Topcare Tussin DM

Dosage form: liquid
Ingredients: DEXTROMETHORPHAN HYDROBROMIDE 10mg in 5mL, GUAIFENESIN 100mg in 5mL
Labeler: Topco Associates LLC
NDC Code: 36800-359

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.

Topco Associates LLC. Tussin DM Drug Facts

Active ingredient (in each 5 mL tsp)

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 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 for more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign 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 right away. (1-800-222-1222)

Directions
do not take more than 6 doses in any 24-hour period
use only with enclosed measuring cup. Do not use any other device.
this adult product is not intended for use in children under 12 years of age

age

dose

adults and children

12 years and over

2 teaspoons (tsp) every 4 hours

children under 12 years

do not use

Other information
each teaspoon contains: sodium 3 mg
store at 20°-25°C (68°-77°F)

Inactive ingredients

anhydrous citric acid, FD&C red no. 40, flavor, glycerin, high fructose corn syrup, menthol, propylene glycol, purified water, sodium benzoate, sodium citrate, sucralose

Questions or comments?

1-888-423-0139

Principal Display Panel

FOR ADULTS

For Ages 12 & Over

Tussin DM

Cough & Chest Congestion DM

COUGH SUPPRESSANT (Dextromethorphan HBr)

EXPECTORANT (Guaifenesin)

Non-Drowsy

Relieves:

Cough

Chest Congestion/Mucus

COMPARE TO ROBITUSSIN® COUGH + CHEST CONGESTION DM active ingredients

TOPCARE TUSSIN DM 
dextromethorphan hydrobromide, guaifenesin liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-359
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE10 mg  in 5 mL
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN100 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID 
FD&C RED NO. 40 
GLYCERIN 
HIGH FRUCTOSE CORN SYRUP 
PROPYLENE GLYCOL 
WATER 
SODIUM BENZOATE 
MENTHOL 
SODIUM CITRATE 
SUCRALOSE 
Product Characteristics
ColorRED (Orange-Red) Score    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:36800-359-261 BOTTLE in 1 CARTON
1118 mL in 1 BOTTLE
2NDC:36800-359-341 BOTTLE in 1 CARTON
2237 mL in 1 BOTTLE
3NDC:36800-359-401 BOTTLE in 1 CARTON
3355 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34108/14/1991
Labeler - Topco Associates LLC (006935977)

Revised: 11/2012
 
Topco Associates LLC

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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