Active Ingredients
(in each extended-release tablet)
Guaifenesin USP 1200 mg
Pseudoephedrine HCl USP 120 mg
Guaifenesin And Pseudoephedrine Hcl Tablet, Extended Release
FDA Label NDC 58602-834
14 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 And Pseudoephedrine Hcl (NDC 58602-834). 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, purposes, uses, warnings, ask a doctor before use if you have, when using this product, stop use and ask a doctor if, if pregnant or breast-feeding,, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purposes
Expectorant
Nasal Decongestant
Uses
- helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
- temporarily relieves nasal congestion due to
- common cold
- hay fever
- upper respiratory allergies
- temporarily restores freer breathing through the nose
- promotes nasal and/or sinus drainage
- temporarily relieves sinus congestion and pressure
Warnings
- Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
Ask A Doctor Before Use If You Have
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- trouble urinating due to an enlarged prostate gland
- persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
- cough accompanied by too much phlegm (mucus)
When Using This Product
- do not use more than directed
Stop Use And Ask A Doctor If
- you get nervous, dizzy, or sleepless
- symptoms do not get better within 7 days, come back or occur with a 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 timing of meals
- adults and children 12 years and older: 1 extended-release tablet every 12 hours; not more than 2 extended-release tablets in 24 hours
- children under 12 years of age: do not use
Other Information
- store at 20 to 25°C (68 to 77°F)
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)
Distributed by:
AUROHEALTH LLC
279 Princeton-Hightstown Road
East Windsor, NJ 08520
Made in India
Code: AP/DRUGS/04/2016
Package Label-Principal Display Panel - 1200 Mg/120 Mg (12 Tablet Carton Label)
AUROHEALTH
NDC 58602-834-77
*Compare to the active
ingredients of Mucinex®D
MAXIMUM STRENGTH
Guaifenesin and
Pseudoephedrine Hydrochloride
Extended-Release Tablets
1200 mg/120 mg
Guaifenesin 1200 mg - Expectorant
Pseudoephedrine HCl 120 mg - Nasal Decongestant
RELIEVES NASAL & CHEST CONGESTION
12 HOUR Package Label-principal Display Panel (1200 mg/120 mg (12 Tablet Carton Label))
• Clears Nasal & Sinus Congestion
• Thins & Loosens Mucus
12 Extended-Release Tablets 
* Please review the disclaimer below.
