Guaifenesin and Pseudoephedrine HCl GUAIFENESIN AND PSEUDOEPHEDRINE HCL AUROHEALTH LLC FDA Approved 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
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Substance Guaifenesin
Route
ORAL
Applications
ANDA213203

Drug Facts

Composition & Profile

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).
Strengths
1200 mg 120 mg
Quantities
12 tablet
Treats Conditions
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
Pill Appearance
Shape: capsule Color: white Imprint: 65;X

Identifiers & Packaging

Container Type BOX
UNII
495W7451VQ 6V9V2RYJ8N
Packaging

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 PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1200 mg/120 mg (12 Tablet Carton Label)

Package Descriptions
  • 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 PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1200 mg/120 mg (12 Tablet Carton Label)

Overview

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

Indications & Usage

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

Dosage & Administration

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

Warnings & Precautions
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.
Purpose

Purposes Expectorant Nasal Decongestant

When Using

When using this product do not use more than directed

Stop Use & Ask a Doctor

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

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).

Storage & Handling

Other information store at 20 to 25°C (68 to 77°F)

Questions

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


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