Active Ingredients (In Each 10 Ml)
Chlorpheniramine maleate, USP 2 mg
Dextromethorphan HBr, USP 15 mg
Cvs Childrens Cough And Cold Liquid
FDA Label NDC 51316-745
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Cvs Pharmacy for the product Cvs Childrens Cough And Cold (NDC 51316-745). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients (in each 10 ml), purposes, uses, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purposes
Antihistamine
Cough suppressant
Uses
▪ temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold▪ temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:▪ runny nose▪ sneezing▪ itchy, watery eyes▪ itching of the nose or throat
Do Not Use
- to sedate a child or to make a child sleepy
- if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
Ask A Doctor Before Use If You Have
- trouble urinating due to an enlarged prostate gland
- glaucoma
- a cough that occurs with too much phlegm (mucus)
- a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysema
Ask A Doctor Or Pharmacist Before Use If You Are
taking sedatives or tranquilizers
When Using This Product
▪ do not use more than directed▪ marked drowsiness may occur▪ avoid alcoholic drinks▪ alcohol, sedatives, and tranquilizers may increase drowsiness▪ be careful when driving a motor vehicle or operating machinery▪ excitability may occur, especially in children
Stop Use And Ask A Doctor If
cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.
If Pregnant Or Breast-Feeding,
ask a health professional before use.
Keep Out Of Reach Of Children.
In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222.
Directions
▪ measure only with dosing cup provided▪ keep dosing cup with product▪ mL = milliliter▪ do not take more than 4 doses in any 24-hour period
| age | dose |
|---|---|
Children under 6 years | do not use |
children 6 to under 12 years | 10 mL every 6 hours |
adults and children 12 years and older | 20 mL every 6 hours |
Other Information
▪ each 10 mL contains: sodium 7 mg▪ store at room temperature, Do not refrigerate.
Inactive Ingredients
citric acid, FD&C red no. 40, Glycerin, lactic acid, natural and artificial flavors, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose
Questions Or Comments?
1-866-467-2748
Product Packaging
Compare to the active ingredients in Children’s Robitussin® Cough & Cold Long–Acting*
NDC 51316-745-04
Children’s COUGH & COLD
Chlorpheniramine Maleate USP 2 mg (Antihistamine)
Dextromethorphan HBr, USP 15 mg (Cough Suppressant)
Long-Acting
Relieves:
- Cough up to 8 hours
- Runny nose
Fruit Punch Flavor
Naturally and Artificially Flavored
4 FL OZ (118 mL)
IMPORTANT: Keep this carton for future reference on full labeling
Distributed by:
Cvs Childrens Cough & Cold 4 Fl Oz Fruit Punch Flavor (Paa009240)
* Please review the disclaimer below.
