NDC Code(s) : 37205-686-26
Packager : Cardinal Health

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

leader tussindextromethorphan hbr, guaifenesin SUSPENSION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:37205-686
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DEXTROMETHORPHAN HYDROBROMIDE(UNII: 9D2RTI9KYH)
(DEXTROMETHORPHAN - UNII:7355X3ROTS) 		DEXTROMETHORPHAN HYDROBROMIDE20 mg in 10 mL
GUAIFENESIN(UNII: 495W7451VQ)
(GUAIFENESIN - UNII:495W7451VQ) 		GUAIFENESIN400 mg in 10 mL
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS CITRIC ACID(UNII: XF417D3PSL)
D&C RED NO. 33(UNII: 9DBA0SBB0L)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
FD&C RED NO. 40(UNII: WZB9127XOA)
GLYCERIN(UNII: PDC6A3C0OX)
HIGH FRUCTOSE CORN SYRUP(UNII: XY6UN3QB6S)
MENTHOL(UNII: L7T10EIP3A)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
CARBOXYMETHYLCELLULOSE SODIUM(UNII: K679OBS311)
POLYETHYLENE GLYCOLS(UNII: 3WJQ0SDW1A)
POVIDONES(UNII: FZ989GH94E)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
WATER(UNII: 059QF0KO0R)
SACCHARIN SODIUM(UNII: SB8ZUX40TY)
SODIUM BENZOATE(UNII: OJ245FE5EU)
SORBITOL(UNII: 506T60A25R)
XANTHAN GUM(UNII: TTV12P4NEE)
Product Characteristics
Color PURPLE (opaque, viscous) Score
Shape Size
Flavor BERRY Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:37205-686-261 in 1 CARTON
1118 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 08/13/2012

PRINCIPAL DISPLAY PANEL

Compare to Robitussin® Maximum Strength Cough + Chest Congestion DM active ingredients

For Ages 12 & Over

Adult

Tussin DM MAX

Cough Suppressant (Dextromethorphan HBr)

Expectorant (Guaifenesin)

Cough + Chest Congestion DM

Relieves:

Cough

Mucus

Non-Drowsy

Mixed Berry Flavor

Alcohol Free

4 FL OZ (118 mL)

Leader Adult Tussin DM MAX Image