Label: ANTI-DIARRHEAL- loperamide hydrochloride capsule, liquid filled
- NDC Code(s): 41520-520-12
- Packager: Care One (American Sales Company)
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Updated April 21, 2017
If you are a consumer or patient please visit this version.
- Drug Facts
- Active Ingredient (in each capsule)
Loperamide HCI 2 mgClose
controls symptoms of diarrhea, including Traveler's 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 deathClose
- Do not use
- if you have bloody or black stool
- in children under 12 years of age
- Ask a doctor before use if you have
- mucus in the stool
- a history of liver disease
- Ask a doctor or pharmacist before use if you are
- When using this product
tiredness, drowsiness, or dizziness may occur. Be careful when driving or operating machinery.Close
- Stop use and ask 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.
- If pregnant or breast-feeding,
ask a health professional before use.Close
- Keep out of reach of children
In case of overdose, get medical help or contact a Poison Control Center right awayClose
- 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-25o C (68o-77o F). 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 water.Close
- Questions or comments?
call 1-877-753-3935- Monday-Friday 9AM-5PM ESTClose
- Principal Display Panel
Compare to the active ingredient in Imodium® A-D†
2 mg Loperamide HCI
CONTROL SYMPTOMS OF DIARRHEA
SUITABLE FOR ADULTS AND CHILDREN
12 YEARS AND OVER
**each liquid-filled capsule contains 2 mg Loperamide HCl.
†This product is not manufactured or distributed by McNeil Consumer & Specialty Pharmaceuticals, distributor of 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
DISTRIBUTED BY FOODHOLD U.S.A., LLC
LANDOVER, MD 20785 • 1-877-846-9949Close
- Product Label
- INGREDIENTS AND APPEARANCE
loperamide hydrochloride capsule, liquid filled
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:41520-520 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:41520-520-12 1 in 1 CARTON 08/05/2010 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 08/05/2010 Labeler - Care One (American Sales Company) (809183973) Registrant - P & L Development, LLC (800014821)