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Guaifenesin Extended Release by CHAIN DRUG MARKETING ASSOCIATION INC

Dosage form: tablet, extended release
Ingredients: Guaifenesin 1200mg
Labeler: CHAIN DRUG MARKETING ASSOCIATION INC
NDC Code: 63868-390

Guaifenesin Extended-Release Tablets 1200 mg

Drug Facts

Active ingredient (in each extended-release tablet)

Guaifenesin 1200 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 tablet every 12 hours. Do not exceed 2 tablets in 24 hours.
children under 12 years of age: do not use

Other information
Tamper evident: Do not use if carton is open or if printed seal on blister is broken or missing.
store between 20-25°C (68-77°F)

Inactive ingredients

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

Questions?

(1-800-406-7984)

You may also report side effects to this phone number.

Distributed by C.D.M.A., Inc.©
43157 W. Nine Mile
Novi, MI 48375

PRINCIPAL DISPLAY PANEL - 1200 mg Tablet Blister Pack Carton

NDC 63868-390-14

QC®
QUALITY
CHOICE

Compare to
Active Ingredient in
Maximum Strength
Mucinex®

Maximum Strength

Mucus Relief

Guaifenesin
Extended-Release
Tablets 1200 mg

Expectorant

12 Hour

Relieves Chest Congestion
Thins and Loosens Mucus
Immediate and Extended Release

14 Extended-Release Tablets

GUAIFENESIN  EXTENDED RELEASE
guaifenesin tablet, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-390
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Guaifenesin (Guaifenesin) Guaifenesin1200 mg
Inactive Ingredients
Ingredient NameStrength
carbomer homopolymer type B (allyl pentaerythritol or allyl sucrose crosslinked) 
hypromellose, unspecified 
magnesium stearate 
microcrystalline cellulose 
SODIUM STARCH GLYCOLATE TYPE A POTATO 
Product Characteristics
ColorWHITEScoreno score
ShapeOVALSize16mm
FlavorImprint CodeMucinex;1200
Contains    
Packaging
#Item CodePackage Description
1NDC:63868-390-141 BLISTER PACK in 1 CARTON
114 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
2NDC:63868-390-282 BLISTER PACK in 1 CARTON
214 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02128210/15/2017
Labeler - CHAIN DRUG MARKETING ASSOCIATION INC (011920774)
Establishment
NameAddressID/FEIOperations
RECKITT BENCKISER HEALTHCARE INTERNATIONAL LTD230780363MANUFACTURE(63868-390)

Revised: 10/2017
 
CHAIN DRUG MARKETING ASSOCIATION INC

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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