Label: ANTI-DIARRHEAL- loperamide hydrochloride capsule, liquid filled
- NDC Code(s): 30142-520-24, 30142-520-72
- Packager: The Kroger Co.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Drug Label Information
Updated November 28, 2022
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- Official Label (Printer Friendly)
- Active ingredient (in each capsule)
- Purpose
- Use
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Warnings
Allergy alert: Do not use if you have ever had a rash or other allergic reaction to loperamide HCl.
Heart alert: Taking more than directed can cause serious heart problems or death.
When using this product
tiredness, drowsiness, or dizziness may occur. Be careful when driving or operating machinery.
- Directions
- Other information
- Inactive ingredients
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Principal Display Panel
COMPARE TO the active ingredient of IMODIUM® A-D *See side panel
Anti-Diarrheal
Loperamide HCI
Soft Gelatin Capsules 2 mg
CONTROLS THE SYMPTOMS OF DIARRHEA
Suitable for Adults and Children 12 Years and Over
SOFTGELS**
**each Liquid-Filled Capsule Contains 2 mg Loperamide HCI
*Imodium® A-D is a registered trademark of McNeil Consumer & Specialty Pharmaceuticals, Fort Washington, PA 19034, McNeil Consumer & Specialty Pharmaceuticals is not affiliated with The Kroger Co. or this product
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.
DISTRIBUTED BY THE KROGER CO., CINCINNATI, OHIO 45202
- Product Label
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INGREDIENTS AND APPEARANCE
ANTI-DIARRHEAL
loperamide hydrochloride capsule, liquid filledProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:30142-520 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 MONOCAPRYLATE (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 P13 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:30142-520-24 24 in 1 CARTON 12/31/2016 05/30/2025 1 1 in 1 BLISTER PACK; Type 0: Not a Combination Product 2 NDC:30142-520-72 72 in 1 CARTON 12/31/2016 05/30/2025 2 1 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 12/31/2016 05/30/2025 Labeler - The Kroger Co. (006999528)