Tussionex

DRUG DESCRIPTION

Each teaspoonful (5 mL) of TUSSIONEX (hydrocodone and chlorpheniramine) Pennkinetic Extended-Release Suspension contains hydrocodone polistirex equivalent to 10 mg of hydrocodone bitartrate and chlorpheniramine polistirex equivalent to 8 mg of chlorpheniramine maleate. TUSSIONEX (hydrocodone and chlorpheniramine) Pennkinetic Extended- Release Suspension provides up to 12-hour relief per dose. Hydrocodone is a centrally-acting narcotic antitussive. Chlorpheniramine is an antihistamine. TUSSIONEX (hydrocodone and chlorpheniramine) Pennkinetic Extended- Release Suspension is for oral use only.

Hydrocodone Polistirex

Sulfonated styrene-divinylbenzene copolymer complex with 4,5?-epoxy-3-methoxy-17- methylmorphinan-6-one.

Hydrocodone polistirex structural formula illustration

Chlorpheniramine Polistirex

Sulfonated styrene-divinylbenzene copolymer complex with 2-[p-chloro-?-[2- (dimethylamino)ethyl]-benzyl]pyridine.

Chlorpheniramine Polistirex structural formula illustration

Inactive Ingredients

Ascorbic acid, D&C Yellow No. 10, ethylcellulose, FD&C Yellow No. 6, flavor, high fructose corn syrup, methylparaben, polyethylene glycol 3350, polysorbate 80, pregelatinized starch, propylene glycol, propylparaben, purified water, sucrose, vegetable oil, xanthan gum.

What are the possible side effects of chlorpheniramine and hydrocodone (HyTan, Novasus, S-T Forte 2, TussiCaps, Tussionex PennKinetic)?

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:

  • weak or shallow breathing;
  • chest tightness;
  • painful urination;
  • urinating less than usual or not at all; or
  • confusion, hallucinations, or unusual behavior.

Less...

Read All Potential Side Effects and See Pictures of Tussionex

What are the precautions when taking hydrocodone and chlorpheniramine (Tussionex)?

Before taking this product, tell your doctor or pharmacist if you are allergic to hydrocodone or chlorpheniramine; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: breathing problems (such as asthma, croup), certain brain disorders (such as seizures, head injury, tumor, increased intracranial pressure), stomach/intestinal problems ( such as blockage, ileus, chronic constipation, Clostridium difficile-associated diarrhea), glaucoma (narrow-angle), difficulty urinating (such as due to enlarged prostate or urethral stricture), personal or family history of...

Read All Potential Precautions of Tussionex


Tussionex Consumer (continued)

SIDE EFFECTS: Drowsiness, dizziness, nausea/vomiting, constipation, blurred vision, dry mouth/nose/throat may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

To relieve dry mouth, suck (sugarless) hard candy or ice chips, chew (sugarless) gum, drink water, or use a saliva substitute. This medication can dry up and thicken mucus in your lungs, making it more difficult to breathe and clear your lungs. To help prevent this effect, drink plenty of fluids unless otherwise directed by your doctor.

To prevent constipation, eat a diet adequate in fiber, drink plenty of water, and exercise. If you become constipated while using this drug, consult your pharmacist for help in selecting a laxative (such as stimulant-type with stool softener).

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: slow/shallow breathing, mental/mood changes (such as depression, agitation), trouble urinating.

Tell your doctor immediately if any of these rare but serious side effects occur: seizures, fast/slow/irregular heartbeat.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking this product, tell your doctor or pharmacist if you are allergic to hydrocodone or chlorpheniramine; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: breathing problems (such as asthma, croup), certain brain disorders (such as seizures, head injury, tumor, increased intracranial pressure), stomach/intestinal problems ( such as blockage, ileus, chronic constipation, Clostridium difficile-associated diarrhea), glaucoma (narrow-angle), difficulty urinating (such as due to enlarged prostate or urethral stricture), personal or family history of regular use/abuse of drugs/alcohol, kidney disease, liver disease, gallbladder disease, underactive thyroid (hypothyroidism), adrenal gland problem (such as Addison's disease), disease of the pancreas (such as pancreatitis), mental/mood disorders (such as toxic psychosis), heart problems (such as irregular heartbeat), a certain spinal problem (kyphoscoliosis).

This drug may make you dizzy or drowsy or cause blurred vision. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely. Avoid alcoholic beverages.

To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

This medication may contain sugar. If you have diabetes, ask your doctor or pharmacist how to use this product safely.

Older adults may be more sensitive to the side effects of this drug, especially dizziness, drowsiness, breathing problems, and trouble urinating.

Children may be more sensitive to the side effects of hydrocodone, especially breathing problems. Children may also be more sensitive to the effects of chlorpheniramine. In young children, antihistamines may cause agitation/excitement instead of drowsiness.

During pregnancy, this medication should be used only when clearly needed. Using it during the last 3 months of pregnancy is not recommended because of possible harm to the unborn baby. Discuss the risks and benefits with your doctor. Infants born to mothers who have used this medication for an extended time may have withdrawal symptoms such as irritability, abnormal/persistent crying, vomiting, or diarrhea. Tell your doctor immediately if you notice any of these symptoms in your newborn.

It is unknown if this drug passes into breast milk or may have undesirable effects on a nursing infant. Tell the doctor immediately if your baby develops unusual sleepiness, difficulty feeding, or trouble breathing. Consult your doctor before breast-feeding.


Tussionex Patient Information Including Side Effects

Brand Names: HyTan, Novasus, S-T Forte 2, TussiCaps, Tussionex PennKinetic

Generic Name: chlorpheniramine and hydrocodone (Pronunciation: KLOR fen IR a meen and HYE droe KOE done)

  • What is chlorpheniramine and hydrocodone (Tussionex)?
  • What are the possible side effects of chlorpheniramine and hydrocodone (Tussionex)?
  • What is the most important information I should know about chlorpheniramine and hydrocodone (Tussionex)?
  • What should I discuss with my healthcare provider before taking chlorpheniramine and hydrocodone (Tussionex)?
  • How should I take chlorpheniramine and hydrocodone (Tussionex)?
  • What happens if I miss a dose (Tussionex)?
  • What happens if I overdose (Tussionex)?
  • What should I avoid while taking chlorpheniramine and hydrocodone (Tussionex)?
  • What other drugs will affect chlorpheniramine and hydrocodone (Tussionex)?
  • Where can I get more information?

What is chlorpheniramine and hydrocodone (Tussionex)?

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

Hydrocodone is a narcotic cough suppressant.

The combination of chlorpheniramine and hydrocodone is used to treat runny or stuffy nose, sneezing, and cough caused by the common cold or flu.

Chlorpheniramine and hydrocodone may also be used for other purposes not listed in this medication guide.

What are the possible side effects of chlorpheniramine and hydrocodone (Tussionex)?

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:

  • weak or shallow breathing;
  • chest tightness;
  • painful urination;
  • urinating less than usual or not at all; or
  • confusion, hallucinations, or unusual behavior.

Less serious side effects may include:

  • dizziness, drowsiness, trouble concentrating;
  • mood changes, anxiety;
  • blurred vision;
  • constipation, nausea, vomiting, loss of appetite;
  • dry mouth or throat;
  • sweating; or
  • mild itching or skin rash.

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.

What is the most important information I should know about chlorpheniramine and hydrocodone (Tussionex)?

Do not take this medication more often than prescribed. An overdose of chlorpheniramine and hydrocodone can cause life-threatening side effects.

To be sure you get the correct dose, measure this medicine carefully with a marked measuring spoon or syringe, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

Before you take chlorpheniramine and hydrocodone, tell your doctor if you have asthma or another breathing disorder, a history of head injury or brain tumor, stomach or intestinal problems, liver or kidney disease, glaucoma, urination problems or an enlarged prostate, Addison's disease, or underactive thyroid.

Chlorpheniramine and hydrocodone 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.

Avoid drinking alcohol while using chlorpheniramine and hydrocodone. Alcohol may increase drowsiness and dizziness.

Hydrocodone may be habit-forming and should be used only by the person it 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.

Do not give this medicine to a child younger than 6 years old.

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