Active Ingredient
(in each extended-release tablet)
Guaifenesin USP 600 mg
Guaifenesin Tablet, Extended Release
FDA Label NDC 58602-810
15 label sections · Submitted to the FDA by Aurohealth Llc · 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 58602-810). 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
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 or 2 extended-release tablets every 12 hours. Do not exceed 4 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 - 600 Mg (20 Tablet Label)
AUROHEALTH
NDC 58602-810-73
Guaifenesin
Extended-Release
Tablets 600 mg
Guaifenesin 600 mg- Expectorant
RELIEVES CHEST CONGESTION
12
HOUR
- Relieves Chest Congestion
- Thins & 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 Carton Label)
AUROHEALTH
NDC 58602-810-73
Compare to the active
ingredient in Mucinex®*
Guaifenesin Package Label-principal Display Panel (600 mg (20 Tablet Carton Label))
Extended-Release Tablets 600 mg
Guaifenesin 600 mg - Expectorant
RELIEVES CHEST CONGESTION
•Relieves Chest Congestion
•Thins & Loosens Mucus
12
HOUR
Actual size
20 Extended-Release
Tablets 
Package Label-Principal Display Panel - 600 Mg Blister Carton (20 (1 X 20) Tablets)
AUROHEALTH
NDC 58602-810-96
Compare to the active
ingredient in Mucinex®*
Guaifenesin
Extended-Release Tablets 600 mg
Guaifenesin 600 mg - Expectorant
RELIEVES CHEST CONGESTION
•Relieves Chest Congestion
•Thins & Loosens Mucus
Actual size
20
Extended-Release Tablets
12
HOUR
Package Label-principal Display Panel (600 mg Blister Carton (20 (1 x 20) Tablets))
* Please review the disclaimer below.
