NDC Code(s) : 55758-305-08
Packager : Pharmadel LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

EstomaxBismuth Subsalicylate LIQUID
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55758-305
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BISMUTH SUBSALICYLATE(UNII: 62TEY51RR1)
(SALICYLIC ACID - UNII:O414PZ4LPZ) 		BISMUTH SUBSALICYLATE262 mg in 15 mL
Inactive Ingredients
Ingredient Name Strength
BENZOIC ACID(UNII: 8SKN0B0MIM)
D&C RED NO. 22(UNII: 1678RKX8RT)
D&C RED NO. 28(UNII: 767IP0Y5NH)
KAOLIN(UNII: 24H4NWX5CO)
MAGNESIUM(UNII: I38ZP9992A)
ALUMINUM SILICATE(UNII: T1FAD4SS2M)
SALICYLIC ACID(UNII: O414PZ4LPZ)
SACCHARIN SODIUM ANHYDROUS(UNII: I4807BK602)
SODIUM SALICYLATE(UNII: WIQ1H85SYP)
SORBIC ACID(UNII: X045WJ989B)
SUCRALOSE(UNII: 96K6UQ3ZD4)
WATER(UNII: 059QF0KO0R)
XANTHAN GUM(UNII: TTV12P4NEE)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:55758-305-081 in 1 CARTON
1240 mL in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part335 02/21/2012

PRINCIPAL DISPLAY PANEL

Estomax Label