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Guaifenesin Extended Release by SAM'S WEST INC

Medically reviewed on June 25, 2018

Dosage form: tablet, extended release
Ingredients: Guaifenesin 1200mg
Labeler: SAM'S WEST INC
NDC Code: 68196-072

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:
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

  • Relieves chest
    congestion
  • Thins and
    loosens mucus
  • Immediate and
    Extended Release

actual size

56
Extended-
Release
Tablets

GUAIFENESIN   EXTENDED RELEASE
guaifenesin tablet, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68196-072
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:68196-072-564 BLISTER PACK in 1 CARTON
114 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02128210/31/2017
Labeler - SAM'S WEST INC (051957769)
Establishment
NameAddressID/FEIOperations
RECKITT BENCKISER HEALTHCARE INTERNATIONAL LTD230780363MANUFACTURE(68196-072), LABEL(68196-072)

 
SAM'S WEST INC

← See all Guaifenesin Extended Release brands

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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