Description
What is Tris Promethazine Hydrochloride and Codeine Phosphate Oral Solution?
Tris Promethazine Hydrochloride and Codeine Phosphate Oral Solution is a prescription medicine used in adults to temporarily treat cough and upper respiratory symptoms that you can have with allergies or a common cold. Tris Promethazine Hydrochloride and Codeine Phosphate Oral Solution contains 2 medicines, Tris Promethazine and codeine. Promethazine is an antihistamine. Codeine is an opioid (narcotic) cough suppressant.
Promethazine Hydrochloride and Codeine Phosphate Oral Solution is a federal controlled substance (C-V) because it contains codeine that can be abused or lead to dependence. Keep Promethazine Hydrochloride and Codeine Phosphate Oral Solution in a safe place to prevent misuse and abuse. Selling or giving away Promethazine Hydrochloride and Codeine Phosphate Oral Solution may harm others, and is against the law. Tell your healthcare provider if you have ever abused or been dependent on alcohol, prescription medicines or street drugs.
Who should not take Tris Promethazine Hydrochloride and Codeine Phosphate Oral Solution?
Promethazine 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 Tris Promethazine Hydrochloride and Codeine Phosphate Oral Solution?”
Do not take Promethazine Hydrochloride and Codeine Phosphate Oral Solution if you:
- have severe breathing problems (respiratory depression). See “What is the most important information I should know about Tris Promethazine Hydrochloride and Codeine Phosphate Oral Solution?”
- have a blockage (obstruction) in your bowel such as a paralytic ileus.
take a medicine called a monoamine oxidase inhibitor (MAOI).Do not take an MAOI within 14 days after you stop taking Promethazine Hydrochloride and Codeine Phosphate Oral Solution. - Do not start taking Promethazine Hydrochloride and Codeine Phosphate Oral Solution if you stopped taking an MAOI in the last 14 days.
- have a type of glaucoma called “narrow angle glaucoma”.
- have problems with your urinary tract or difficulty urinating (urinary retention).
- are allergic to promethazine, codeine, or any of the ingredients in Promethazine Hydrochloride and Codeine Phosphate Oral Solution. See the end of this Medication Guide for a complete list of ingredients in Tris Promethazine Hydrochloride and Codeine Phosphate Oral Solution.
Is it safe to take promethazine while pregnant?
Promethazine and pregnancy
If you are pregnant or plan to become pregnant. Tris Promethazine Hydrochloride and Codeine Phosphate Oral Solution can harm your unborn baby. Also if you are breastfeeding or plan to breastfeed. Codeine passes into your breast milk and can cause serious side effects in your baby including increased sleepiness, breathing problems (respiratory depression), and death. It is not known if promethazine can pass into your breast milk. You and your healthcare provider should decide if you will take Promethazine Hydrochloride and Codeine Phosphate Oral Solution or breastfeed. You should not do both.
Does promethazine affect baby?
Furthermore if you plan to have children. Tris Promethazine Hydrochloride and Codeine Phosphate Oral Solution may affect the ability to have a child in females and males (fertility problems). It is not known if these fertility problems will be reversible, even after you stop taking Promethazine Hydrochloride and Codeine Phosphate Oral Solution.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
Can you take Tris Promethazine Hydrochloride and Codeine Phosphate Oral Solution with certain other medicines?
Do not start or stop taking other medicines without talking to your healthcare provider. Especially tell your healthcare provider if you:
- take pain medicines such as opioids (narcotics).
- take cold or allergy medicines that contain antihistamines or cough suppressants.
drink alcohol. - take muscles relaxants.
- take certain medicines used to treat mood, anxiety, psychotic or thought disorders, or depression, including monoamine oxidase inhibitors (MAOIs), tricyclics, selective serotonin reuptake inhibitors (SSRIs), selective serotonin norepinephrine reuptake inhibitors (SNRIs), or antipsychotics.
- take water pills (diuretics).
- take medicines called “anticholinergics” used to treat asthma, chronic bronchitis (COPD), or stomach problems.
Ask your healthcare provider if you are not sure if you take one of these medicines.
How should I take Tris Promethazine Hydrochloride and Codeine Phosphate Oral Solution?
Take Promethazine Hydrochloride and Codeine Phosphate Oral Solution exactly as your healthcare provider tells you to take it. Do not change your dose without talking to your healthcare provider.
Take Promethazine Hydrochloride and Codeine Phosphate Oral Solution by mouth only.
Do not take more than 30 mL of Promethazine Hydrochloride and Codeine Phosphate Oral Solution in 24 hours.
Take Promethazine Hydrochloride and Codeine Phosphate Oral Solution using an accurate milliliter (mL) measuring device. If you do not have one, ask your pharmacist to give you a measuring device to measure the correct amount of Promethazine Hydrochloride and Codeine Phosphate Oral Solution. Do not use a household teaspoon to measure your medicine. You may accidently take too much.
Do not overfill the measuring device.
Rinse your measuring device with water after each use.
If you take too much Promethazine Hydrochloride and Codeine Phosphate Oral Solution, call your healthcare provider or go to the nearest hospital emergency room right away.
Tell your healthcare provider if your cough does not get better within 5 days of treatment with Promethazine Hydrochloride and Codeine Phosphate Oral Solution.
What should I avoid while taking Promethazine Hydrochloride and Codeine Phosphate Oral Solution?
Avoid the use of Promethazine Hydrochloride and Codeine Phosphate Oral Solution if you:
are pregnant. Use of Promethazine Hydrochloride and Codeine Phosphate Oral Solution during pregnancy can cause withdrawal symptoms in your newborn baby that could be life-threatening if not recognized and treated. Tell your healthcare provider right away if you are pregnant or think you may be pregnant.
are breastfeeding. Use of Promethazine Hydrochloride and Codeine Phosphate Oral Solution while breastfeeding can cause severe breathing problems (respiratory depression) in your breastfed infant that could be life-threatening.
What are the possible side effects of Promethazine Hydrochloride and Codeine Phosphate Oral Solution?
The most common side effects of Promethazine 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
nausea
vomiting
not wanting to eat (anorexia)
fatigue
weakness
dizziness
low blood pressure
Changes in laboratory blood levels, including high blood sugar and false pregnancy test reading.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 and Codeine Phosphate Oral Solution?
Store Tris Promethazine Hydrochloride and Codeine Phosphate Oral Solution at room temperature between 68°F to 77°F (20°C to 25°C).
Store Promethazine Hydrochloride and Codeine Phosphate Oral Solution in a tightly closed container, in a dry, cool place away from heat or direct sunlight.
Keep Promethazine Hydrochloride and Codeine Phosphate Oral Solution and all medicines out of the reach of children.
How should I dispose of Promethazine Hydrochloride and Codeine Phosphate Oral Solution?
What are the ingredients in Promethazine Hydrochloride and Codeine Phosphate Oral Solution?
Active ingredients: promethazine hydrochloride and codeine phosphate
Inactive ingredients: anhydrous citric acid, ascorbic acid, D&C Red # 33, edetate disodium, FD&C Blue #1, methylparaben, peach-mint flavor, propylene glycol, propylparaben, purified water, saccharin sodium, sodium benzoate, sodium citrate anhydrous, sodium metabisulfite, sucrose.
Manufactured by: Tris Pharma, Inc., Monmouth Junction, NJ 08852
For more information, go to WWW.TRISPHARMA.COM or call (732) 940-0358.
LB8462
Rev. 02
This Medication Guide has been approved by the U.S. Food and Drug Administration Revised:3/2024
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