Active Ingredients (In Each Caplet)
Dextromethorphan HBr 20 mg
Guaifenesin 400 mg
Mucus Relief Cough And Congestion Dm Tablet
FDA Label NDC 71335-1928
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Bryant Ranch Prepack for the product Mucus Relief Cough And Congestion Dm (NDC 71335-1928). 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 caplet), 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
Expectorant
Uses
- temporarily relieves cough due to minor throat and bronchial irritation associated with the common cold
- helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
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 accompanied by too much phlegm (mucus)
- persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, 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, comes back, or occurs with 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
- take with a full glass of water
- adults and children 12 years of age and over: 1 tablet every 4 hours. Do not take more than 6 tablets in 24 hours.
- children under 12 years: do not use
Other Information
- store at 15°-30°C (59°-86°F)
Inactive Ingredients
Colloidal silicon dioxide, magnesium stearate, maltodextrin, microcrystalline cellulose, povidone, stearic acid
Questions Or Comments?
call 804-270-4498, 8.30 am-4.30 pm ET, Monday - Friday
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
How Supplied
NDC: 71335-1928-1: 30 Tablets in a BOTTLE
NDC: 71335-1928-2: 20 Tablets in a BOTTLE
NDC: 71335-1928-3: 18 Tablets in a BOTTLE
Package Label.Principal Display Panel
Guaifenesin/DM 400/20mg Tablet
Label (Lbl713351928)
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