EXPECTORANT TAB DM- dextromethorphan hydrobromide and 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 ingredients (in each tablet)

Dextromethorphan HBr 20 mg

Guaifenesin 400 mg

Purpose

Cough suppressant

Expectorant

Uses

  • helps loosen phlegm (mucus)
  • helps thin bronchial secretions to make coughs more productive
  • temporarily relieves cough due to minor throat and bronchial irritation associated with the common cold

Warnings

Do not use if you are now taking

a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have

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

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 for 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 20 mg LOW SODIUM
  • store at controlled room temperature 15°-30°C (59°-86°F)
  • keep in a dry place and do not expose to excessive heat
  • 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.

Package/Label Principal Display Panel

Expectorant Tab DM

Immediate release tablets

400 mg Guaifenesin and 20 mg Dextromethorphan HBr

  • Relieves congestion
  • controls cough

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

Proudly distributed by Western Family Foods, Inc.,

PO Box 4057, Portland, OR 97208 USA

Questions or comments? Call toll free 1-877-753-3935

Product Label

Western Family guaifenesin DM tablets

Expectorant Tab DM

EXPECTORANT TAB DM 
dextromethorphan hydrobromide and guaifenesin tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55312-109
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE20 mg
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN400 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE 
MAGNESIUM STEARATE 
MALTODEXTRIN 
CELLULOSE, MICROCRYSTALLINE 
POVIDONES 
SODIUM STARCH GLYCOLATE TYPE A POTATO 
STEARIC ACID 
Product Characteristics
ColorWHITEScore2 pieces
ShapeOVALSize15mm
FlavorImprint Code TCL;280;G2;G2
Contains    
Packaging
#Item CodePackage Description
1NDC:55312-109-301 in 1 BOX
130 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34107/05/2010
Labeler - Western Family Foods, Inc. (192166072)

Revised: 10/2012
Document Id: 4b4ff0d6-d4ba-4d33-873f-3cdce26efeb5
Set id: bbb30a13-6b77-41f2-9a61-4660c7bc688d
Version: 2
Effective Time: 20121010
 
Western Family Foods, Inc.