TUSSIN DM MAX ADULT COUGH PLUS CHEST CONGESTION- dextromethorphan hbr, guaifenesin liquid

TUSSIN DM MAX ADULT COUGH PLUS CHEST CONGESTION by

Drug Labeling and Warnings

TUSSIN DM MAX ADULT COUGH PLUS CHEST CONGESTION by is a Otc medication manufactured, distributed, or labeled by Marc Glassman, Inc., Aurohealth LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients (in each 10 mL)

Dextromethorphan HBr, USP 20 mg
Guaifenesin, USP 400 mg

Purposes

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 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.

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 (12 tsp) in any 24-hour period
• measure only with dosing cup provided 
• keep dosing cup with product
• mL = milliliter
• this adult product is not intended for use in children under 12 years of age

• Age: Dose
• adults and children 12 years and over: 10 mL; every 4 hours
• children under 12 years: do not use

Other information

• each 10 mL contains: sodium 8 mg
• store at 20-25°C (68-77°F). Do not refrigerate
• alcohol-free
• see bottom panel for lot number and expiration date 

Inactive ingredients

anhydrous citric acid, carboxymethylcellulose sodium, D&C red #33, FD&C red #40, flavors, glycerin, high fructose corn syrup, menthol, microcrystalline cellulose, polyethylene glycol, povidone, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose, xanthan gum.

QUESTIONS

Distributed by:
Marc Glassman, Inc.
West 130th Street
Cleveland, OH 44130

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 8 FL OZ (237 mL Bottle)

NDC: 68998-386-20

Compare to the active ingredients in
Adult Robitussin® Peak Cold
Maximum strength Cough + Chest
Congestion DM Max*

Marcs

adult
Tussin DM Max
COUGH + CHEST
CONGESTION

Dextromethorphan HBr
(Cough Suppressant)
Guaifenesin
(Expectorant)

For Relief of:
Cough
Mucus

For Ages 12 & Over
Cherry Flavor
Non-Drowsy                               

8 FL OZ (237 mL)

INGREDIENTS AND APPEARANCE

TUSSIN DM MAX ADULT COUGH PLUS CHEST CONGESTION 
dextromethorphan hbr, guaifenesin liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68998-386
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	20 mg  in 10 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	400 mg  in 10 mL

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
FD&C RED NO. 40 (UNII: WZB9127XOA)
CHERRY (UNII: BUC5I9595W)
VANILLA (UNII: Q74T35078H)
GLYCERIN (UNII: PDC6A3C0OX)
HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)
LEVOMENTHOL (UNII: BZ1R15MTK7)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
POVIDONE K30 (UNII: U725QWY32X)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SORBITOL (UNII: 506T60A25R)
SUCRALOSE (UNII: 96K6UQ3ZD4)
XANTHAN GUM (UNII: TTV12P4NEE)

Product Characteristics
Color	RED (a red colored liquid)	Score
Shape		Size
Flavor	CHERRY, VANILLA	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68998-386-20	1 in 1 CARTON	08/11/2015
1		237 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	08/11/2015

Labeler - Marc Glassman, Inc. (094487477)

Registrant - Aurohealth LLC (078728447)

Establishment
Name	Address	ID/FEI	Business Operations
Aurohealth LLC		078728447	MANUFACTURE(68998-386)