NDC Code(s) : 69976-003-01, 69976-003-02
Packager : HR Pharma LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Anne Geddes Infant Anti-Gas DropsSimethicone LIQUID
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69976-003
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DIMETHICONE(UNII: 92RU3N3Y1O)
(DIMETHICONE - UNII:92RU3N3Y1O) 		DIMETHICONE21 mg in 100 mL
Inactive Ingredients
Ingredient Name Strength
CARBOMER 940(UNII: 4Q93RCW27E)
Ethylparaben(UNII: 14255EXE39)
METHYLPARABEN(UNII: A2I8C7HI9T)
dill(UNII: Y05PC4JZRH)
PROPYLPARABEN(UNII: Z8IX2SC1OH)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
Sucrose(UNII: C151H8M554)
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:69976-003-021 in 1 CARTON
1NDC:69976-003-01100 mL in 1 BOTTLE Type 1: Convenience Kit of Co-Package
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part332 09/22/2015

PRINCIPAL DISPLAY PANEL

Anne Geddes

Infant Anti-Gas Drops

3.4 fl oz (100 ml)

Carton

Carton

Carton