Guaifenesin Tablet, Extended Release
FDA Label NDC 76162-031

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Topco Associates Llc for the product Guaifenesin (NDC 76162-031). 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 TOPCO ASSOCIATES LLC
ITASCA, IL 60143 ©TOPCO ARHA0825
QUESTIONS? 1-888-423-0139
[email protected] www.topcarebrand.com

MADE IN INDIA

Package Label-Principal Display Panel - 1200 Mg Blister Carton (56 (4 X14) Tablets)

Topcare®
health

 NDC 76162-031-56

COMPARE TO THE ACTIVE INGREDIENT
IN MAXIMUM STRENGTH MUCINEX®*

MAXIMUM STRENGTH

Mucus ER
GUAIFENESIN
EXTENDED-RELEASE TABLETS 1200 mg

GUAIFENESIN 1200 mg - EXPECTORANT
RELIEVES CHEST CONGESTION

12
HOUR

For Day or Night

  • Relieves Chest Congestion
  • Thins & Loosens Mucus

    • 56
    EXTENDED-RELEASE TABLETS

     

     

    Package Label-principal Display Panel (1200 mg Blister Carton (14 (1 x14) Tablets))

    Package Label-principal Display Panel (1200 mg Blister Carton (14 (1 x14) Tablets))

* Please review the disclaimer below.