Label: ANTI-DIARRHEAL- loperamide hcl capsule, liquid filled
- NDC Code(s): 70000-0230-1
- Packager: Cardinal Health (Leader) 70000
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Drug Label Information
Updated October 6, 2021
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- Active ingredient (in each capsule)
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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
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- Inactive ingredients
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Principal Display Panel
Loperamide Hydrochloride
Capsules, 2 mg
Anti-Diarrheal
Controls The Symptoms Of Diarrhea
Suitable for adults and children 12 years and over
SOFTGELS*
*(Liquid-filled Capsules)
COMPARE TO IMODIUM® A-D active ingredient**
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 Johnson & Johnson Consumer, Inc., distributor of Imodium® A-D.
DISTRIBUTED BY CARDINAL HEALTH
DUNLIN, OHIO 43017
www.myleader.com 1-800-200-6313
- Product Label
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INGREDIENTS AND APPEARANCE
ANTI-DIARRHEAL
loperamide hcl capsule, liquid filledProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70000-0230 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:70000-0230-1 2 in 1 CARTON 01/31/2017 12/31/2023 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 01/31/2017 12/31/2023 Labeler - Cardinal Health (Leader) 70000 (063997360)