TUSSIN DM COUGH AND CHEST CONGESTION- dextromethorphan hydrobromide, guaifenesin liquid

Tussin DM by

Drug Labeling and Warnings

Tussin DM by is a Otc medication manufactured, distributed, or labeled by DeMoulas Market Basket, AptaPharma Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug FactsActive ingredients(in each 5 mL tsp)

Dextromethorphan HBr, USP 10 mg
Guaifenesin, USP 100 mg

Purpose

Cough Suppressant
Expectorant

Keep out of reach of children

Keep out of reach of children.

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

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

• in a child under 12 years of age
• 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.

Directions

• do not take more than 6 doses in any 24-hour period

Other information

• Keep carton for full Direction for use.

• store at 20‐25 ° C (68‐77 ° F)
• do not refrigerate
• dosage cup provided
• sodium 3 mg per teaspoonful
  

Inactive ingredients

anhydrous citric acid, dextrose, FD and C red no. 40, flavor, glycerin, high fructose corn syrup, purified water, saccharin sodium, sodium benzoate

Questions?

Call weekdays from 9:30 AM to 4:30 PM EST at

1-877-798-5944

Product Label

"MORE FOR YOUR DOLLAR"

MARKET BASKET®

*COMPARE TO THE ACTIVE INGREDIENTS IN ROBITUSSIN® PEAK COLD COUGH and CHEST CONGESTION DM

Tussin DM

Cough and Chest Congestion

Dextromethorphan HBr
Guaifenesin

COUGH SUPPRESSANT /
EXPECTORANT

Helps to Loosen Chest Congestion

NON-DROWSY

ADULT
Cough Formula

for ages 12 and over

8 FL OZ (237 mL)

DO NOT USE IF IMPRINTED SHRINK BAND IS MISSING OR BROKEN

*This product is not manufactured or distributed by Pfizer, owner of the registered trademark Robitussin® Peak Cold.  

Distributed by: DEMOULAS SUPERMARKETS INC.
875 EAST STREET - TEWKSBURY, MA 01876

BX-012 REV 01

INGREDIENTS AND APPEARANCE

TUSSIN DM  COUGH AND CHEST CONGESTION
dextromethorphan hydrobromide, guaifenesin liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53942-503
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	10 mg  in 5 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	100 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
DEXTROSE (UNII: IY9XDZ35W2)
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53942-503-26	237 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/01/2012

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	10/01/2012

Labeler - DeMoulas Market Basket (007869647)

Registrant - AptaPharma Inc. (790523323)

Establishment
Name	Address	ID/FEI	Business Operations
AptaPharma Inc.		790523323	manufacture(53942-503)