COUGH SUPPRESSANT AND EXPECTORANT DM- tussin dm liquid 
We Care Distributor 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

Dextromethorphan HBr, USP 10 mg
Guaifenesin, USP 100 mg

Purpose

Cough suppressant
Expectorant

Uses

temporarily relieves cough due to minor throat and bronchial irritation as may occur with cold. It helps helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive

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

Stop use and ask a doctor if

cough lasts more than 7 days, comes back, or accompanied by fever, rash, or persistant headache.

These could be signs of a serious condition.

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of the reach of children.

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

Directions

          AGE                                     DOSE

adults and children

12 years of age and over               10 mL    

children 6 years to

under 12 years of age                    5 mL

children 2 years to

under 6 years of age                      2.5 mL

children under

under 2 years of age                      ask a doctor

Other information

Inactive ingredients

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

** contains one or more of these ingredients

Principal Display Panel

Compare to the Active Ingredients in Robitussin DM

Dextromethorphan HBr, 10 mg - guaifenesin, 100 mg

cough suppressant, expectorant

Non-Drowsy

Alcohol Free

Relieves- coughs, chest congestion and mucus

2 FL Oz (60 mL)

image description

COUGH SUPPRESSANT AND EXPECTORANT DM 
tussin dm liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70005-044
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Dextromethorphan Hydrobromide (UNII: 9D2RTI9KYH) (Dextromethorphan - UNII:7355X3ROTS) Dextromethorphan Hydrobromide10 mg  in 5 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN100 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
DEXTROSE (UNII: IY9XDZ35W2)  
GLYCERIN (UNII: PDC6A3C0OX)  
HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)  
MENTHOL (UNII: L7T10EIP3A)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
Product Characteristics
Color    Score    
ShapeSize
FlavorCHERRY (Cherry) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70005-044-011 in 1 CARTON06/29/2016
160 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 finalpart34106/29/2016
Labeler - We Care Distributor Inc. (079832998)
Establishment
NameAddressID/FEIBusiness Operations
PURINE PHARMA LLC019950491manufacture(70005-044)

Revised: 8/2016
Document Id: dc3abb69-1bf1-4b3e-8160-05b0cf619290
Set id: 2f8ed05f-7e52-4714-895a-912008d1b74f
Version: 3
Effective Time: 20160802
 
We Care Distributor Inc.