Label: ANTI-DIARRHEAL- loperamide hydrochloride capsule, liquid filled
- NDC Code(s): 50804-520-12
- Packager: Good Sense (Geiss, Destin & Dunn, Inc.)
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Drug Label Information
Updated April 3, 2024
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- Official Label (Printer Friendly)
- Drug Facts
- 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 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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Principal Display Panel
Liquid-Filled Softgels
Anti-Diarrheal
Soft Gelatin Capsules, 2 mg
Loperamide HCl
Controls the symptoms of diarrhea
Suitable for adults and children 12 years and over
SOFTGELS*
*each liquid- filled capsule contains 2 mg Loperamide HCl
**Compare to active ingredient in 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
**This product is not manufactured or distributed by McNeil Consumer and Specialty Pharmaceuticals, distributor of Imodium® A-D.
Distributed by:
Geiss, Destin & Dunn, Inc.
Peachtree City, GA 30269
- 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:50804-520 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:50804-520-12 1 in 1 BOX 07/15/2010 01/15/2025 1 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 07/15/2010 01/15/2025 Labeler - Good Sense (Geiss, Destin & Dunn, Inc.) (076059836)