Active Ingredient (In Each 5 Ml)
Dextromethorphan HBr 15 mg
Cough Relief Liquid
FDA Label NDC 63941-309
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Best Choice (valu Merchandisers Company) for the product Cough Relief (NDC 63941-309). 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 ingredient (in each 5 ml), purpose, uses, do not use, ask a doctor before use if you have, when using this product,, stop use and ask a doctor if, if pregnant or breast-feeding,, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Cough suppressant
Uses
- temporarily relieves
- cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
- the impulse to cough to help you get to sleep
Do Not Use
- 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
- cough that occurs with too much phlegm (mucus)
- chronic cough that lasts as occurs with smoking, asthma, or emphysema
When Using This Product,
do not use more than directed
Stop Use And Ask A Doctor If
cough lasts more than 7 days, cough comes back, or occurs with fever, rash or headache that lasts. 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 (1-800-222-1222) right away.
Directions
- take recommended dosage or as directed by a doctor
- measure only with dosing cup provided. Do not use any other dosing device
- keep dosing cup with product
- shake well before using
- mL=milliliter
| age | dose |
| adults and children 12 years and over | 10 mL every 6-8 hours not to exceed 4 doses in 24 hours, |
| children 6 to 11 years of age | 5 mL every 6-8 hours not to exceed 4 doses in 24 hours |
| children under 6 years of age | do not use |
Other Information
- each 5 mL contains: sodium 3 mg
- store between 20-25°C (68-77°F). Do not refrigerate.
Inactive Ingredients
anhydrous citric acid, disodium EDTA, FD&C yellow #6, flavor, glycerin, high fructose corn syrup, hydroxyethyl cellulose, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sucralose, sucrose, xanthan gum
Principal Display Panel
For Ages 6 & Over
Cough Relief
DEXTROMETHORPHAN HBr 15 mg
COUGH SUPPRESSANT
6-8 Hour Relief
ORANGE FLAVOR
Alcohol-Free
FL OZ (mL)
Dosing Cup Included
Contains no fever reducer or pain reliever
TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF PRINTED SAFETY SEAL AROUND BOTTLE OR UNDER CAP IS BROKEN OR MISSING.
PROUDLY DISTRIBUTED BY:
VALU MERCHANDISERS, CO
5000 KANSAS AVE
KANSAS CITY, KS 66106
Package Label
BEST CHOICE Cough Relief Orange Flavor
* Please review the disclaimer below.
