Active Ingredient (In Each 5 Ml)
Dextromethorphan HBr 15 mg
Cough Relief Liquid
FDA Label NDC 63868-957
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Quality Choice (chain Drug Marketing Association) for the product Cough Relief (NDC 63868-957). 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, 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 occurs with 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 no 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, 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 1-248-449-9300 Monday-Friday 9AM-5PM EST
Principal Display Panel
COUGH RELIEF
Cough Suppressant
Dextromehtorphan HBr 15 mg
Cough Suppressant
For Ages 6 & Over
6-8 Hour Relief
Alcohol Free
Orange Flavor
FL OZ (mL)
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.
Distributed by C.D.M.A., Inc,©
43157 W. Nine Mile
Novi, MI 48376-0995
Package Label
QUALITY CHOICE Cough relief Orange Flavor
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