Label: ANTI-DIARRHEAL- loperamide hydrochloride capsule, liquid filled
- NDC Code(s): 59779-520-24, 59779-520-36, 59779-520-48
- Packager: CVS Pharmacy
- 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 HCl.
Do not use
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 1-800-222-1222.
- 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 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, FD&C Blue #1, gelatin, glycerin, glyceryl caprylate, polyoxyl 40 hydrogenated castor oil and purified water.Close
- Questions or comments?
Call toll free 1-800-447-1140Close
- Principal Display Panel
Compare to the active ingredient in Imodium® A-D †
CONTROLS THE SYMPTOMS OF DIARRHEA
LOPERAMIDE HCl SOFT GELATIN CAPSULES 2 mg
Suitable for adults and children 12 years and over
*Each liquid-filled capsule contains 2 mg loperamide hydrochloride
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.
Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
Product of U.S.A.
†This product is not manufactured or distributed by McNeil Consumer & Specialty Pharmaceuticals, owner of the registered trademark of Imodium® A-D.
- Product Label
CVS Anti-Diarrheal Softgel
- INGREDIENTS AND APPEARANCE
loperamide hydrochloride capsule, liquid filled
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59779-520 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 10mm Flavor Imprint Code P13 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59779-520-24 2 in 1 CARTON 1 12 in 1 BLISTER PACK 2 NDC:59779-520-36 3 in 1 CARTON 2 12 in 1 BLISTER PACK 3 NDC:59779-520-48 4 in 1 CARTON 3 12 in 1 BLISTER PACK Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA021855 07/08/2010 Labeler - CVS Pharmacy (062312574) Registrant - P and L Development of New York Corporation (800014821)