PROMETHAZINE HCL, PHENYLEPHRINE HCL, CODEINE PHOSPHATE- promethazine, phenylephrine, codeine syrup 
Amneal Pharmaceuticals LLC

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MEDICATION GUIDE

Promethazine Hydrochloride (proe meth’a zeen hye”droe klor’ide), Phenylephrine Hydrochloride (fen”il ef’rin hye” droe klor’ ide) and Codeine Phosphate (koe’deen fos’fate) Oral Solution, USP

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What is the most important information I should know about Promethazine Hydrochloride, Phenylephrine Hydrochloride and Codeine Phosphate Oral Solution?

Promethazine Hydrochloride, Phenylephrine Hydrochloride and Codeine Phosphate Oral Solution is not for children under 18 years of age.

Promethazine Hydrochloride, Phenylephrine Hydrochloride and Codeine Phosphate Oral Solution can cause serious side effects, including:

Call your healthcare provider or get emergency medical help right away if anyone taking Promethazine Hydrochloride, Phenylephrine Hydrochloride and Codeine Phosphate Oral Solution, or your breastfeeding baby, has any of the symptoms below:

  • increased sleepiness
  • confusion
  • difficulty breathing
  • shallow breathing
  • limpness

Keep Promethazine Hydrochloride, Phenylephrine Hydrochloride and Codeine Phosphate Oral Solution in a safe place away from children.  Accidental use of even 1 dose of Promethazine Hydrochloride, Phenylephrine Hydrochloride and Codeine Phosphate Oral Solution, especially by a child, is a medical emergency and can cause breathing problems (respiratory depression) which can lead to death. If a child accidentally takes Promethazine Hydrochloride, Phenylephrine Hydrochloride and Codeine Phosphate Oral Solution, get emergency help right away.

What is Promethazine Hydrochloride, Phenylephrine Hydrochloride and Codeine Phosphate Oral Solution?

Who should not take Promethazine Hydrochloride, Phenylephrine Hydrochloride and Codeine Phosphate Oral Solution?

 

Promethazine Hydrochloride, Phenylephrine Hydrochloride and Codeine Phosphate Oral Solution is not for children under 18 years of age.  See “What is the most important information I should know about Promethazine Hydrochloride, Phenylephrine Hydrochloride and Codeine Phosphate Oral Solution?” 

Do not take Promethazine Hydrochloride, Phenylephrine Hydrochloride and Codeine Phosphate Oral Solution if you:

Ask your healthcare provider if you have any questions about this information.

Before you take Promethazine Hydrochloride, Phenylephrine Hydrochloride and Codeine Phosphate Oral Solution, tell your healthcare provider about all of your medical conditions, including if you:

  • have a drug addiction
  • have lung or breathing problems
  • have a fever and are coughing up mucus
  • have had a recent head injury
  • have had brain tumor or other brain problems
  • have or have had seizures
  • have pain in your stomach-area (abdomen)
  • have constipation or other bowel problems
  • have bile duct or pancreas problems
  • have glaucoma (increased pressure in eyes)
  • have prostate problems
  • have kidney or liver problems
  • have problems with your urinary tract or difficulty urinating
  • have high blood pressure
  • have heart or blood vessel (cardiovascular) problems including peripheral vascular insufficiency
  • have uncontrolled spasms of your face, neck or muscles of your body, arms and legs (dystonia)
  • have a history of neuroleptic malignant syndrome (NMS)
  • have blood disorders including low white blood cells
  • have low blood pressure (hypotension)
  • have adrenal gland problems
  • plan to have surgery

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

Taking Promethazine Hydrochloride, Phenylephrine Hydrochloride and Codeine Phosphate Oral Solution with certain other medicines can cause side effects or affect how well Promethazine Hydrochloride, Phenylephrine Hydrochloride and Codeine Phosphate Oral Solution or the other medicines work. Do not start or stop taking other medicines without talking to your healthcare provider.

Especially tell your healthcare provider if you:

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

How should I take Promethazine Hydrochloride, Phenylephrine Hydrochloride and Codeine Phosphate Oral Solution?

See “What is the most important information I should know about Promethazine Hydrochloride, Phenylephrine Hydrochloride and Codeine Phosphate Oral Solution?

What should I avoid while taking Promethazine Hydrochloride, Phenylephrine Hydrochloride and Codeine Phosphate Oral Solution?

Avoid the use of Promethazine Hydrochloride, Phenylephrine Hydrochloride and Codeine Phosphate Oral Solution if you:

What are the possible side effects of Promethazine Hydrochloride, Phenylephrine Hydrochloride and Codeine Phosphate Oral Solution?

Promethazine Hydrochloride, Phenylephrine Hydrochloride and Codeine Phosphate Oral Solution may cause serious side effects, including:

  • high fever
  • stiff muscles
  • confusion
  • sweating
  • changes in pulse, heart rate, or blood pressure
  • nausea
  • vomiting
  • not wanting to eat (anorexia)
  • fatigue
  • weakness
  • dizziness
  • low blood pressure

The most common side effects of Promethazine Hydrochloride, Phenylephrine Hydrochloride and Codeine Phosphate Oral Solution include:

  • sleepiness
  • confusion
  • coordination problems
  • decrease in mental and physical performance
  • lack of energy
  • lightheadedness
  • dizziness
  • headache
  • irritability
  • anxiety
  • restlessness
  • nervousness
  • tremor
  • dry mouth
  • difficulty urinating
  • sweating
  • shortness of breath
  • nausea
  • vomiting
  • constipation
  • high blood pressure
  • fast or irregular heart beat

These are not all the possible side effects of Promethazine Hydrochloride, Phenylephrine Hydrochloride and Codeine Phosphate Oral Solution.

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 Promethazine Hydrochloride, Phenylephrine Hydrochloride and Codeine Phosphate Oral Solution?

How should I dispose of Promethazine Hydrochloride, Phenylephrine Hydrochloride and Codeine Phosphate Oral Solution?

Remove unused Promethazine Hydrochloride, Phenylephrine Hydrochloride and Codeine Phosphate Oral Solution from the container and mix it with an undesirable, non-toxic substance such as cat litter or used coffee grounds to make it less appealing to children and pets.  Place the mixture in a container such as a sealed plastic bag and throw it away in the household trash.  You can also follow your state or local guidelines on how to safely throw away Promethazine Hydrochloride, Phenylephrine Hydrochloride and Codeine Phosphate Oral Solution.

General information about the safe and effective use of Promethazine Hydrochloride, Phenylephrine Hydrochloride and Codeine Phosphate Oral Solution.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Promethazine Hydrochloride, Phenylephrine Hydrochloride and Codeine Phosphate Oral Solution for a condition for which it was not prescribed.  Do not give Promethazine Hydrochloride, Phenylephrine Hydrochloride and Codeine Phosphate Oral Solution 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 Promethazine Hydrochloride, Phenylephrine Hydrochloride and Codeine Phosphate Oral Solution that is written for health professionals.

What are the ingredients in Promethazine Hydrochloride, Phenylephrine Hydrochloride and Codeine Phosphate Oral Solution?

Active ingredients: codeine phosphate USP, promethazine hydrochloride USP, and phenylephrine hydrochloride USP

Inactive ingredients:

anhydrous citric acid, ascorbic acid, edetate disodium, glycerin, methylparaben, natural & artificial citrus flavor FN-7176, purified water, saccharin sodium, sodium benzoate, sodium metabisulfite, sodium citrate, and sucrose.

Manufactured by:
Amneal Pharmaceuticals LLC
Branchburg, NJ 08876

Distributed by:
Amneal Pharmaceuticals LLC
Glasgow, KY 42141

For more information, go to www.amneal.com or call 1-877-835-5472.

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

Rev. 09-2023-08

Revised: 1/2024
Amneal Pharmaceuticals LLC