Guaifenesin Tablet, Extended Release
FDA Label NDC 0363-0033

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Walgreen Co. for the product Guaifenesin (NDC 0363-0033). 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 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

  • store between 20° to 25°C (68° to 77°F)
  • Tamper evident: Do not use if carton is open or if printed seal on blister is broken or missing

Inactive Ingredients


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

Questions?

1-855-274-4122 (Monday – Friday 8:30 AM to 5:00 PM EST) You may also report side effects to this phone number.

DISTRIBUTED BY: WALGREEN CO.
200 WILMOT RD., DEERFIELD, IL 60015
100% SATISFACTION GUARANTEED
Walgreens.com ©2019 Walgreen Co.

MADE IN INDIA

Code: AP/DRUGS/04/2016

Package Label-Principal Display Panel - 1200 Mg 14 (1 X 14) Tablets

Walgreens

Compare to Maximum Strength
Mucinex® active ingredient•

NDC 0363-0033-01

12 HOUR
Mucus Relief ER
GUAIFENESIN EXTENDED-RELEASE TABLETS
1200 MG / EXPECTORANT

MAXIMUM STRENGTH 12 HOUR

  • Relieves chest congestion
  • Thins and loosens mucus

    • 14                                                 69
    EXTENDED-RELEASE        ACTUAL SIZE
    TABLETS

    Package Label-principal Display Panel (1200 mg (20 Tablet Label))

    Package Label-principal Display Panel (1200 mg (20 Tablet Label))

     


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