Guaifenesin GUAIFENESIN 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
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Substance Guaifenesin
Route
ORAL
Applications
ANDA210453
Package NDC

Drug Facts

Composition & Profile

Active Ingredients
Active ingredient (in each extended-release tablet) Guaifenesin USP 600 mg
Inactive Ingredients
Inactive ingredients colloidal silicon dioxide hypromellose magnesium stearate microcrystalline cellulose povidone and pregelatinised starch (maize)
Strengths
600 mg
Quantities
20 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
Pill Appearance
Shape: oval Color: white Imprint: L;68

Identifiers & Packaging

Container Type BOX
All Product Codes
UNII
495W7451VQ
Packaging

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 600 mg Blister Carton (100 (5 x 20) Tablets) NDC 58602-864-98 PrimaryHealth COMPARE TO Mucinex ® Active Ingredient* Guaifenesin Extended-Release Tablets 600 mg Guaifenesin 600 mg – Expectorant RELIEVES CHEST CONGESTION Relieves Chest Congestion Thins & Loosens Mucus 12 HOUR Actual size 100 Extended-Release Tablets PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 600 mg (20 Tablet Label)

Package Descriptions
  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 600 mg Blister Carton (100 (5 x 20) Tablets) NDC 58602-864-98 PrimaryHealth COMPARE TO Mucinex ® Active Ingredient* Guaifenesin Extended-Release Tablets 600 mg Guaifenesin 600 mg – Expectorant RELIEVES CHEST CONGESTION Relieves Chest Congestion Thins & Loosens Mucus 12 HOUR Actual size 100 Extended-Release Tablets PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 600 mg (20 Tablet Label)

Overview

Uses helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

Indications & Usage

Uses helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

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 of age and over: 1 or 2 extended-release tablets every 12 hours. Do not exceed 4 extended-release tablets in 24 hours children under 12 years of age: do not use

Warnings & Precautions
Warnings Do not use for children under 12 years of age
Purpose

Purpose Expectorant

Stop Use & Ask a Doctor

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.

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 between 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


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