Label: LOPERAMIDE HCL- loperamide hydrochloride capsule, liquid filled
- NDC Code(s): 68016-193-12
- Packager: Chain Drug Consortium, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Updated December 5, 2012
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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 HClClose
- Do not use
- 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.
- side effects occur. You may want to report side effects to FDA at 1800-FDA-1088.
- 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 away.Close
- 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
- do not use if carton or blister unit is open or torn
- store at 20-25°C (68-77°F)
- avoid excessive heat above 40°C (104°F).
- see side panel for lot number and expiration date
- use the 1 mg soft gelatin capsule product for children 6 to under 12 years of age
- Inactive ingredients
Butylated hydroxyanisole, edible ink FDandC blue #1, Gelatin, Glycerin, Glyceryl Caprylate, Polyoxyl 40 hydrogenated castor oil and purified water.
- Product Labeling
Compare to the active ingredient in Imodium(r) A-D
Soft gelatin capsules, 2mg
Controls the Symptoms of Diarrhea
suitable for adults and children 12 years and over
Distributed by: Chan Drug Consortium, LLC
3301 NW Boca Raton Blvd. Suite 101
Boca Raton, FL 33431
Banner Pharmacaps, Inc.
4215 Premier Drive
High Point, NC 27265
**This product is not manufactured or distributed by McNeil Consumer and Specialty Pharmaceuticals, owner of ther egistered trademark of Imodium (r) A-D.
- INGREDIENTS AND APPEARANCE
loperamide hydrochloride capsule, liquid filled
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68016-193 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 CAPRYLATE (UNII: TM2TZD4G4A) POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F) WATER (UNII: 059QF0KO0R) Product Characteristics Color blue Score no score Shape CAPSULE Size 9mm Flavor Imprint Code p13 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68016-193-12 2 in 1 BOX 1 12 in 1 BLISTER PACK Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA021855 12/04/2012 Labeler - Chain Drug Consortium, LLC (101668460)