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

----------

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

Other information

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

PRINCIPAL DISPLAY PANEL - 1200 mg Tablet Blister Pack Carton

Compare to Maximum Strength
Mucinex® active ingredient*

NDC 68196-072-56

Member's Mark™

12
HOUR

Maximum Strength

Mucus Relief
Guaifenesin 1200 mg
Extended-Release Tablets,
Expectorant

actual size

56
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:68196-072
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:68196-072-564 in 1 CARTON10/31/2017
114 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02128210/31/2017
Labeler - SAM'S WEST INC (051957769)
Establishment
NameAddressID/FEIBusiness Operations
RECKITT BENCKISER HEALTHCARE INTERNATIONAL LTD230780363MANUFACTURE(68196-072) , LABEL(68196-072)

Revised: 11/2018
Document Id: 4c4c6cdb-d31b-4f1c-abc0-678278a1f078
Set id: f363cd68-ef6c-4de3-8e9d-2ae4a4fc2fda
Version: 5
Effective Time: 20181115
 
SAM'S WEST INC