Active Ingredient (In Each 5 Ml)
Dextromethorphan HBr 15 mg
Adult Cough Relief Liquid
FDA Label NDC 83324-134
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 Adult Cough Relief (NDC 83324-134). 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 by 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
Questilons Or Comments?
Call 1-800-935-2362 Monday-Friday 9AM-5PM EST
Principal Display Panel
Cough Relief
Cough Suppressant
Dextromethorphan HBr 15 mg
Cough suppressant
For Ages 6 & Over
6-8 hour Relief
Alcohol-Free
Orange Flavor
FL OZ (mL)
Dosing Cup Included
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 CDMA, Inc.
Novi, MI 48375
Package Label
QUALITY CHOICE Cough Relief
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