GUAIFENESIN EXTENDED RELEASE- guaifenesin tablet, extended release 
SAM'S WEST INC

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Guaifenesin
Extended Release

Drug Facts

Active ingredient (in each extended-release tablet)

Guaifenesin, USP 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 extended-release 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 extended-release tablet every 12 hours. Do not exceed 2 extended-release tablets in 24 hours.
children under 12 years of age: do not use

Other information

store between 20-25°C (68-77°F)
TAMPER EVIDENT: DO NOT USE IF CARTON IS OPEN OR IF PRINTED SEAL ON BLISTER IS BROKEN OR MISSING.

Inactive ingredients

colloidal silicon dioxide, FD&C blue #2 aluminum lake, hypromellose, magnesium stearate, povidone.

Questions?

call toll-free Monday to Friday 8:30 am to 5:00 pm EST at 1-800-406-7984.

DISTRIBUTED BY:
SAM'S WEST, INC.
BENTONVILLE, AR 72716

PRINCIPAL DISPLAY PANEL - 1200 mg Tablet Blister Pack Carton

Compare to Maximum Strength Mucinex®
active ingredient*

NDC 68196-996-56

Member's Mark

Maximum Strength

Mucus Relief

Guaifenesin Extended-Release
Tablets, 1200 mg
Expectorant

Relieves chest congestion
Thins and loosens mucus

12
HOUR

56
Extended-
Release
Tablets

guaifenesin-01
GUAIFENESIN  EXTENDED RELEASE
guaifenesin tablet, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68196-996
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Guaifenesin (UNII: 495W7451VQ) (Guaifenesin - UNII:495W7451VQ) Guaifenesin1200 mg
Inactive Ingredients
Ingredient NameStrength
hypromellose, unspecified (UNII: 3NXW29V3WO)  
magnesium stearate (UNII: 70097M6I30)  
silicon dioxide (UNII: ETJ7Z6XBU4)  
povidone, unspecified (UNII: FZ989GH94E)  
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
Product Characteristics
ColorWHITEScoreno score
ShapeOVALSize22mm
FlavorImprint Code RH;99
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68196-996-564 in 1 CARTON01/12/2022
114 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20925401/12/2022
Labeler - SAM'S WEST INC (051957769)
Establishment
NameAddressID/FEIBusiness Operations
Ohm Laboratories Inc.184769029MANUFACTURE(68196-996)

Revised: 6/2022
Document Id: 1cb900ed-18b4-4999-a149-0b4667abcda1
Set id: 64297bb8-cd4e-46d3-ae79-ea4aa4c03bca
Version: 4
Effective Time: 20220624
 
SAM'S WEST INC