Active Ingredients
(in each extended-release tablet)
Guaifenesin USP 1200 mg
Guaifenesin Tablet, Extended Release
FDA Label NDC 58602-811
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 58602-811). 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
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:
Aurohealth LLC.
2572 Brunswick Pike,
Lawrenceville, NJ 08648
Code: AP/DRUGS/04/2016
Made in India
Package Label-Principal Display Panel - 1200 Mg (20 Tablet Label)
AUROHEALTH
NDC 58602-811-73
MAXIMUM STRENGTH
Guaifenesin
Extended-Release
Tablets 1200 mg
EXPECTORANT
12 HOUR
- Relieves Chest Congestion
- Thins And Loosens Mucus
20
Extended-Release
Tablets
Package Label-principal Display Panel (1200 mg (20 Tablet Label))
Package Label-Principal Display Panel - 1200 Mg (20 Tablet Carton Label)
AUROHEALTH
NDC 58602-811-73
Compare to the active
Ingredient in Maximum
Strength Mucinex®*
MAXIMUM STRENGTH
Guaifenesin Extended-Release Tablets 1200 mg
EXPECTORANT
- Relieves Chest Congestion
- Thins And Loosens Mucus
12 HOUR
20
Extended-Release Tablets
Package Label-principal Display Panel (1200 mg (20 Tablet Carton Label))
Package Label-Principal Display Panel - 1200 Mg Blister Carton (14 (1 X 14) Tablets)
AUROHEALTH
NDC 58602-811-01
Compare to the active
Ingredient in Maximum
Strength Mucinex®*
MAXIMUM STRENGTH
Guaifenesin
Extended-Release Tablets 1200 mg
EXPECTORANT
- Relieves Chest Congestion
- Thins And Loosens Mucus
14
Extended-Release
Tablets
12 HOUR
Package Label-principal Display Panel (1200 mg Blister Carton (14 (1 x 14) Tablets))
* Please review the disclaimer below.
