Guaifenesin Tablet, Extended Release
FDA Label NDC 58602-853

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 58602-853). 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 ingredients, 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 Ingredients

(in each extended-release tablet)
 Guaifenesin USP 600 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 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

  • store between 20° to 25°C (68° to 77°F)
  • Tamper evident: Do not use if carton is open or if 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:
Aurohealth LLC.
2572 Brunswick Pike,
Lawrenceville, NJ 08648

Code: AP/DRUGS/04/2016

Made in India

Package Label-Principal Display Panel - 600 Mg (20 Tablet Label)

Healthy Living™

NDC 58602-853-73

Guaifenesin
Extended-Release Tablets 600 mg

EXPECTORANT 

12 HOUR

  • Relieves Chest Congestion
  • Thins And Loosens Mucus

    • 20 
    Extended-Release
    Tablets

    Package Label-principal Display Panel (600 mg (20 Tablet Label))

    Package Label-principal Display Panel (600 mg (20 Tablet Label))



Package Label-Principal Display Panel - 600 Mg (20 Tablet Carton Label)

Healthy Living™
 

NDC 58602-853-73

Compare to the active
ingredient in Mucinex®*

Guaifenesin
Extended-release Tablets 600 mg

EXPECTORANT
 
•Relieves Chest Congestion
•Thins And Loosens Mucus

12 HOUR 

 20
Extended-Release
Tablets

Package Label-principal Display Panel (600 mg (20 Tablet Carton Label))

Package Label-principal Display Panel (600 mg (20 Tablet Carton Label))


Package Label-Principal Display Panel - 600 Mg Blister Carton (20 (1 X 20) Tablets)

Healthy Living™
 

NDC 58602-853-96

Compare to the active
ingredient in Mucinex®*

Guaifenesin
Extended-release Tablets 600 mg

EXPECTORANT
 
•Relieves Chest Congestion
•Thins And Loosens Mucus

12 HOUR 

20
Extended-Release
Tablets

Package Label-principal Display Panel (600 mg Blister Carton (20 (1 x 20) Tablets))

Package Label-principal Display Panel (600 mg Blister Carton (20 (1 x 20) Tablets))

* Please review the disclaimer below.