Active Ingredient (In Each 5 Ml, 1 Teaspoon)
Dextromethorphan HBr 15 mg
Cough Relief Liquid
FDA Label NDC 63941-455
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 63941-455). 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, 1 teaspoon), purpose, uses, do not use, ask a doctor before use if you have, stop use and ask a doctor if, when using this product, 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
- chronic cough that lasts as occurs with smoking, asthma or emphysema
- cough that occurs with too much phlegm (mucus)
Stop Use And Ask A Doctor If
cough lasts more than 7 days, comes back, or is accompanied by fever, rash or headache that lasts. These could be signs of a serious condition.
When Using This Product
do not use more than directed
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 under 11 years | 5 mL every 6-8 hours not to exceed 4 doses in 24 hours |
| children under 6 years | 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
citric acid, edetate disodium, FD&C yellow #6 flavor, glycerin, high fructose corn syrup, hydroxyethyl cellulose, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sucralose, sucrose, xanthan gum
Questions Or Comments?
Call 1-877-753-3935 Monday-Friday 9AM-5PM EST
Principal Display Panel
COUGH RELIEF
DEXTROMETHORPHAN HBr 15 mg
COUGH SUPPRESSANT
RELIEVES:
- COUGH AND IMPULSE TO COUGH
- MINOR THROAT AND BRONCHIAL IRRITATION
ORANGE FLAVOR
FOR AGES 6 YEARS AND OVER
ALCOHOL FREE
6-8 HOUR RELIEF
FL OZ (mL)
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:
ASSOCIATED WHOLESALE GROCERS, INC.
KANSAS CITY, KANSAS 66106
Package Label
ALWAYS SAVE Cough Relief
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