Mucinex
FDA Label NDC 53808-0871

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by State Of Florida Doh Central Pharmacy for the product Mucinex (NDC 53808-0871). 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 ingredient (in each extended-release bi-layer tablet), purpose, uses, directions, other information, inactive ingredients, keep out of reach of children, package label, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient (In Each Extended-Release Bi-Layer Tablet)

Guaifenesin 600 mg

Purpose

Expectorant

Uses

helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

Directions

  • do not crush, chew, or break tablet
  • take with a full glass of water
  • this product can be administered without regard for the timing of meals
  • adults and children 12 years of age and over: 1 or 2 tablets every 12 hours. Do not exceed 4 tablets in 24 hours.
  • children under 12 years of age: do not use

Other Information

  • store between 20-25°C (68-77°F)
  • see window for lot number and expiration date

    • Questions? 1-866-MUCINEX (1-866-682-4639)

    You may also report side effects to this phone number

    Please visit our web site www.mucinex.com

    US Pat. 6,372,252 B1

    US Pat. 6,955,821 B2

Inactive Ingredients

carbomer homopolymer type B, FD&C blue #1 aluminum lake; hypromellose, USP; magnesium stearate, NF; microcrystalline cellulose, NF; sodium starch glycolate, NF

Keep Out Of Reach Of Children

Keep out of reach of children. This package is intended for institutional use only. This package is not child resistant. In case of overdose, get medical help or contact a Poison Control Center right away.

Package Label

Label Image for 53808-0871
600mg

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