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 August 12, 2016
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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
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
SUNMARK Anti-Diarrheal Softgels
- 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 07/09/2010 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 07/09/2010 Labeler - McKesson (Sunmark) (177667227)