NDC Code(s) : 11822-1003-2, 11822-1003-1, 11822-1003-3
Packager : Rite Aid Corporation

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

anti diarrheal anti gasloperamide hydrochloride, simethicone TABLET
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:11822-1003
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LOPERAMIDE HYDROCHLORIDE(UNII: 77TI35393C)
(LOPERAMIDE - UNII:6X9OC3H4II) 		LOPERAMIDE HYDROCHLORIDE2 mg
DIMETHICONE(UNII: 92RU3N3Y1O)
(DIMETHICONE - UNII:92RU3N3Y1O) 		DIMETHICONE125 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
ACESULFAME POTASSIUM(UNII: 23OV73Q5G9)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
ANHYDROUS DIBASIC CALCIUM PHOSPHATE(UNII: L11K75P92J)
MALTODEXTRIN(UNII: 7CVR7L4A2D)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
STEARIC ACID(UNII: 4ELV7Z65AP)
Product Characteristics
Color WHITE Score 2 pieces
Shape OVAL Size 17 mm
Flavor Imprint Code L0R1;2;125
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:11822-1003-212 in 1 CARTON 01/03/2019
11 in 1 BLISTER PACK Type 0: Not a Combination Product
2NDC:11822-1003-11 in 1 CARTON 01/03/2019
242 in 1 BOTTLE Type 0: Not a Combination Product
3NDC:11822-1003-324 in 1 CARTON 24/02/2020
31 in 1 BLISTER PACK Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA209837 01/03/2019

LABELER - Rite Aid Corporation(014578892)

PRINCIPAL DISPLAY PANEL

Compare to the active ingredients of Imodium® Multi-Symptom Relief

ANTI-DIARRHEAL/ANTI-GAS

LOPERAMIDE HYDROCHLORIDE & SIMETHICONE TABLETS, 2 mg/125 mg

ANTI-DIARRHEAL/ANTI-GAS

Multi-symptom relief caplet

Relieves symptoms of diarrhea plus:

cramps & pressure

bloating/gas

ACTUAL SIZE

24 CAPLETS*

*CAPSULE-SHAPED TABLETS

0R183-anti-diarrheal-anti-gas.jpg