Active Ingredients (In Each 20 Ml)
Dextromethorphan HBr, USP 20 mg
Guaifenesin, USP 200 mg
Cvs Sugar Free Adult Cough Plus Chest Congestion Dm
FDA Label NDC 51316-749
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 Sugar Free Adult Cough Plus Chest Congestion Dm (NDC 51316-749). 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 20 ml), purposes, indications & usage, warnings, otc - do not use, otc - ask doctor, otc - stop use, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purposes
Cough suppressant
Expectorant
Indications & Usage
Uses
▪ temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold▪ helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes
Warnings
Warnings
Otc - Do Not Use
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.
Otc - Ask Doctor
Ask a doctor before use if you have
▪ cough that occurs with too much phlegm (mucus)▪ cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema
Otc - Stop Use
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.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
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.
Dosage & Administration
Directions
▪ do not take more than 6 doses in any 24-hour period▪ measure only with dosing cup provided▪ keep dosing cup with product▪ ml = milliliter▪ this adult product is not intended for use in children under 12 years of age
age | dose |
adults and children 12 years and over | 20 ml every 4 hours |
children under 12 years | do not use |
Storage And Handling
Other information
- each 20 ml contains: sodium 7 mg
- store at room temperature. Do not refrigerate.
Inactive Ingredient
Inactive ingredients
anhydrous citric acid, disodium edetate, FD&C Red No 40, flavors, potassium citrate, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum
Otc - Questions
Questions or comments?
1-866-467-2748
Principal Display Panel
Compare to the active ingredients in Adult Robitussin® Sugar-Free Cough + Chest Congestion DM*
NDC 51316-749-08
SUGAR-FREE
Adult
Cough+Chest
Congestion DM
Dextromethorphan HBr (Cough Suppressant)
Guaifenesin (Expectorant)
- Controls Cough
- Relieves Chest Congestion
- Thins & Loosens Mucus
Specially
Formulated
for DIABETICS
For Ages 12 & Over
8 FL OZ (237 ml)
Distributed by:
*This product is not manufactured or distributed by GSK Consumer Healthcare, owner of the registered trademark Adult Robitussin® Sugar-Free Cough+Chest Congestion DM.
Cvs Sugar-free Adult Cough+chest Congestion Dm 237 mL (Robitussin 02)
* Please review the disclaimer below.
