GUAIFENESIN EXTENDED RELEASE- guaifenesin tablet, extended release 
CVS PHARMACY

----------

GUAIFENESIN EXTENDED-RELEASE TABLETS, 1200 mg 14ct and 28ct

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: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895

PRINCIPAL DISPLAY PANEL - 1200 mg Tablet Blister Pack Carton

CVS
Health™

Compare to the active ingredient in
Maximum Strength Mucinex®*

MAXIMUM STRENGTH

Mucus
Extended
Release

12
HOUR

GUAIFENESIN EXTENDED-RELEASE
TABLETS, 1200 mg

EXPECTORANT

•
Relieves chest congestion
•
Thins and loosens mucus
•
Immediate and extended release

Actual Size

28 EXTENDED-
RELEASE TABLETS

PRINCIPAL DISPLAY PANEL - 1200 mg Tablet Blister Pack Carton
GUAIFENESIN  EXTENDED RELEASE
guaifenesin tablet, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-016
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Guaifenesin (UNII: 495W7451VQ) (Guaifenesin - UNII:495W7451VQ) Guaifenesin1200 mg
Inactive Ingredients
Ingredient NameStrength
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31)  
hypromellose, unspecified (UNII: 3NXW29V3WO)  
magnesium stearate (UNII: 70097M6I30)  
microcrystalline cellulose (UNII: OP1R32D61U)  
sodium starch glycolate type A potato (UNII: 5856J3G2A2)  
Product Characteristics
ColorWHITEScoreno score
ShapeOVALSize22mm
FlavorImprint Code Mxeunic;1200
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69842-016-141 in 1 CARTON08/21/2017
114 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:69842-016-282 in 1 CARTON08/21/2017
214 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02128208/21/2017
Labeler - CVS PHARMACY (062312574)
Establishment
NameAddressID/FEIBusiness Operations
RECKITT BENCKISER HEALTHCARE INTERNATIONAL LTD230780363MANUFACTURE(69842-016) , LABEL(69842-016)

Revised: 11/2018
Document Id: b4ea3a57-e79c-40a2-83cc-01e40a7eac82
Set id: 2c75f0cf-158d-4f68-955b-c2fc11192789
Version: 3
Effective Time: 20181103
 
CVS PHARMACY