GUAIFENESIN GUAIFENESIN SAM'S WEST INC 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 1200 mg
Inactive Ingredients
Inactive ingredients colloidal silicon dioxide hypromellose magnesium stearate microcrystalline cellulose povidone and pregelatinised starch (maize) Questions? 1-855-274-4122 (Monday – Friday 8:30 AM to 5:00 PM EST) DISTRIBUTED BY: SAM'S WEST INC. BENTONVILLE AR 72716 Made in India
Strengths
1200 mg
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;69

Identifiers & Packaging

Container Type BOX
All Product Codes
UNII
495W7451VQ
Packaging

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1200 mg Blister Carton (56 (4 x 14) Tablets) Member's Mark ™ COMPARE TO MAXIMUM STRENGTH MUCINEX ® ACTIVE INGREDIENT* NDC 68196-960-56 MAXIMUM STRENGTH Mucus Relief GUAIFENESIN EXTENDED-RELEASE TABLETS, 1200 mg GUAIFENESIN 1200 mg-EXPECTORANT Relieves chest congestion Actual Size 56 Extended-Release Tablets Relieves chest congestion Thins and loosens mucus 12 HR PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1200 mg Blister Carton (56 (4 x 14) Tablets)

Package Descriptions
  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1200 mg Blister Carton (56 (4 x 14) Tablets) Member's Mark ™ COMPARE TO MAXIMUM STRENGTH MUCINEX ® ACTIVE INGREDIENT* NDC 68196-960-56 MAXIMUM STRENGTH Mucus Relief GUAIFENESIN EXTENDED-RELEASE TABLETS, 1200 mg GUAIFENESIN 1200 mg-EXPECTORANT Relieves chest congestion Actual Size 56 Extended-Release Tablets Relieves chest congestion Thins and loosens mucus 12 HR PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1200 mg Blister Carton (56 (4 x 14) Tablets)

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 extended-release tablet every 12 hours. Do not exceed 2 extended-release tablets in 24 hours. children under 12 years of age: do not use

Warnings & Precautions
Warnings Do not use
Purpose

Purpose Expectorant

Do Not Use

for children under 12 years of age

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)


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