12 Hour Mucus Relief GUAIFENESIN CHAIN DRUG MARKETING ASSOCIATION 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
ANDA213420
Package NDC

Drug Facts

Composition & Profile

Active Ingredients
Active ingredient (in each extended-release tablet) Guaifenesin 600 mg
Inactive Ingredients
Inactive ingredients carbomer homopolymer type B hypromellose magnesium stearate microcrystalline cellulose sodium starch glycolate
Strengths
600 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: G;600

Identifiers & Packaging

Container Type UNKNOWN
All Product Codes
UNII
495W7451VQ
Packaging

PRINCIPAL DISPLAY PANEL QUALITY CHOICE® NDC 63868-149-20 †Compare to the Active Ingredient in MUCINEX® 12 Hour Mucus Relief Expectorant Guaifenesin Extended-Release Tablets, 600 mg • Relieves Chest Congestion • Thins & Loosens Mucus • Immediate and Extended Release Actual Size 20 EXTENDED-RELEASE TABLETS image description

Package Descriptions
  • PRINCIPAL DISPLAY PANEL QUALITY CHOICE® NDC 63868-149-20 †Compare to the Active Ingredient in MUCINEX® 12 Hour Mucus Relief Expectorant Guaifenesin Extended-Release Tablets, 600 mg • Relieves Chest Congestion • Thins & Loosens Mucus • Immediate and Extended Release Actual Size 20 EXTENDED-RELEASE TABLETS image description

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 tablet ■ take with a full glass of water ■ this product can be administered without regard for the timing of meals ■ adults and children 12 years of age and over: 1 or 2 tablets every 12 hours. Do not exceed 4 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 Ask a doctor before use if you have ■ persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema ■ cough accompanied by too much phlegm (mucus) 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. 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).
Purpose

Purpose Expectorant

Do Not Use

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 20-25ºC (68-77ºF) ■ retain carton for complete product information and warnings


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