Label: ANTI-DIARRHEAL- loperamide hydrochloride capsule, liquid filled
- NDC Code(s): 0363-1176-08, 0363-1176-12
- Packager: WALGREENS
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Drug Label Information
Updated December 29, 2022
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient (in each capsule)
- Purpose
- Use
- Warnings
- Do not use
- Ask a doctor before use if you have
- Ask a doctor or pharmacist before use if you are
- When using this product
- Stop use and ask a doctor if
- If pregnant or breast-feeding,
- Keep out of reach of children.
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
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SPL UNCLASSIFIED SECTION
THIS PRODUCT IS PACKAGED IN A CHILD-RESISTANT AND TAMPER EVIDENT PACKAGE. USE ONLY IF BLISTERS ARE INTACT.
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.
†Walgreens Pharmacist Survey
†Our pharmacists recommend the Walgreens brand. We invite you to compare to national brands.
††This product is not manufactured or distributed by Johnson & Johnson Consumer Inc., owner of the registered trademark Imodium ® A-D.DISTRIBUTED BY: WALGREEN CO.
200 WILMOT RD., DEERFIELD, IL 60015L0000507
Lot#
Expiration Date
Rev 07/21
- Principal Display Panel
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INGREDIENTS AND APPEARANCE
ANTI-DIARRHEAL
loperamide hydrochloride capsule, liquid filledProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-1176 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LOPERAMIDE HYDROCHLORIDE (UNII: 77TI35393C) (LOPERAMIDE - UNII:6X9OC3H4II) LOPERAMIDE HYDROCHLORIDE 2 mg Inactive Ingredients Ingredient Name Strength BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) GELATIN (UNII: 2G86QN327L) GLYCERIN (UNII: PDC6A3C0OX) GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A) POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F) WATER (UNII: 059QF0KO0R) Product Characteristics Color blue Score no score Shape CAPSULE Size 10mm Flavor Imprint Code LP2 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0363-1176-12 2 in 1 CARTON 06/15/2018 1 12 in 1 BLISTER PACK; Type 0: Not a Combination Product 2 NDC:0363-1176-08 1 in 1 CARTON 03/19/2020 2 12 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 NDA NDA021855 06/15/2018 Labeler - WALGREENS (008965063) Registrant - Bionpharma Inc. (079637826) Establishment Name Address ID/FEI Business Operations Patheon Softgels Inc. 002193829 manufacture(0363-1176)