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Codeine and Chlorpheniramine Extended-Release: Uses, Side Effects and Dosage

Updated:
Facts
Status:
Prescription (Rx) Controlled substance Schedule III Boxed warning
Strength:
54.3 mg, 8 mg
Brand names:
Drug class:
Active ingredients:
Similar drugs:

Source: FDA drug labeling via NLM DailyMed · About this document

Patient information: uses, side effects, how to take - Codeine and Chlorpheniramine Extended-Release

What is the most important information I should know about CODEINE PHOSPHATE AND CHLORPHENIRAMINE MALEATE?

  • Taking CODEINE PHOSPHATE AND CHLORPHENIRAMINE MALEATE with benzodiazepines, or other central nervous system depressants, including alcohol can cause severe drowsiness, breathing problems (respiratory depression), coma, and death.
  • CODEINE PHOSPHATE AND CHLORPHENIRAMINE MALEATE can cause you to be drowsy. Avoid driving a car or operating machinery during treatment with CODEINE PHOSPHATE AND CHLORPHENIRAMINE MALEATE.

  • Do not give CODEINE PHOSPHATE AND CHLORPHENIRAMINE MALEATE to a child to treat pain after tonsillectomy or adenoidectomy surgery.

    • When you take CODEINE PHOSPHATE AND CHLORPHENIRAMINE MALEATE, some of it changes into morphine in your body.
    • In some children and adults this happens very quickly, and can cause you to stop breathing and cause death due to an overdose.

  • Women who breastfeed should talk to their healthcare provider before taking CODEINE PHOSPHATE AND CHLORPHENIRAMINE MALEATE

    • When you take CODEINE PHOSPHATE AND CHLORPHENIRAMINE MALEATE, some of it changes into morphine in your body.
    • In some women, this happens very quickly. Codeine and morphine pass into your breast milk. A large amount of morphine can cause your baby to die.
  • Call your healthcare provider or get emergency medical help right away if anyone taking CODEINE PHOSPHATE AND CHLORPHENIRAMINE MALEATE, or your breastfeeding baby has any of the symptoms listed below:
  • increased sleepiness
  • difficulty breathing
  • limpness
  • confusion
  • shallow breathing
  • your baby has difficulty breastfeeding
  • Keep CODEINE PHOSPHATE AND CHLORPHENIRAMINE MALEATE 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 CODEINE PHOSPHATE AND CHLORPHENIRAMINE MALEATE, get emergency help right away.
  • CODEINE PHOSPHATE AND CHLORPHENIRAMINE MALEATE can cause serious side effects, including death.
  • Take CODEINE PHOSPHATE AND CHLORPHENIRAMINE MALEATE exactly as prescribed by your healthcare provider. If you take the wrong dose of CODEINE PHOSPHATE AND CHLORPHENIRAMINE MALEATE, you could overdose and die.
  • It is especially important when you take CODEINE PHOSPHATE AND CHLORPHENIRAMINE MALEATE that you know exactly what dose to take.

What is CODEINE PHOSPHATE AND CHLORPHENIRAMINE MALEATE?

CODEINE PHOSPHATE AND CHLORPHENIRAMINE MALEATE is a prescription medicine used to treat cough and upper respiratory symptoms that you can have with allergies or a common cold. CODEINE PHOSPHATE AND CHLORPHENIRAMINE MALEATE is for adults 18 years and older. CODEINE PHOSPHATE AND CHLORPHENIRAMINE MALEATE contains 2 medicines, codeine and chlorpheniramine. Codeine is a narcotic cough suppressant. Chlorpheniramine is an antihistamine.

CODEINE PHOSPHATE AND CHLORPHENIRAMINE MALEATE is a federal controlled substance (CIII) because it contains codeine that can be abused or lead to dependence. Keep CODEINE PHOSPHATE AND CHLORPHENIRAMINE MALEATE in a safe place to prevent misuse and abuse. Selling or giving away CODEINE PHOSPHATE AND CHLORPHENIRAMINE MALEATE may harm others and is against the law.

CODEINE PHOSPHATE AND CHLORPHENIRAMINE MALEATE is not for children under 18 years of age. It is not known if CODEINE PHOSPHATE AND CHLORPHENIRAMINE MALEATE is safe and effective in children.

Who should not take CODEINE PHOSPHATE AND CHLORPHENIRAMINE MALEATE?

Do not give CODEINE PHOSPHATE AND CHLORPHENIRAMINE MALEATE to a child to treat pain after tonsillectomy or adenoidectomy surgery.

Do not take CODEINE PHOSPHATE AND CHLORPHENIRAMINE MALEATE if you are allergic to any of the ingredients in CODEINE PHOSPHATE AND CHLORPHENIRAMINE MALEATE. See the end of this Medication Guide for a complete list of ingredients in CODEINE PHOSPHATE AND CHLORPHENIRAMINE MALEATE. You may have an increased risk of having an allergic reaction to CODEINE PHOSPHATE AND CHLORPHENIRAMINE MALEATE if you are allergic to certain other opioid medicines.

Before taking CODEINE PHOSPHATE AND CHLORPHENIRAMINE MALEATE, 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 (abdomen)
  • have constipation or problems with your intestines
  • have prostate problems
  • have problems with your urinary tract (urethral stricture)
  • plan to have surgery
  • abuse alcohol
  • have kidney or liver problems
  • have thyroid problems, such as hypothyroidism
  • have Addison's disease

  • are pregnant or plan to become pregnant. It is not known if CODEINE PHOSPHATE AND CHLORPHENIRAMINE MALEATE will harm your unborn baby. You and your healthcare provider should decide if you should take CODEINE PHOSPHATE AND CHLORPHENIRAMINE MALEATE while you are pregnant.

  • are breastfeeding or plan to breastfeed. Codeine and chlorpheniramine pass into your breast milk and may harm your baby. You and your healthcare provider should discuss whether you should take CODEINE PHOSPHATE AND CHLORPHENIRAMINE MALEATE or breastfeed. You should not do both.

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

Using CODEINE PHOSPHATE AND CHLORPHENIRAMINE MALEATE with certain other medicines may affect each other. Using CODEINE PHOSPHATE AND CHLORPHENIRAMINE MALEATE with other medicines can cause serious side effects.

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, other mental health problems, or Parkinson's disease, including monoamine oxidase inhibitors (MAOIs), or if you have taken an MAOI in the last 14 days
  • 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 CODEINE PHOSPHATE AND CHLORPHENIRAMINE MALEATE?

  • Take CODEINE PHOSPHATE AND CHLORPHENIRAMINE MALEATE exactly as your healthcare provider tells you.
  • Do not take more than 2 CODEINE PHOSPHATE AND CHLORPHENIRAMINE MALEATE tablets in 24 hours.
  • If you take too much CODEINE PHOSPHATE AND CHLORPHENIRAMINE MALEATE, call your healthcare provider or go to the nearest hospital emergency room right away.

What should I avoid while taking CODEINE PHOSPHATE AND CHLORPHENIRAMINE MALEATE?

  • CODEINE PHOSPHATE AND CHLORPHENIRAMINE MALEATE can cause you to be drowsy. Avoid driving a car or using machinery during treatment with CODEINE PHOSPHATE AND CHLORPHENIRAMINE MALEATE.
  • Do not drink alcohol during treatment with CODEINE PHOSPHATE AND CHLORPHENIRAMINE MALEATE. Drinking alcohol can increase your chances of having serious side effects.

What are the possible side effects of CODEINE PHOSPHATE AND CHLORPHENIRAMINE MALEATE?

CODEINE PHOSPHATE AND CHLORPHENIRAMINE MALEATE may cause serious side effects, including:

  • See “What is the most important information I should know about CODEINE PHOSPHATE AND CHLORPHENIRAMINE MALEATE”
  • Breathing problems (respiratory depression) which can lead to death. Call your healthcare provider or get emergency treatment right away if you have excessive sleepiness, shallow or slow breathing, or confusion.
  • Physical dependence or abuse. Take CODEINE PHOSPHATE AND CHLORPHENIRAMINE MALEATE exactly as your healthcare provider tells you to take it.
  • Stopping CODEINE PHOSPHATE AND CHLORPHENIRAMINE MALEATE suddenly could cause withdrawal symptoms.
  • Increased intracranial pressure
  • Bowel problems including constipation or stomach pain.

The most common side effects of CODEINE PHOSPHATE AND CHLORPHENIRAMINE MALEATE include:

  • nausea and vomiting
  • constipation
  • swelling or boating of your stomach-area
  • stomach-area pain
  • vision problems, including blurred vision and double vision
  • depression
  • drowsiness
  • headache
  • feeling high (euphoria)
  • feeling faint
  • light headedness
  • general feeling of discomfort or illness
  • excitability, nervousness
  • agitation, restlessness, irritability
  • sleepiness
  • difficulty sleeping (insomnia)
  • unable to control muscle movements
  • tremor

These are not all the possible side effects of CODEINE PHOSPHATE AND CHLORPHENIRAMINE MALEATE.

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 CODEINE PHOSPHATE AND CHLORPHENIRAMINE MALEATE?

  • Store CODEINE PHOSPHATE AND CHLORPHENIRAMINE MALEATE in a safe place between 68oF to 77oF (20oC to 25oC).
  • Keep CODEINE PHOSPHATE AND CHLORPHENIRAMINE MALEATE in a tightly closed, child-resistant container and out of the light.
  • Safely throw away medicine that is out of date or no longer needed.
  • Keep CODEINE PHOSPHATE AND CHLORPHENIRAMINE MALEATE and all medicines out of the reach of children.

General information about the safe and effective use of CODEINE PHOSPHATE AND CHLORPHENIRAMINE MALEATE.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use CODEINE PHOSPHATE AND CHLORPHENIRAMINE MALEATE for a condition for which it was not prescribed. Do not give CODEINE PHOSPHATE AND CHLORPHENIRAMINE MALEATE 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 CODEINE PHOSPHATE AND CHLORPHENIRAMINE MALEATE that is written for health professionals.

What are the ingredients in CODEINE PHOSPHATE AND CHLORPHENIRAMINE MALEATE?

Active ingredients: codeine and chlorpheniramine

Inactive ingredients: Hypromellose, lactose monohydrate, cellulose microcrystalline, polysorbate 80, magnesium stearate, and colloidal silicon dioxide.

Manufactured By: Nexgen Pharma, Inc.

Irvine, CA 92614

For more information go to www.nexgenpharma.com or call 888-710-0006

This Medication Guide has been approved by the U.S. Food and Drug Administration Issued: January 2017

About this document

Source: FDA drug labeling via NLM DailyMed · Application number: NDA 206323 · View the label on DailyMed

Revision date stated in the text: January 2017

Found a mistake? Write to us via the contact page.

The information on this site does not replace the advice of a doctor or pharmacist.

Drug information for Codeine and Chlorpheniramine Extended-Release

Rx or OTC
Prescription (Rx), Controlled substance?
  • This drug is available only with a prescription from a licensed healthcare provider.
  • This drug is a controlled substance under the federal Controlled Substances Act.
  • Rx
Controlled substance Schedule IIISchedule III: potential for abuse less than Schedule II; abuse may lead to moderate or low physical dependence or high psychological dependence.
Boxed warning Yes – this drug has a boxed warning (also called a black box warning), the strongest warning of the FDA.
Drug class Histamine-1 Receptor Antagonist, Opioid Agonist
Active ingredients Codeine phosphate 54.3 mg, Chlorpheniramine maleate 8 mg
Dosage form Tablet, extended release
Route Oral
Marketing status not in the current FDA NDC Directory
Company (applicant) MAINPOINTE
FDA approval NDA 206323New Drug Application (NDA) Approved June 22, 2015
Manufacturers 1 labelers list this drug on DailyMed
Packages (NDC)
Package
54.3 mg, 8 mg – 100 in 1 bottle NDC 0722-7184-01

Source: FDA drug labeling via NLM DailyMed, data as of October 31, 2026. FDA data (DailyMed, Orange Book, Drug Shortages, enforcement reports). Not a substitute for the advice of a doctor or pharmacist.