PROMETHAZINE WITH CODEINE- promethazine hydrochloride and codeine phosphate solution 
Pharmaceutical Associates, Inc.

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MEDICATION GUIDE

PROMETHAZINE WITH CODEINE (proe METH a zeen with KOE deen) ORAL SOLUTION
(promethazine hydrochloride and codeine phosphate)
oral solution, C-V

What is the most important information I should know about PROMETHAZINE WITH CODEINE ORAL SOLUTION?

PROMETHAZINE WITH CODEINE ORAL SOLUTION is not for children under 18 years of age.

PROMETHAZINE WITH CODEINE ORAL SOLUTION can cause serious side effects, including:

Call your healthcare provider or get emergency medical help right away if anyone taking PROMETHAZINE WITH CODEINE ORAL SOLUTION, or your breastfeeding baby, has any of the symptoms below:

Keep PROMETHAZINE WITH CODEINE ORAL SOLUTION in a safe place away from children. Accidental use of even 1 dose of PROMETHAZINE WITH CODEINE 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 WITH CODEINE ORAL SOLUTION, get emergency help right away.

What is PROMETHAZINE WITH CODEINE ORAL SOLUTION?

Who should not take PROMETHAZINE WITH CODEINE ORAL SOLUTION?

PROMETHAZINE WITH CODEINE ORAL SOLUTION is not for children under 18 years of age. See “ What is the most important information I should know about PROMETHAZINE WITH CODEINE ORAL SOLUTION?

Do not take PROMETHAZINE WITH CODEINE ORAL SOLUTION if you:

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

Before you take PROMETHAZINE WITH CODEINE ORAL SOLUTION, tell your healthcare provider about all of your medical conditions, including if you:

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

Taking PROMETHAZINE WITH CODEINE ORAL SOLUTION with certain other medicines can cause side effects or affect how well PROMETHAZINE WITH CODEINE 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 WITH CODEINE ORAL SOLUTION?

What should I avoid while taking PROMETHAZINE WITH CODEINE ORAL SOLUTION?

Avoid the use of PROMETHAZINE WITH CODEINE ORAL SOLUTION if you:

What are the possible side effects of PROMETHAZINE WITH CODEINE ORAL SOLUTION?

PROMETHAZINE WITH CODEINE ORAL SOLUTION may cause serious side effects, including:

The most common side effects of PROMETHAZINE WITH CODEINE ORAL SOLUTION include:

These are not all the possible side effects of PROMETHAZINE WITH CODEINE 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 WITH CODEINE ORAL SOLUTION?

How should I dispose of PROMETHAZINE WITH CODEINE ORAL SOLUTION?

Remove unused PROMETHAZINE WITH CODEINE 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 WITH CODEINE ORAL SOLUTION.

General information about the safe and effective use of PROMETHAZINE WITH CODEINE ORAL SOLUTION.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use PROMETHAZINE WITH CODEINE ORAL SOLUTION for a condition for which it was not prescribed. Do not give PROMETHAZINE WITH CODEINE 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 WITH CODEINE ORAL SOLUTION that is written for health professionals.

What are the ingredients in PROMETHAZINE WITH CODEINE ORAL SOLUTION?

Active ingredients: promethazine hydrochloride and codeine phosphate

Inactive ingredients: Ascorbic acid, citric acid, FD&C blue #1, FD&C red #3, grape blend flavor, menthol, methylparaben, propylene glycol, propylparaben, purified water, saccharin sodium, sodium benzoate, sodium citrate and sucrose.

Distributed by: Pharmaceutical Associates, Inc., Greenville, SC 29605

For more information, call 1-800-845-8210.

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

Revision: 07/2020

Revised: 10/2020
Pharmaceutical Associates, Inc.