TUSSIN COUGH EXPECTORANT COUGH SUPRESSANT DM- dextromethorphan hydrobromide, guaifenesin liquid

TUSSIN COUGH by

Drug Labeling and Warnings

TUSSIN COUGH by is a Otc medication manufactured, distributed, or labeled by Salado Sales, Inc., 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 You 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

Age                                       Dose

adults & children                     2 teaspoonfuls
12 years and over                  every 4 hours

children under 12 years           do not use

Other information

• store at 20-25° C (66-77° F)
• do not refrigerate
• dosage cup provided
• sodium 3 mg per teaspoon

Inactive ingredients

Anhydrous citric acid, dextrose, FD & C red # 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

Tussin Cough DM product label

* COMPARE TO ROBITUSSIN® PEAK COLD ACTIVE INGREDIENTS

CVP® CONSUMER VALUE PRODUCTS

TUSSIN COUGH EXPECTORANT COUGH SUPPRESSANT DM

NON-DROWSY COUGH FORMULA

• ADULT
• FOR AGES 12 AND OVER
• CONTROLS COUGH
• HELPS LOOSEN CHEST CONGESTION

4 FL OZ (118 Ml)

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

Box-001 Rev 01

DO NOT USE IF PRINTED SEAL UNDER CAP IS TORN OR MISSING

Distributed by: Salado Sales, Inc.  P.O. Box 6115 Temple, TX 76503  www.saladosales.com

LOT.

EXP.

INGREDIENTS AND APPEARANCE

TUSSIN COUGH  EXPECTORANT COUGH SUPRESSANT DM
dextromethorphan hydrobromide, guaifenesin liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57243-503
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
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
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: 57243-503-24	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/01/2012

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

Labeler - Salado Sales, Inc. (009830555)

Registrant - AptaPharma Inc. (790523323)

Establishment
Name	Address	ID/FEI	Business Operations
AptaPharma Inc.		790523323	manufacture(57243-503)