NDC Code(s) : 62011-0139-1
Packager : McKesson

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Health Mart Simethicone Simethicone EMULSION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62011-0139
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DIMETHICONE(UNII: 92RU3N3Y1O)
(DIMETHICONE - UNII:92RU3N3Y1O) 		DIMETHICONE20 mg in 0.3 mL
Inactive Ingredients
Ingredient Name Strength
BENZOIC ACID(UNII: 8SKN0B0MIM)
CARBOXYMETHYLCELLULOSE(UNII: 05JZI7B19X)
D&C RED NO. 22(UNII: 1678RKX8RT)
D&C RED NO. 28(UNII: 767IP0Y5NH)
GLYCERYL MONOSTEARATE(UNII: 230OU9XXE4)
MAGNESIUM ALUMINUM SILICATE(UNII: 6M3P64V0NC)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
WATER(UNII: 059QF0KO0R)
SORBITOL(UNII: 506T60A25R)
XANTHAN GUM(UNII: TTV12P4NEE)
HYDROCHLORIC ACID(UNII: QTT17582CB)
SORBIC ACID(UNII: X045WJ989B)
SORBITAN MONOSTEARATE(UNII: NVZ4I0H58X)
Product Characteristics
Color pink Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:62011-0139-11 in 1 CARTON
130 mL in 1 BOTTLE, DROPPER
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part332 04/01/2012

PRINCIPAL DISPLAY PANEL

Health Mart Pharmacy

compare to Infant's Mylicon active ingredient

infants' gas relief drops

simethicone 20 mg

soothing relief for pressure, bloating and gas symptoms

1 fl oz (30 mL)infants gas relief drug factsinfants gas relief drug facts