12 HOUR MUCUS RELIEF- guaifenesin tablet, extended release 
CHAIN DRUG MARKETING ASSOCIATION INC

----------

1203A-QCH-2021-1108

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

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

image description

12 HOUR MUCUS RELIEF 
guaifenesin tablet, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-149
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN600 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorwhiteScoreno score
ShapeOVALSize16mm
FlavorImprint Code G;600
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63868-149-202 in 1 CARTON09/17/2021
110 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21342009/17/2021
Labeler - CHAIN DRUG MARKETING ASSOCIATION INC (011920774)

Revised: 11/2021
Document Id: d07197cb-9b4f-82f5-e053-2995a90a1e3b
Set id: 0d3b8e23-90d2-431b-a395-a9ddf2457e64
Version: 2
Effective Time: 20211110
 
CHAIN DRUG MARKETING ASSOCIATION INC