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
Updated November 6, 2018
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- Active ingredient (in each capsule)
Loperamide HCI 2 mgClose
controls symptoms of diarrhea, including Travelers' DiarrheaClose
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.
Stop use and ask a doctor if
- symptoms get worse
- diarrhea lasts for more than 2 days
- you get abdominal swelling or bulging. These may be signs of a serious condition.
Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center right away.
- drink plenty of clear fluids to help prevent dehydration caused by diarrhea
- not for use in children under 12 years of age
- adults and children 12 years of age and over: 2 softgels after the first loose stool; 1 softgel after each subsequent loose stool; but no more than 4 softgels in 24 hours
- Other information
- store at 20º-25ºC (68º-77ºF), Protect from light.
- avoid excessive heat above 40°C (104°F)
- do not use if carton or blister unit is open or torn
- see side panel for lot number and expiration date
- Inactive ingredients
butylated hydroxyanisole, edible ink, FD&C Blue #1, gelatin, glycerin, glyceryl caprylate, polyoxyl 40 hydrogenated castor oil and purified waterClose
- Questions or comments?
Call 1-877-753-3935 Monday-Friday 9AM-5PM ESTClose
- Principal Display Panel
Capsules, 2 mg
Controls The Symptoms Of Diarrhea
Suitable for adults and children 12 years and over
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
- Product Label
- INGREDIENTS AND APPEARANCE
loperamide hcl capsule, liquid filled
Product 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 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 Labeler - Cardinal Health (Leader) 70000 (097537435)