprofen dosage (in more detail)

What happens if I miss a dose?

Since hydrocodone and ibuprofen is taken as needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and wait until your next regularly scheduled dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine. An overdose of hydrocodone and ibuprofen can be fatal.

Overdose symptoms may include extreme drowsiness, nausea, vomiting, dark urine, jaundice (yellowing of the skin or eyes), black or bloody stools, coughing up blood, urinating less than usual or not at all, confusion, ringing in your ears, pinpoint pupils, weak pulse, slow heart rate, blue lips, shallow breathing, or fainting.

What should I avoid while taking hydrocodone and ibuprofen?

This medication can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert. Do not use any other over-the-counter cold, allergy, or pain medication without first asking your doctor or pharmacist. Many medicines available over the counter contain ibuprofen or similar medicines. Read the label of any other medicine you are using to see if it contains ibuprofen, ketoprofen, or naproxen. Avoid drinking alcohol while taking hydrocodone and ibuprofen. Alcohol can increase your risk of stomach bleeding caused by ibuprofen. Tell your doctor if you regularly use other medicines that make you sleepy (such as cold or allergy medicine, other narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety). They can add to sleepiness caused by hydrocodone.

Hydrocodone and ibuprofen side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have any of these serious side effects:

• 
  

  chest pain, weakness, shortness of breath, slurred speech, problems with vision or balance;

  
  


• 
  

  sudden numbness or weakness, headache, confusion, or problems with vision, speech, or balance;

  
  


• 
  

  black, bloody, or tarry stools, coughing up blood or vomit that looks like coffee grounds;

  
  


• 
  

  swelling or rapid weight gain;

  
  


• 
  

  shallow breathing, slow heartbeat;

  
  


• 
  

  confusion, feeling light-headed, fainting;

  
  


• 
  

  easy bruising or bleeding;

  
  


• 
  

  nausea, stomach pain, loss of appetite, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

  
  


• 
  

  severe blistering, peeling, and red skin rash; or

  
  


• 
  

  fever, headache, neck stiffness, chills, increased sensitivity to light, purple spots on the skin, and/or seizure (convulsions).

  
  

Less serious side effects may include:

• 
  

  headache, dizziness, drowsiness;

  
  


• 
  

  mild nausea, vomiting, upset stomach, constipation, diarrhea;

  
  


• 
  

  blurred vision; or

  
  


• 
  

  dry mouth.

  
  

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

Hydrocodone and ibuprofen Dosing Information

Usual Adult Dose for Pain:

For short-term (generally less than 10 days) management of acute pain:
1 tablet every 4 to 6 hours as needed

Maximum dosage: 5 tablets in 24 hours

What other drugs will affect hydrocodone and ibuprofen?

Before taking this medication, tell your doctor if you are using any of the following drugs:

• 
  

  antidepressants such as amitriptyline (Elavil, Etrafon) or imipramine (Janimine, Tofranil);

  
  


• 
  

  an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate);

  
  


• 
  

  aspirin or other NSAIDs (non-steroidal anti-inflammatory drugs) such as diclofenac (Voltaren), etodolac (Lodine), indomethacin (Indocin), naproxen (Aleve, Naprosyn), and others;

  
  


• 
  

  an ACE inhibitor such as benazepril (Lotensin), captopril (Capoten), fosinopril (Monopril), enalapril (Vasotec), lisinopril (Prinivil, Zestril), quinapril (Accupril), and others;

  
  


• 
  

  lithium (Eskalith, Lithobid);

  
  


• 
  

  a bronchodilator (such as Atrovent, Spiriva), diuretics (water pills), steroid medicines, or blood thinners;

  
  


• 
  

  methotrexate (Rheumatrex, Trexall);

  
  


• 
  

  an injected narcotic medication such as pentazocine (Talwin), butorphanol (Stadol), or nalbuphine Nubain);

  
  


• 
  

  atropine (Donnatal), dimenhydrinate (Dramamine), or scopolamine (Transderm-Scop); or

  
  


• 
  

  bowel or bladder medications such as dicyclomine (Bentyl), hyoscyamine (Anaspaz, Cystospaz, Levsin), tolterodine (Detrol) and others.

  
  

This list is not complete and there may be other drugs that can interact with hydrocodone and ibuprofen. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

More hydrocodone and ibuprofen resources

• Hydrocodone and ibuprofen Side Effects (in more detail)
• Hydrocodone and ibuprofen Dosage
• Hydrocodone and ibuprofen Use in Pregnancy & Breastfeeding
• Drug Images
• Hydrocodone and ibuprofen Drug Interactions
• Hydrocodone and ibuprofen Support Group
• 42 Reviews for Hydrocodone and ibuprofen - Add your own review/rating

Compare hydrocodone and ibuprofen with other medications

• Pain

Where can I get more information?

• Your pharmacist can provide more information about hydrocodone and ibuprofen.

See also: hydrocodone and ibuprofen side effects (in more detail)

Humate-P

Pronunciation: AN-tee-hee-moe-FIL-ik FAK-tor/von WILL-a-brand FAK-tor
Generic Name: Antihemophilic Factor/von Willebrand Factor (Human)
Brand Name: Humate-P

Humate-P is used for:

Preventing and controlling bleeding in adult patients with hemophilia A. It is also used to control certain types of bleeding episodes (eg, due to injury or surgery) in patients with von Willebrand disease.

Humate-P is a human clotting factor complex prepared from pooled human plasma. It works by increasing the amount of clotting factor VIII and von Willebrand factor in the blood. This helps the blood to clot properly, which helps to stop bleeding.

Do NOT use Humate-P if:

• you are allergic to any ingredient in Humate-P


• you have had a severe allergic reaction to other medicines that contain antihemophilic factor or von Willebrand factor

Contact your doctor or health care provider right away if any of these apply to you.

Before using Humate-P:

Some medical conditions may interact with Humate-P. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have a history of blood clots in the legs, lungs, or eye, or if you are at risk for developing blood clots

Some MEDICINES MAY INTERACT with Humate-P. However, no specific interactions with Humate-P are known at this time.

Ask your health care provider if Humate-P may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Humate-P:

Use Humate-P as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Humate-P may be given as an injection at your doctor's office, hospital, or clinic. If you will be using Humate-P at home, a health care provider will teach you how to use it. Be sure you understand how to use Humate-P. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.


• Do not shake Humate-P.


• Do not use Humate-P if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.


• Use Humate-P within 3 hours after mixing.


• Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.


• If you miss a dose of Humate-P, contact your doctor right away.

Ask your health care provider any questions you may have about how to use Humate-P.

Important safety information:

• Humate-P comes from human blood. Rarely, patients receiving products that come from human blood have developed certain viral infections (eg, parvovirus B19, hepatitis A). Discuss any questions or concerns with your doctor. Contact your doctor if you develop symptoms such as fever, rash, joint aches or pain, loss of appetite, nausea, vomiting, unusual tiredness, or yellowing of the eyes or skin.


• Discuss with your doctor whether you should receive a hepatitis A and hepatitis B vaccine.


• Patients receiving products that come from human blood have a very rare risk of developing a central nervous system disease called Creutzfeldt-Jakob disease. Discuss any questions or concerns with your doctor.


• Tell your doctor or dentist that you take Humate-P before you receive any medical or dental care, emergency care, or surgery. Blood clotting tests will be performed if you have surgery.


• Lab tests, including blood clotting tests, blood hematocrit levels, factor VIII levels, or von Willebrand factor levels, may be performed while you use Humate-P. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


• Humate-P should be used with extreme caution in NEWBORNS; safety and effectiveness in newborns have not been confirmed.


• PREGNANCY and BREAST-FEEDING: It is not known if Humate-P can cause harm to the fetus. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Humate-P while you are pregnant. It is not known if Humate-P is found in breast milk. If you are or will be breast-feeding while you use Humate-P, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Humate-P:

All medicines may cause side effects, but many people have no, or minor side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Mild numbness or tingling.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); back or stomach pain; calf pain, swelling, or tenderness; chest pain; coughing up blood; dark urine; fever or chills; new or worsening bruising or bleeding; shortness of breath; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Humate-P side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Humate-P:

Store Humate-P in the refrigerator or at room temperature up to 77 degrees. Store away from heat and light. Do not freeze. Do not refrigerate after mixing. Do not use Humate-P past the expiration date on the container. Keep Humate-P out of the reach of children and away from pets.

General information:

• If you have any questions about Humate-P, please talk with your doctor, pharmacist, or other health care provider.


• Humate-P is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Humate-P. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Humate-P resources

• Humate-P Side Effects (in more detail)
• Humate-P Use in Pregnancy & Breastfeeding
• Humate-P Support Group
• 1 Review for Humate-P - Add your own review/rating

• Humate-P Prescribing Information (FDA)


• Humate-P Advanced Consumer (Micromedex) - Includes Dosage Information


• Alphanate Prescribing Information (FDA)


• Wilate Consumer Overview

Compare Humate-P with other medications

• Hemophilia A
• von Willebrand's Disease

Risperidona Generis

Risperidona Generis may be available in the countries listed below.

Ingredient matches for Risperidona Generis

Risperidone

Risperidone is reported as an ingredient of Risperidona Generis in the following countries:

• Portugal

International Drug Name Search

Insulidd-N

Insulidd-N may be available in the countries listed below.

Ingredient matches for Insulidd-N

Insulin, Isophane

Insulin, Isophane human (a derivative of Insulin, Isophane) is reported as an ingredient of Insulidd-N in the following countries:

• Myanmar

International Drug Name Search

Hyflex-DS

Generic Name: acetaminophen and phenyltoloxamine (a seet a MIN oh fen and FEN il toe LOX a meen)

Brand Names: Aceta-Gesic, Acuflex, Alpain, Apagesic, BeFlex, BP Poly-650, Dologesic, Flextra-650, Flextra-DS, Hyflex-650, Hyflex-DS, Lagesic, Major-gesic, Percogesic, Phenagesic, Phenylgesic, Q Flex, Relagesic, RhinoFlex, RhinoFlex 650, Staflex, Vistra, Vitoxapap, Zgesic

What is Hyflex-DS (acetaminophen and phenyltoloxamine)?

Acetaminophen is a pain reliever and a fever reducer.

Phenyltoloxamine is an antihistamine that reduces the effects of natural chemical histamine in the body. Histamine can produce symptoms of sneezing, itching, watery eyes, and runny nose.

Acetaminophen and phenyltoloxamine is used to treat runny nose, sneezing, and pain or fever caused by the common cold, flu, or seasonal allergies.

Acetaminophen and phenyltoloxamine may also be used for purposes not listed in this medication guide.

What is the most important information I should know about Hyflex-DS (acetaminophen and phenyltoloxamine)?

Do not take this medication without a doctor's advice if you have ever had alcoholic liver disease (cirrhosis) or if you drink more than 3 alcoholic beverages per day. You may not be able to take medicine that contains acetaminophen. Do not use cold medicine if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects.

Ask a doctor or pharmacist if it is safe for you to take this medicine if you have liver or kidney disease, diabetes, glaucoma, urination problems, an enlarged prostate, heart disease, high blood pressure, a stomach ulcer, or an overactive thyroid.

Do not take more of this medication than is recommended. An overdose of acetaminophen can damage your liver or cause death. Avoid drinking alcohol. It may increase your risk of liver damage while taking acetaminophen. Ask a doctor or pharmacist before using any other cold, allergy, pain, or sleep medication. Acetaminophen (sometimes abbreviated as APAP) is contained in many combination medicines. Taking certain products together can cause you to get too much acetaminophen which can lead to a fatal overdose. Check the label to see if a medicine contains acetaminophen or APAP.

What should I discuss with my healthcare provider before taking Hyflex-DS (acetaminophen and phenyltoloxamine)?

You should not take this medication if you are allergic to acetaminophen or phenyltoloxamine. Do not take this medication without a doctor's advice if you have ever had alcoholic liver disease (cirrhosis) or if you drink more than 3 alcoholic beverages per day. You may not be able to take medicine that contains acetaminophen. Do not use acetaminophen and phenyltoloxamine if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects.

Ask a doctor or pharmacist if it is safe for you to take this medicine if you have:

• liver disease or a history of alcoholism;


• 
  

  kidney disease;

  
  


• 
  

  diabetes;

  
  


• 
  

  glaucoma;

  
  


• 
  

  urination problems;

  
  


• 
  

  an enlarged prostate;

  
  


• 
  

  heart disease or high blood pressure;

  
  


• 
  

  a stomach ulcer; or

  
  


• 
  

  an overactive thyroid.

  
  

It is not known whether acetaminophen and phenyltoloxamine is harmful to an unborn baby. Do not take this medication without telling your doctor if you are pregnant. Acetaminophen and phenyltoloxamine can pass into breast milk and may harm a nursing baby. Do not take this medication without telling your doctor if you are breast-feeding a baby.

How should I take Hyflex-DS (acetaminophen and phenyltoloxamine)?

Use exactly as directed on the label, or as prescribed by your doctor. Do not take more of this medication than is recommended. An overdose of acetaminophen can damage your liver or cause death. Cold or allergy medicine is usually taken only for a short time until your symptoms clear up.

One tablet of this medicine may contain up to 650 mg of acetaminophen. Know the amount of acetaminophen in the specific product you are taking.

Do not give this medication to a child younger than 4 years old. Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children. Do not crush, chew, or break an extended-release tablet. Swallow it whole. Breaking the pill may cause too much of the drug to be released at one time.

Call your doctor if your symptoms do not improve, or if you have a fever for longer than 3 days.

This medication can cause unusual results with allergy skin tests. Tell any doctor who treats you that you are taking an antihistamine.

Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Since cold or allergy medicine is taken when needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of acetaminophen can be fatal.

The first signs of an acetaminophen overdose include loss of appetite, nausea, vomiting, stomach pain, sweating, and confusion or weakness. Later symptoms may include pain in your upper stomach, dark urine, and yellowing of your skin or the whites of your eyes.

Overdose symptoms may also include feeling very restless, extreme drowsiness, warmth or tingly feeling, or seizure (convulsions).

What should I avoid while taking Hyflex-DS (acetaminophen and phenyltoloxamine)?

This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Avoid drinking alcohol. It may increase your risk of liver damage while taking acetaminophen. Ask a doctor or pharmacist before using any other cold, allergy, pain, or sleep medication. Acetaminophen (sometimes abbreviated as APAP) is contained in many combination medicines. Taking certain products together can cause you to get too much acetaminophen which can lead to a fatal overdose. Check the label to see if a medicine contains acetaminophen or APAP. Avoid becoming overheated or dehydrated during exercise and in hot weather. Phenyltoloxamine can decrease sweating and you may be more prone to heat stroke.

Hyflex-DS (acetaminophen and phenyltoloxamine) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using this medication and call your doctor at once if you have a serious side effect such as:

• 
  

  fast, pounding, or uneven heartbeat;

  
  


• 
  

  confusion, hallucinations, unusual thoughts or behavior;

  
  


• 
  

  severe dizziness, anxiety, restless feeling, nervousness;

  
  


• 
  

  urinating less than usual or not at all;

  
  


• 
  

  nausea, pain in your upper stomach, itching, loss of appetite, dark urine, clay colored stools, jaundice (yellowing of the skin or eyes); or

  
  


• 
  

  easy bruising or bleeding, unusual weakness, fever, chills, body aches, flu symptoms.

  
  

Less serious side effects may include:

• 
  

  dizziness, drowsiness;

  
  


• 
  

  blurred vision;

  
  


• 
  

  dry mouth, nose, or throat;

  
  


• 
  

  mild stomach pain, constipation; or

  
  


• 
  

  problems with memory or concentration.

  
  

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Hyflex-DS (acetaminophen and phenyltoloxamine)?

Before using this medicine, tell your doctor if you regularly use other medicines that make you sleepy (such as other cold or allergy medicine, sedatives, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety). They can add to sleepiness caused by phenyltoloxamine.

There may be other drugs that can interact with acetaminophen and phenyltoloxamine. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More Hyflex-DS resources

• Hyflex-DS Side Effects (in more detail)
• Hyflex-DS Use in Pregnancy & Breastfeeding
• Hyflex-DS Drug Interactions
• Hyflex-DS Support Group
• 0 Reviews for Hyflex-DS - Add your own review/rating

• Acuflex MedFacts Consumer Leaflet (Wolters Kluwer)


• Acuflex Consumer Overview


• Lagesic Controlled-Release Tablets MedFacts Consumer Leaflet (Wolters Kluwer)


• Percogesic Consumer Overview

Compare Hyflex-DS with other medications

• Cold Symptoms
• Headache
• Influenza
• Pain

Where can I get more information?

• Your pharmacist can provide more information about acetaminophen and phenyltoloxamine.

See also: Hyflex-DS side effects (in more detail)

Hydrocortisone and Acetic Acid

Hydrocortisone 1%

and Acetic Acid 2%

Otic Solution

(Hydrocortisone and Acetic Acid Otic Solution, USP)

Rx only

Hydrocortisone and Acetic Acid Description

Hydrocortisone and Acetic Acid Otic Solution, USP contains Hydrocortisone (1%) and acetic acid, glacial (2%) in a propylene glycol vehicle containing propylene glycol diacetate (3%) and benzethonium chloride (0.02%), sodium acetate (0.015%) and citric acid (0.2%).

Acetic acid has a molecular formula of CH3COOH with molecular weight of 60.05. The structural formula is:

Acetic Acid

Hydrocortisone is a Synthetic Steroid used as an anti-inflammatory and antipruritic agent. Its chemical name is Pregn-4-ene-3,20-dione, 11, 17, 21-trihydroxy-, (11β)-. Hydrocortisone has a molecular formula of C21H30O5 with molecular weight 362.46. The structural formula is:

Hydrocortisone

Hydrocortisone and Acetic Acid is available as a non-aqueous otic solution buffered at pH (2.0 to 4.0) for use in the external ear canal.

Hydrocortisone and Acetic Acid - Clinical Pharmacology

Acetic acid is anti-bacterial and antifungal; hydrocortisone is anti-inflammatory, antiallergic and antipruritic; propylene glycol is hydrophilic and provides a low surface tension; benzethonium chloride is a surface active agent that promotes contact of the solution with tissues.

Indications and Usage for Hydrocortisone and Acetic Acid

For the treatment of superficial infections of the external auditory canal caused by organisms susceptible to the action of the antimicrobial, complicated by inflammation.

Contraindications

Hypersensitivity to Hydrocortisone and Acetic Acid otic solution or any of the ingredients; herpes simplex, vaccinia and varicella. Perforated tympanic membrane is considered a contraindication to the use of any medication in the external ear canal.

Warnings

Discontinue promptly if sensitization or irritation occurs.

Precautions

Transient stinging or burning may be noted occasionally when the solution is first instilled into the acutely inflamed ear.

Pediatric Use

Safety and effectiveness in pediatric patients below the age of 3 years have not been established.

Adverse Reactions

Stinging or burning may be noted occasionally; local irritation has occurred very rarely.

Hydrocortisone and Acetic Acid Dosage and Administration

Carefully remove all cerumen and debris to allow hydrocortisone 1% and acetic acid 2% otic solution to contact infected surfaces directly. To promote continuous contact, insert a wick of cotton saturated with the solution into the ear canal; the wick may also be saturated after insertion. Instruct the patient to keep the wick in for at least 24 hours and to keep it moist by adding 3 to 5 drops of the solution every 4 to 6 hours. The wick may be removed after 24 hours but the patient should continue to instill 5 drops 3 or 4 times daily thereafter, for as long as indicated. In pediatric patients, 3 to 4 drops may be sufficient due to the smaller capacity of the ear canal.

How is Hydrocortisone and Acetic Acid Supplied

Hydrocortisone 1% and acetic acid 2% otic solution is available in 10 mL plastic, controlled dropper tip bottle.

 

10 mL bottle NDC 51672-3007-1

Store at 15°- 30°C (59°- 86°F) [see USP Controlled Room Temperature]. Protect from freezing. Keep container tightly closed.

Mfd. by: Taro Pharmaceuticals Inc.

Brampton, Ontario, Canada L6T 1C1

Dist. by: Taro Pharmaceuticals U.S.A., Inc.

Hawthorne, NY 10532

Issued: June 2004

PK-4785-0 149

PRINCIPAL DISPLAY PANEL - 10 mL Carton

10 mL

NDC 51672-3007-1

Hydrocortisone 1%

and Acetic Acid 2%

Otic Solution USP

FOR OTIC USE ONLY.

Keep this and all

medications out of the

reach of children.

Rx only

TARO

Hydrocortisone and Acetic Acid  Hydrocortisone and Acetic Acid  solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 51672-3007 Route of Administration AURICULAR (OTIC) DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Hydrocortisone (Hydrocortisone) Hydrocortisone 10.4 mg  in 1 mL Acetic Acid (Acetic Acid) Acetic Acid 20.8 mg  in 1 mL

Inactive Ingredients Ingredient Name Strength propylene glycol   propylene glycol diacetate   benzethonium chloride   sodium acetate   anhydrous citric acid

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 51672-3007-1 1 BOTTLE In 1 CARTON contains a BOTTLE 1 10 mL In 1 BOTTLE This package is contained within the CARTON (51672-3007-1)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA088759	04/28/2005

Labeler - Taro Pharmaceuticals U.S.A., Inc. (145186370)

Establishment
Name	Address	ID/FEI	Operations
Taro Pharmaceuticals Inc.		206263295	MANUFACTURE

Revised: 08/2011Taro Pharmaceuticals U.S.A., Inc.

More Hydrocortisone and Acetic Acid resources

• Hydrocortisone and Acetic Acid Side Effects (in more detail)
• Hydrocortisone and Acetic Acid Use in Pregnancy & Breastfeeding
• Hydrocortisone and Acetic Acid Support Group
• 1 Review for Hydrocortisone and Acetic Acid - Add your own review/rating

Compare Hydrocortisone and Acetic Acid with other medications

• Otitis Externa