Drug Facts

Drug Facts
SPL v4
SPL
SPL Set ID 2f622f57-4de0-44a9-a21f-c98260574f1e
Route
ORAL
Published
Effective Date 2024-09-03
Document Type 34390-5 Human OTC Drug Label

Drug Facts

Composition & Product

Active Ingredients
Guaifenesin (1200 mg) Pseudoephedrine (120 mg)
Inactive Ingredients
Silicon Dioxide Hypromellose 2208 (15000 Mpa.s) Magnesium Stearate Microcrystalline Cellulose 101 Microcrystalline Cellulose 102 Povidone K25 Povidone K90 Starch, Corn

Identifiers & Packaging

Pill Appearance
Imprint: 65;X Shape: capsule Color: white Size: 22 mm Score: 1
Marketing Status
ANDA Active Since 2020-03-25

Description

(in each extended-release tablet)      Guaifenesin USP 1200 mg                                                                                       Pseudoephedrine HCl USP 120 mg                                                                        

Purpose

Expectorant Nasal Decongestant


Medication Information

Purpose

Expectorant Nasal Decongestant

Description

(in each extended-release tablet)      Guaifenesin USP 1200 mg                                                                                       Pseudoephedrine HCl USP 120 mg                                                                        

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
Purposes

Expectorant

Nasal Decongestant

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.
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
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

Other Information
  • store at 20 to 25°C (68 to 77°F)
Active Ingredients

(in each extended-release tablet)     



Guaifenesin USP 1200 mg                                                                                      

Pseudoephedrine HCl USP 120 mg                                                                        

Inactive Ingredients

colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, pregelatinised starch (maize).

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

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
Purposes

Expectorant

Nasal Decongestant

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.
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
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

Other Information (Other information)
  • store at 20 to 25°C (68 to 77°F)
Active Ingredients (Active ingredients)

(in each extended-release tablet)     



Guaifenesin USP 1200 mg                                                                                      

Pseudoephedrine HCl USP 120 mg                                                                        

Inactive Ingredients (Inactive ingredients)

colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, pregelatinised starch (maize).

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

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