Guaifenesin Tablet, Extended Release
FDA Label NDC 58602-857

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Aurohealth Llc for the product Guaifenesin (NDC 58602-857). 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, purpose, uses, warnings, ask a doctor before use if you have, stop use and ask a doctor if, if pregnant or breast-feeding,, keep out of reach of children., 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 tablet)

Guaifenesin USP 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

Warnings


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.

If Pregnant Or Breast-Feeding,


ask a health professional before use.

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 extended-release 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 extended-release tablet every 12 hours. Do not exceed 2 extended-release tablets in 24 hours
  • children under 12 years of age: do not use

Other Information

  • store between 20° to 25°C (68° to 77°F)

Inactive Ingredients


colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, and pregelatinised starch (maize)

Questions?

1-855-274-4122 (Monday – Friday 8:30 AM to 5:00 PM EST)


Distributed by:
AUROHEALTH LLC.
279 Princeton-Hightstown Road,
East Windsor, NJ 08520

Made in India

Package Label-Principal Display Panel - 1200 Mg Blister Carton (84 (6 X 14) Tablets)

Healthy Living™

Maximum Strength

GUAIFENESIN
extended-release tablets 1200 mg

Guaifenesin 1200 mg - Expectorant

RELIEVES CHEST CONGESTION

  • Relieves Chest Congestion
  • Thins & Loosens Mucus

    • 12 Hour

    *Compare
    to the Active
    Ingredient in
    Maximum
    Strength
    Mucinex®

    84 Extended-Release Tablets


















    Package Label-principal Display Panel (1200 mg Blister Carton (84 (6 x 14) Tablets))

    Package Label-principal Display Panel (1200 mg Blister Carton (84 (6 x 14) Tablets))

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