drug facts
2f622f57-4de0-44a9-a21f-c98260574f1e
34390-5
Human OTC Drug Label
Drug Facts
Composition & Product
Identifiers & Packaging
Purpose
Expectorant Nasal Decongestant
Description
(in each extended-release tablet) Guaifenesin USP 1200 mg Pseudoephedrine HCl USP 120 mg
Medication Information
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.
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
Purpose
Expectorant Nasal Decongestant
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).
Description
(in each extended-release tablet) Guaifenesin USP 1200 mg Pseudoephedrine HCl USP 120 mg
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
Purposes
Expectorant
Nasal Decongestant
Active Ingredients
(in each extended-release tablet)
Guaifenesin USP 1200 mg
Pseudoephedrine HCl USP 120 mg
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).
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)
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
• Clears Nasal & Sinus Congestion
• Thins & Loosens Mucus
12 Extended-Release Tablets
Structured Label Content
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.
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
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 (Other information)
- store at 20 to 25°C (68 to 77°F)
Inactive Ingredients (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
Purposes
Expectorant
Nasal Decongestant
Active Ingredients (Active ingredients)
(in each extended-release tablet)
Guaifenesin USP 1200 mg
Pseudoephedrine HCl USP 120 mg
When Using This Product (When using this product)
- do not use more than directed
Stop Use and Ask A Doctor If (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, (If pregnant or breast-feeding,)
ask a health professional before use
Keep Out of Reach of Children. (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).
Ask A Doctor Before Use If You Have (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)
Package Label Principal Display Panel 1200 Mg/120 Mg (12 Tablet Carton Label) (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
• Clears Nasal & Sinus Congestion
• Thins & Loosens Mucus
12 Extended-Release Tablets
Advanced Ingredient Data
Raw Label Data
All Sections (JSON)
Additional Information
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Source: dailymed · Ingested: 2026-02-15T12:03:32.375620 · Updated: 2026-03-14T23:03:40.356549