ANTI-DIARRHEAL- loperamide hydrochloride capsule, liquid filled 
CVS Pharmacy

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Drug Facts

Active ingredient (in each capsule)

Loperamide HCI 2 mg

Purpose

Anti-diarrheal

Use

controls symptoms of diarrhea, including Travelers' Diarrhea

Warnings

Allergy alert: Do not use if you have ever had a rash or other allergic reaction to loperamide HCl.

Do not use

  • if you have bloody or black stool
  • in children under 12 years of age (see Other information)

Ask a doctor before use if you have

  • fever
  • mucus in the stool
  • a history of liver disease

Ask a doctor or pharmacist before use if you are

taking antibiotics.

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.

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

Other information

Inactive ingredients

butylated hydroxyanisole, edible ink, FD&C Blue #1, gelatin, glycerin, glyceryl caprylate, polyoxyl 40 hydrogenated castor oil and purified water.

Questions or comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

Compare to the active ingredient in Imodium® A-D †

ANTI-DIARRHEAL

CONTROLS THE SYMPTOMS OF DIARRHEA

LOPERAMIDE HCl SOFT GELATIN CAPSULES 2 mg

Suitable for adults and children 12 years and over

SOFTGELS*

*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

www.cvs.com

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

Lopermainde HCl 2 mg

CVS Anti-Diarrheal Softgels

ANTI-DIARRHEAL 
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:59779-520-48 4 in 1 CARTON
1 12 in 1 BLISTER PACK; Type 0: Not a Combination Product
2 NDC:59779-520-24 2 in 1 CARTON
2 12 in 1 BLISTER PACK; Type 0: Not a Combination Product
3 NDC:59779-520-36 3 in 1 CARTON
3 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 07/08/2010
Labeler - CVS Pharmacy (062312574)
Registrant - P & L Development, LLC (800014821)

Revised: 8/2015
Document Id: bcd1980f-e12c-4a8c-8238-f0b970a81957
Set id: dcebde46-a36c-4b00-a07f-90eaf07871c4
Version: 4
Effective Time: 20150803
 
CVS Pharmacy