TUSSIN DM COUGH SUPPRESSANT/EXPECTORANT- dextromethorphan hydrobromide, guaifenesin liquid

Tussin DM by

Drug Labeling and Warnings

Tussin DM by is a Otc medication manufactured, distributed, or labeled by Chain Drug Consortium, LLC, AptaPharma Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Drug Facts

Active 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 Directions 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, menthol, 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

NDC: 68016-018-04

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

Premier Value®
Tussin DM

Dextromethorphan HBr
Guaifenesin

COUGH SUPPRESSANT /
EXPECTORANT

Helps to Loosen
Chest Congestion

NON-DROWSY

Cough Formula
for ages 12 and over


4 FL OZ (118 mL)

INDEPENDENTLY TESTED SATISFACTION GUARANTEED PV
DO NOT USE IF PRINTED SEAL UNDER CAP IS TORN OR MISSING

If for any reason you are not satisfied with this product, please return it to the store where purchased for a full refundd.
*This product is not manufactured or distributed by Pfizer, owner of the registered trademark Robitussin® Peak Cold.   

DISTRIBUTED BY:
CHAIN DRUG CONSORTIUM
3301 NW BOCA RATON BLVD
SUITE 101, BOCA RATON, FL 33431

BX-003

INGREDIENTS AND APPEARANCE

TUSSIN DM  COUGH SUPPRESSANT/EXPECTORANT
dextromethorphan hydrobromide, guaifenesin liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68016-018
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: 68016-018-04	118 mL in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	09/01/2012

Labeler - Chain Drug Consortium, LLC (101668460)

Registrant - AptaPharma Inc. (790523323)

Establishment
Name	Address	ID/FEI	Business Operations
AptaPharma Inc.		790523323	manufacture(68016-018)