Mucinex Dm
FDA Label NDC 54868-6106

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Physicians Total Care, Inc. for the product Mucinex Dm (NDC 54868-6106). 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 uses, directions, other information, inactive ingredients, principal display panel - 1200 mg carton, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Uses

  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
  • temporarily relieves:
    • cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
    • the intensity of coughing
    • the impulse to cough to help you get to sleep

Directions

  • do not crush, chew, or break tablet
  • take with a full glass of water
  • this product can be administered without regard for timing of meals
  • adults and children 12 years and older: 1 tablet every 12 hours; not more than 2 tablets in 24 hours
  • children under 12 years of age: do not use

Other Information

  • tamper evident: do not use if carton is open or if printed seal on blister is broken or missing
  • store at 20-25°C (68-77°F)

Inactive Ingredients

carbomer 934P, NF; D&C yellow #10 aluminum lake; hypromellose, USP; magnesium stearate, NF; microcrystalline cellulose, NF; sodium starch glycolate, NF

Principal Display Panel - 1200 Mg Carton

MAXIMUM STRENGTH

NDC 54868-6106-0

Mucinex®DM

1200 mg guaifenesin & 60 mg dextromethorphan HBr
extended-release bi-layer tablets

EXPECTORANT & COUGH SUPPRESSANT

12 HOUR

NEW LOOK-
SAME RELIEF

Thins And Loosens Mucus

Controls Cough

14 EXTENDED-RELEASE BI-LAYER TABLETS

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