12 HOUR MUCUS RELIEF- guaifenesin tablet, extended release

12 Hour Mucus Relief by

Drug Labeling and Warnings

12 Hour Mucus Relief by is a Otc medication manufactured, distributed, or labeled by CHAIN DRUG MARKETING ASSOCIATION INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each extended-release tablet)

Guaifenesin 600 mg

Purpose

Expectorant

Uses

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

WARNINGS

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).

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

Other information

■ store between 20-25ºC (68-77ºF)

■ retain carton for complete product information and warnings

Inactive ingredients

carbomer homopolymer type B, hypromellose, magnesium stearate, microcrystalline cellulose, sodium starch glycolate

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

INGREDIENTS AND APPEARANCE

12 HOUR MUCUS RELIEF 
guaifenesin tablet, extended release

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63868-149
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	600 mg

Inactive Ingredients
Ingredient Name	Strength
CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED) (UNII: Z135WT9208)
HYPROMELLOSE 2910 (15 MPA.S) (UNII: 36SFW2JZ0W)
SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)

Product Characteristics
Color	white	Score	no score
Shape	OVAL	Size	16mm
Flavor		Imprint Code	G;600
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63868-149-20	2 in 1 CARTON	09/17/2021	11/30/2026
1		10 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA213420	09/17/2021	11/30/2026

Labeler - CHAIN DRUG MARKETING ASSOCIATION INC (011920774)