Mucinex Tablet, Extended Release
FDA Label NDC 55154-4680

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Cardinal Health 107, Llc for the product Mucinex (NDC 55154-4680). 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 bi-layer 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

* The name MUCINEX® and associated trademarked items are used with permission by Reckitt Benckiser

The drug product contained in this package is from NDC # 63824-008 Reckitt Benckiser.

Packaged and Distributed by American Health Packaging, 2550 John Glenn Avenue, Suite A, Columbus, OH 43217

Americanhealthpackaging.com

An AmerisourceBergen Company

Repackaged By:
Cardinal Health

Zanesville, OH 43701

057201
5500408/0915

L5315882-10617

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

Guaifenesin 600 mg

Purpose

Expectorant

12 Hour

Unique Bi-Layer Tablet

White Layer – Immediate Release Layer

Blue Layer – Extended-Release Layer

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.

This Unit Dose package is not child resistant and is Intended for Institutional Use Only. KEEP THIS AND ALL DRUGS OUT OF REACH OF CHILDREN.

If dispensed for outpatient use, a child-resistant container should be utilized.

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

  • FOR YOUR PROTECTION: Do not use if blister is torn or broken.
  • store between 20-25°C (68-77°F)

Inactive Ingredients

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

Questions?

1-866-MUCINEX (1-866-682-4639) for information about the drug product or to report side effects. For information about packaging, contact American Health Packaging at 1-800-707-4621.

Principal Display Panel

Mucinex 600 mg

Guaifenesin

EXPECTORANT

10 Extended-Release Bi-Layer Tablets

Bag Label (Image 01)

Bag Label (Image 01)

* Please review the disclaimer below.