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
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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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 DEA Schedule 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)