Label: LOPERAMIDE HYDROCHLORIDE capsule, liquid filled
- NDC Code(s): 11822-9590-3, 11822-9590-5, 11822-9590-6
- Packager: RITE AID CORPORATION
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated June 9, 2022
If you are a consumer or patient please visit this version.
- 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 DOCTOR/PHARMACIST
- WHEN USING
- Stop use and ask a doctor
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
- Directions
- Other information
- INACTIVE INGREDIENT
-
Questions or comments?
Dial 1-877-244-9825 on weekdays from 9 AM to 5 PM EST.
Manufactured by:
Strides Pharma Science Limited
Bengaluru-562106, India.
Distributed by:
Rite Aid
30 Hunter Lane, Camp Hill,
PA 17011.
Revised: 06/2022
†All trademarks are property of their respective owners. This product is not affiliated with the makers/owners of Imodium® A-D
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.
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
LOPERAMIDE HYDROCHLORIDE
loperamide hydrochloride capsule, liquid filledProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11822-9590 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 FD&C BLUE NO. 1 (UNII: H3R47K3TBD) BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U) GELATIN (UNII: 2G86QN327L) GLYCERIN (UNII: PDC6A3C0OX) GLYCERYL CAPRYLATE/CAPRATE (UNII: G7515SW10N) POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F) SHELLAC (UNII: 46N107B71O) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SODIUM LAURYL SULFATE (UNII: 368GB5141J) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color BLUE Score no score Shape OVAL Size 10mm Flavor Imprint Code L2 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11822-9590-5 2 in 1 CARTON 06/30/2024 1 NDC:11822-9590-3 12 in 1 BLISTER PACK; Type 0: Not a Combination Product 2 NDC:11822-9590-6 12 in 1 CARTON 06/30/2024 2 NDC:11822-9590-3 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 ANDA ANDA213070 06/30/2024 Labeler - RITE AID CORPORATION (014578892) Registrant - Strides Pharma Global Pte. Ltd. (659220961) Establishment Name Address ID/FEI Business Operations Strides Pharma Science Limited 918513263 ANALYSIS(11822-9590) , MANUFACTURE(11822-9590) , PACK(11822-9590)