EXPECTORANT- guaifenesin tablet 
Western Family Foods, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Active Ingredient (in each tablet)

Guaifenesin 400 mg

Purpose

Expectorant

Uses

  • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive to rid the bronchial passageway of bothersome mucus

Warnings

Ask a doctor before use if you have

  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema 
  • cough accompanied with excessive phlegm (mucus)

When using this product

  •  do not exceed recommended dosage
  • do not use for more than 7 days

Stop use and ask a doctor if

  • cough lasts more than 7 days, recurs, or is accompanied with fever, rash, or persistent headache. These could be signs of a serious condition.

If pregnant or breast-feeding,

 ask a health care professional before use.

Keep out of reach of children.

 In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

  • adults and children 12 years of age and older: take 1 tablet every 4 hours with a full glass of water while symptoms persist. Do not exceed 6 doses in 24 hours.
  • children under 12 years of age: do not use 

Other information

  • each tablet contains: sodium 5 mg VERY LOW SODIUM
  • store at controlled room temperature 15º-30ºC (59º-86ºF)
  • do not use if imprinted safety seal under cap is broken or missing

Inactive ingredients

colloidal silicon dioxide, magnesium stearate, maltodextrin, microcrystalline cellulose, povidone, sodium starch glycolate and stearic acid

Questions or Comments?

Call toll free: 1-877-753-3935

Principal Display Panel

EXPECTORANT

Immediate Release tablets

400 mg Guaifenesin

  • Relieves chest congestion
  • Thins and loosens mucus

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

Proudly Distributed by Western Family Foods, Inc.

P.O Box 4057, Portland, OR 97208 USA

Product Label

Western Family Expectorant tablets

Guaifenesin 400 mg

EXPECTORANT 
guaifenesin tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55312-107
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN400 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE 
MAGNESIUM STEARATE 
MALTODEXTRIN 
CELLULOSE, MICROCRYSTALLINE 
POVIDONES 
SODIUM STARCH GLYCOLATE TYPE A CORN 
STEARIC ACID 
Product Characteristics
ColorWHITEScore2 pieces
ShapeROUNDSize13mm
FlavorImprint Code TCL272;G1
Contains    
Packaging
#Item CodePackage Description
1NDC:55312-107-301 in 1 BOX
130 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34107/01/2010
Labeler - Western Family Foods, Inc. (192166072)

Revised: 10/2012
Document Id: 497965ec-53a6-44e9-b3a4-903702729a5e
Set id: 0fbd2d8b-f735-47b0-b5a6-dfb313b1822e
Version: 2
Effective Time: 20121010
 
Western Family Foods, Inc.