NDC Code(s) : 0179-0173-80
Packager : KAISER FOUNDATION HOSPITALS

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

dicyclomine hydrochloridedicyclomine hydrochloride SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0179-0173(NDC:0603-1161)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DICYCLOMINE HYDROCHLORIDE(UNII: CQ903KQA31)
(DICYCLOMINE - UNII:4KV4X8IF6V) 		DICYCLOMINE HYDROCHLORIDE10 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
D&C RED NO. 33(UNII: 9DBA0SBB0L)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
FD&C RED NO. 40(UNII: WZB9127XOA)
FD&C YELLOW NO. 6(UNII: H77VEI93A8)
GLYCERIN(UNII: PDC6A3C0OX)
METHYLPARABEN(UNII: A2I8C7HI9T)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
PROPYLPARABEN(UNII: Z8IX2SC1OH)
SORBITOL(UNII: 506T60A25R)
SUCROSE(UNII: C151H8M554)
WATER(UNII: 059QF0KO0R)
Product Characteristics
Color PINK Score
Shape Size
Flavor FRUIT PUNCH Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0179-0173-8010 mL in 1 CUP, UNIT-DOSE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040169 04/02/2015

PRINCIPAL DISPLAY PANEL

Dicyclomine HCl Oral Solution Unit Dose Box Label

PRINCIPAL DISPLAY PANEL

Dicyclomine HCl Oral Solution Unit Dose Lid Label