COUGH AND CHEST CONGESTION DM MAX- dextromethorphan hydrobromide and guaifenesin liquid
Rite Aid Corporation

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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Rite Aid Corporation Tussin Cough & Chest Congestion DM Max Drug Facts

Active ingredient (in each 5 mL tsp)

Dextromethorphan HBr, USP 10 mg

Guaifenesin, USP 200 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 occurs with 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

shake well before using
do not take more than 6 doses in any 24-hour period
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 every 4 hours
children under 12 years	do not use

Other information

each teaspoon contains: sodium 4 mg
store at 20°-25°C (68°-77°F)

Inactive ingredients

anhydrous citric acid, carboxymethylcellulose sodium, D&C red no. 33, FD&C red no. 40, flavor, glycerin, high fructose corn syrup, menthol, microcrystalline cellulose, polyethylene glycol, povidone, propylene glycol, purified water, saccharin sodium, sodium benzoate, sorbitol solution, xanthan gum

Questions or comments?

1-800-719-9260

Package/Label Principal Display Panel

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Compare to the active ingredients of Robitussin® Cough & Chest Congestion DM Max

MAXIMUM STRENGTH

tussin cough & chest congestion DM MAX

cough suppressant

(dextromethorphan HBr)

expectorant (guaifenesin)

NON-DROWSY

ALCOHOL FREE

relieves:

coughs

chest congestion/mucus

for adults & children 12 years & older

Tussin Cough & Chest Congestion DM Max Carton Image 1

Tussin Cough & Chest Congestion DM Max Carton Image 2

COUGH AND CHEST CONGESTION DM MAX
dextromethorphan hbr, guaifenesin liquid

Product Information
Product Type	HUMAN OTC DRUG LABEL	Item Code (Source)	NDC:11822-0799
Route of Administration	ORAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN)	DEXTROMETHORPHAN HYDROBROMIDE	10 mg in 5 mL
GUAIFENESIN (GUAIFENESIN)	GUAIFENESIN	200 mg in 5 mL

Ingredient Name	Strength
Inactive Ingredients
ANHYDROUS CITRIC ACID
CARBOXYMETHYLCELLULOSE SODIUM
D&C RED NO. 33
FD&C RED NO. 40
GLYCERIN
HIGH FRUCTOSE CORN SYRUP
MENTHOL
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOLS
POVIDONE
PROPYLENE GLYCOL
WATER
SACCHARIN SODIUM DIHYDRATE
SODIUM BENZOATE
SORBITOL
XANTHAN GUM

Product Characteristics
Color	RED (Opaque)	Score
Shape		Size
Flavor	CHERRY (Menthol)	Imprint Code
Contains

#	Item Code	Package Description
Packaging
1	NDC:11822-0799-2	1 in 1 CARTON
1		237 mL in 1 BOTTLE
2	NDC:11822-0799-1	1 in 1 CARTON
2		118 mL in 1 BOTTLE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	10/07/2011

Labeler - Rite Aid Corporation (014578892)

Revised: 4/2012

Document Id: ad0fa3fa-a859-4d0b-b679-e805d8efa226

Set id: ad0fa3fa-a859-4d0b-b679-e805d8efa226

Version: 1

Effective Time: 20120413

Rite Aid Corporation