Tussin DM by Western Family Foods, Inc. Drug Facts

Tussin DM by

Drug Labeling and Warnings

Tussin DM by is a Otc medication manufactured, distributed, or labeled by Western Family Foods, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

TUSSIN DM ADULT- dextromethorphan hbr, guaifenesin liquid 
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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Drug Facts

Active ingredients (in each 10 mL)

Dextromethorphan HBr 20 mg

Guaifenesin 200 mg

Purposes

Cough suppressant

Expectorant

Uses

  • temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
  • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes

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 that occurs with too much phlegm (mucus)
  • cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema

Stop use and ask a doctor if

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

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 (1-800-222-1222) right away.

Directions

  • shake well before using
  • do not take more than 6 doses in any 24-hour period
  • measure only with the dosing cup provided
  • keep dosing cup with product
  • mL= milliliter
  • this adult product is not intended for use in children under 12 years of age
  • adults and children 12 years and over: 10 mL every 4 hours
  • children under 12 years: do not use

Other information

  • store betwen 20-25ºC(68-77ºF). Do not refrigerate.

Inactive ingredients

anhydrous citric acid, FD&C red 40, flavor, glucose, glycerin, high fructose corn syrup, menthol, purified water, saccharin sodium, sodium benzoate

Questions or comments?

Call 1-503-639-6300 Monday-Friday 8AM-4PM PST

Principal Display Panel

Adult

Tussin DM 

COUGH SUPPRESSANT (DEXTROMETHORPHAN HBr)

EXPECTORANT (GUAIFENESIN)

COUGH & CHEST CONGESTION

NON-DROWSY

Relieves:

Cough

CHEST CONGESTION

MUCUS

For Ages 12 & Over

Alcohol Free

Gluten Free

FL OZ (mL)

COMPARE TO ROBITUSSIN® PEAK COLD COUGH + CHEST CONGESTION DM active ingredients*

*This product is not manufactured or distributed by Pfizer Consumer Healthcare, distributors of Robitussin® Peak Cold Cough and Chest Congestion DM.

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND BOTTLE OR UNDER CAP IS BROKEN OR MISSING.

Proudly Distributed by Western Family Foods, Inc

P.O. Box 4057, Portland, OR 97208 USA

www.westernfamily.com

Package Label

Dextromethorphan HBr 20 mg Guaifenesin 200 mg

Western Family Tussin DM

TUSSIN DM  ADULT
dextromethorphan hbr, guaifenesin liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 55312-385
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE20 mg  in 10 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg  in 10 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GLYCERIN (UNII: PDC6A3C0OX)  
HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)  
MENTHOL (UNII: L7T10EIP3A)  
WATER (UNII: 059QF0KO0R)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
DEXTROSE (UNII: IY9XDZ35W2)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 55312-385-081 in 1 BOX08/31/201512/31/2019
1237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34108/31/201512/31/2019
Labeler - Western Family Foods, Inc. (192166072)

Revised: 12/2018
Document Id: 3677093c-c4b5-4f7f-8bd6-ca24e3464558
Set id: 4ba63581-bfa3-4879-8268-3ae9c85818ca
Version: 2
Effective Time: 20181228
 
Western Family Foods, Inc.