Otc - Active Ingredient
: Each immediate-release tablet contains
Dextromethorphan HBr 20 mg Guaifenesin 400 mg
Mucosa Dm Tablet
FDA Label NDC 49483-280
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Time Cap Laboratories, Inc. for the product Mucosa Dm (NDC 49483-280). 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 otc - active ingredient, otc - purpose, otc - keep out of reach of children, indications & usage, warnings, dosage & administration, inactive ingredient, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Expectorant – Cough Suppressant
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
Indications & Usage
Helps loosen phlegm (mucus)
Helps thin bronchial secretions to make coughs more productive
Temporarily relieves cough due to minor throat and bronchial irritation associated with the common cold
Warnings
WARNINGS: 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.
Dosage & Administration
: Directions: Adults and children 12 years of age and older, take 1 tablet every 4 hours with a full glass of water while symptoms persist. Do not exceed 6 doses in 24 hours.
Children under 12 years of age do not use.
Inactive Ingredient
Colloidal Silicon Dioxide, Magnesium Stearate, Maltodextrin, Microcrystalline Cellulose, Povidone, Silicon Dioxide, Sodium Starch Glycolate, Stearic Acid
Package Label.Principal Display Panel
280rlabel (280r60lable)
* Please review the disclaimer below.
