Label: ANTI-DIARRHEAL LOPERAMIDE HCL- loperamide hydrochloride capsule, liquid filled
- NDC Code(s): 49348-752-04
- Packager: McKesson (Sunmark)
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Updated March 6, 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 thandirected 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 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-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, FDandC 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 IMODIUM® A-D ACTIVE INGREDIENT*
loperamide HCI, 2 mg
Soft Gelatin Capsules
Controls the symptoms of diarrhea
Suitable for adults and children 12 years and over
**each Liquid-capsule contains 2 mg Loperamide HCl
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.
Another Quality Product Distributed by McKesson
One Post Street, San Francisco, CA 94104
Please visit us at www.sunmarkbrand.com
- Product Label
- INGREDIENTS AND APPEARANCE
ANTI-DIARRHEAL LOPERAMIDE HCL
loperamide hydrochloride capsule, liquid filled
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49348-752 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 19mm Flavor Imprint Code P13 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49348-752-04 2 in 1 BOX 08/01/2006 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 08/01/2006 Labeler - McKesson (Sunmark) (177667227)