Label: ANTI-DIARRHEAL- loperamide hydrochloride capsule, liquid filled
- NDC Code(s): 55315-520-24
- Packager: Freds Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Updated August 23, 2017
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- 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 problem 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 gets 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 Certer 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-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
Loperamide HCl, 2mg
Controls the symptoms of diarrhea
Suitable For Adults And Children 12 Years And Over
**EACH LIQUID-FILLED CAPSULE CANTAINS 2 MG LOPERAMIDE HCl
Compare To The Active Ingredients 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 & Specialty Pharmaceuticals, distributor of Imodium® A-D.
DISTRIBUTED BY: fred's, Inc.
4300 NEW GETWELL RD,,
MEMPHIS, TN 38118Close
- Product Label
FRED'S PHARMACY Anti-Diarrheal
- INGREDIENTS AND APPEARANCE
loperamide hydrochloride capsule, liquid filled
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55315-520 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:55315-520-24 2 in 1 CARTON 07/08/2010 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 07/08/2010 Labeler - Freds Inc (005866116)