Active Ingredients (In Each 20 Ml)
Dextromethorphan HBr 20 mg
Guaifenesin 400 mg
Cough And Congestion Solution
FDA Label NDC 51316-500
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 Woonsocket Prescription Center, Incorporated for the product Cough And Congestion (NDC 51316-500). 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), purpose, uses, do not use, ask a doctor before use if you have, stop use and ask a doctor if, if pregnant or breast-feeding,, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Cough suppressant
Expectorant
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
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)
- persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
Stop Use And Ask A Doctor If
cough persists more than 7 days, tends to recur, or is accompanied by a fever, rash, or persistent headache. 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 right away.
Directions
- do not take more than directed
- do not take more than 6 doses in any 24-hour period
- mL = milliliter
- only use the dose cup provided
- adults and children 12 years and over: 20 mL in dosing cup provided every 4 hours
- children under 12 years: do not use
Other Information
- each 20 mL contains: sodium 16 mg
- store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
- see end flap for expiration date and lot number
Inactive Ingredients
anhydrous citric acid, FD&C blue #1, FD&C red #40, flavors, glycerin, high fructose corn syrup, microcrystalline cellulose, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium chloride, sodium citrate dihydrate, sorbitol, sucralose, xanthan gum
Questions Or Comments?
1-800-426-9391
Principal Display
♥CVSHealth®
NDC 51316-500-19
MAXIMUM STRENGTH
COUGH &
CONGESTION
DEXTROMETHORPHAN HBr
Cough Suppressant
GUAIFENESIN
Expectorant
Oral Solution
SYMPTOM RELIEF
Controls cough
Relieves chest
congestion & mucus
For Ages 12 & Over
Compare to the active ingredients
in Robitussin® Maximum Strength
Cough + Chest Congestion DM†
8 FL OZ
(237 mL)
Menthol-Berry Flavor
♥CVSHealth®
You have quality
standards. So do we.
Keep your symptoms in
check with quality products
you can trust.
With our CVS Health® brand,
we perform ongoing tests
and monitor customer
feedback to help us exceed
your expectations.
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY
SEAL UNDER CAP IS BROKEN OR MISSING
Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
© 2024 CVS/pharmacy
CVS.com® 1-800-SHOP CVS V-19849
100% money back
guaranteed.
CVS.com/returnpolicy
†This product is not manufactured or distributed by
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC,
owner of the registered trademark Robitussin®
Maximum Strength Cough + Chest Congestion DM.
50844 ORG012303019
PARENTS:
Learn about teen medicine abuse
www.StopMedicineAbuse.org
Cvs 44-030 (Cvs 44 030 Cc 1)
* Please review the disclaimer below.
