Mucus
FDA Label NDC 46122-417

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Amerisourcebergen Drug Corporation for the product Mucus (NDC 46122-417). 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 other, active ingredient (in each extended-release tablet), purpose, uses, do not use, ask a doctor before use if you have, stop use and ask a doctor if, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Distributed By:
AmerisourceBergen,
1300 Morris Drive
Chesterbrook, PA 19087

Active Ingredient (In Each Extended-Release Tablet)

Guaifenesin 1200 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

Do Not Use

  • for children under 12 years of age

Ask A Doctor Before Use If You Have

  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
  • cough accompanied by too much phlegm (mucus)

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 illness.

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use.

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 (1-800-222-1222).

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 tablet every 12 hours. Do not exceed 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 between 20-25°C (68-77°F)

Inactive Ingredients

carbomer homopolymer type B; hypromellose, USP; magnesium stearate, NF; microcrystalline cellulose, NF; sodium starch glycolate, NF

Questions?

(1-800-406-7984)

You may also report side effects to this phone number.

Principal Display Panel - 1200 Mg Tablet Blister Pack Carton

NDC 46122-417-74

Compare to active ingredient in
Maximum Strength Mucinex® †

GOOD
NEIGHBOR
PHARMACY®

12 HOUR

Maximum Strength

Mucus • ER

Guaifenesin Extended-Release
Tablets, 1200 mg

Expectorant

  • Relieves Chest Congestion
  • Thins and Loosens Mucus
  • Immediate and Extended Release

    • 14 Extended-Release Tablets

    Principal Display Panel (1200 mg Tablet Blister Pack Carton)

    Principal Display Panel (1200 mg Tablet Blister Pack Carton)

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