Label: ANTI-DIARRHEAL- loperamide hydrochloride capsule, liquid filled
- NDC Code(s): 80136-851-42
- Packager: Northeast Pharma
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated December 30, 2022
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- 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
Distributed by:
NORTHEAST PHARMA
South Burlington, VT 05403
www.heartlandpharmaco.com
1-800-383-0648L0000440
Rev # 11/19
†This product is not manufactured or distributed by Johnson & Johnson, owner of the registered trademark 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.
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Principal Display Panel
NDC 80136-851-42
Heartland Pharma Co.
ANTI-DIARRHEAL
Loperamide HCl Capsules, 2 mg
Controls the Symptoms
of DiarrheaSuitable for adults and
children 12 years and over
actual size
Compare to active ingredient in Imodium ® A-D†
24 Softgels*
*soft gelatin liquid filled capsules
each softgel contains 2 mg loperamide HCl
carton
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INGREDIENTS AND APPEARANCE
ANTI-DIARRHEAL
loperamide hydrochloride capsule, liquid filledProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:80136-851 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:80136-851-42 2 in 1 CARTON 05/21/2021 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 05/21/2021 Labeler - Northeast Pharma (081232935) Registrant - Bionpharma Inc. (079637826) Establishment Name Address ID/FEI Business Operations Patheon Softgels Inc. 002193829 manufacture(80136-851)