HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX EXTENDED-RELEASE- hydrocodone polistirex and chlorpheniramine polistirex suspension, extended release 
Tris Pharma Inc

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MEDICATION GUIDE

Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release
Suspension CII

(hye” droe koe’ done pol” i stye’ rex and klor” fen ir’ a mean pol” i stye’ rex) 

What is the most important information I should know about Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release Suspension?

• Taking Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release Suspension with benzodiazepines, or other central nervous system depressants, including alcohol can cause severe drowsiness, breathing problems (respiratory depression), coma, and death.

• Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release Suspension can cause you to be drowsy. Avoid driving a car or operating machinery during treatment with Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release Suspension.

• Women who breastfeed should talk to their healthcare provider before taking Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release Suspension.

• Call your healthcare provider or get emergency medical help right away if anyone taking Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release Suspension has any of the symptoms below:

  • increased sleepiness

  • confusion

  • difficulty breathing

  • shallow breathing

  • limpness

  • your baby has difficulty breastfeeding

• Keep Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release Suspension in a safe place away from children. Accidental use by a child is a medical emergency and can cause death. If a child accidentally takes Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release Suspension, get emergency medical help right away.

• Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release Suspension can cause serious side effects, including death.

• Take Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release Suspension exactly as prescribed by your healthcare provider. If you take the wrong dose of Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release Suspension, you could overdose and die.

• Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release Suspension is not for children under 6 years of age.

  What is Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release Suspension?

• Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release Suspension is a prescription medicine used to treat cough and upper respiratory symptoms you can have with allergies or a cold. Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release Suspension is for adults and children age 6 years and older. Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release Suspension contains 2 medicines, hydrocodone and chlorpheniramine. Hydrocodone is a narcotic cough suppressant. Chlorpheniramine is an antihistamine.

Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release Suspension is a federal controlled substance (CII) because it contains hydrocodone that can be abused or lead to dependence. Keep Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release Suspension in a safe place to prevent misuse and abuse. Selling or giving away Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release Suspension may harm others, and is against the law. Tell your healthcare provider if you have abused or been dependent on alcohol, prescription medicines or street drugs.

• Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release Suspension is not for children under 6 years of age.
Who should not take Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release Suspension?

• Do not take Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release Suspension if you are allergic to any of the ingredients in Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release Suspension. See the end of this Medication Guide for a complete list of ingredients. You may have an increased risk of having an allergic reaction to Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release Suspension if you are allergic to certain other opioid medicines.

Do not give Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release Suspension to a child under 6 years of age. It can cause breathing problems that can lead to death.

Before you take Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release Suspension, tell your healthcare provider about all of your medical conditions, including if you:

  • have a drug dependence

  • have lung or breathing problems

  • have had a head injury

  • have pain in your stomach-area (abdomen)

  • have a history of severe or persistent cough

  • have glaucoma

  • have prostate problems

  • have problems with your urinary tract (urethral stricture)

  • an to have surgery

  • drink alcohol

  • have kidney or liver problems

  • have diabetes

  • have thyroid problems, such as hypothyroidism

  • Addison’s disease

• are pregnant or plan to become pregnant. It is not known if Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release Suspension will harm your unborn baby. You and your healthcare provider should decide if you should take Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release Suspension while you are pregnant.

• are breastfeeding or plan to breastfeed. It is not known if Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release Suspension passes into your breast milk. You and your healthcare provider should decide if you will take Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release Suspension or breastfeed. You should not do both.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Taking Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release Suspension with certain other medicines can cause side effects or affect how well Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release Suspension or the other medicines work. Do not start or stop other medicines without talking to your healthcare provider.

Especially tell your healthcare provider if you:

• take pain medicines such as narcotics

• take cold or allergy medicines that contain antihistamines or cough suppressants

• take medicines for mental illness (anti-psychotics, anti-anxiety)

• drink alcohol

• take medicines for depression, including monoamine oxidase inhibitors (MAOIs) and tricyclics

• take medicines for stomach or intestine problems

Ask your healthcare provider if you are not sure if you take one of these medicines.

How should I take Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release Suspension?

• Take Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release Suspension exactly as your healthcare provider tells you to take it.

• Your healthcare provider will tell you how much Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release Suspension to take and when to take it. Do not change your dose without talking to your healthcare provider.

• Shake Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release Suspension well before each use.

• Do not mix Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release Suspension with other liquids or medicines. Mixing may change how Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release Suspension works.

• Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release Suspension can be taken with or without food.

Only measure Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release Suspension with the dosing cup that comes with your prescription. If you do not have a dosing cup for your medicine, ask your pharmacist to give you a measuring device to help you measure the correct amount of Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release Suspension. Do not use a household teaspoon to measure your medicine. You may accidently take too much.

  • The dosing cup is calibrated for measuring 2.5 mL and 5 mL dosages. Find the marked line for the dose you are taking.

  • Fill the cup so the medicine is leveled to the dose that has been prescribed. Do not fill over the dosage line.

  • Rinse the measuring cup with water after each use.

Measuring Cup


If you take too much Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release Suspension, call your healthcare provider or go to the nearest hospital emergency room right away.

What are the possible side effects of Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release Suspension?

Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release Suspension may cause serious side effects, including:

See “What is the most important information I should know about Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release Suspension?”

Breathing problems (respiratory depression) which can lead to death. Call your healthcare provider or get emergency treatment right away if you are sleeping more than usual, have shallow or slow breathing, or confusion.

• Increased intracranial pressure.

Physical dependence or abuse. Take Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release Suspension exactly as your healthcare provider tells you to take it. Stopping Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release Suspension suddenly can cause withdrawal symptoms.

Bowel problems including constipation or stomach pain.

The most common side effects of Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release Suspension include:

• sleepiness

• confusion

• nausea and vomiting

• difficulty urinating

• trouble breathing

These are not all the possible side effects of Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release Suspension.

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

How should I store Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release Suspension?

• Store Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release Suspension at room temperature between 68°F to 77°F (20°C to 25°C).

• Safely throw away medicine that is out of date or no longer needed.

Keep Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release Suspension and all medicines out of the reach of children.
General information about the safe and effective use of Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release Suspension.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release Suspension for a condition for which it was not prescribed. Do not give Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release Suspension to other people, even if they have the same symptoms that you have. It may harm them.

You can ask your pharmacist or healthcare provider for information about Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release Suspension that is written for health professionals.

What are the ingredients in Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release Suspension?

Active Ingredient: hydrocodone polistirex and chlorpheniramine polistirex

Inactive Ingredients: Ascorbic acid, D&C Yellow No. 10, flavors, high fructose corn syrup, modified food starch, methylparaben, polysorbate 80, polyvinyl acetate, propylene glycol, propylparaben, purified water, sodium ascorbate, sodium metabisulfite, sodium polystyrene sulfonate, sucrose, triacetin, xanthan gum.

Manufactured by:
Tris Pharma, Inc.
Monmouth Junction, NJ 08852


For more information about Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release Suspension, contact Tris Pharma Inc., at 732-940-0358 or go to www.trispharma.com.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Issued: 09/2017


Revised: 10/2017
Tris Pharma Inc