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Anti-Diarrheal Loperamide HCl by TOP CARE (Topco Associates LLC)

Medically reviewed on Mar 6, 2017

Dosage form: capsule, liquid filled
Ingredients: LOPERAMIDE HYDROCHLORIDE 2mg
Labeler: TOP CARE (Topco Associates LLC)
NDC Code: 36800-520

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.

Heart alert: Taking more than directed can cause serious heart problems or death.

Do not use
  • if you have bloody or black stool
  • in children under 12 years of age

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
  • 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-77ºF). 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, FD&C blue #1, gelatin, glycerin, glyceryl caprylate, polyoxyl 40 hydrogenated castor oil and purified water

Questions or comments?

Call toll free 1-888-423-0139

Principal Display Panel

CONTROLS THE SYMPTOMS OF DIARRHEA

Anti-Diarrheal Loperamide HCl

SOFT GELATIN CAPSULES, 2 mg

  • Suitable for adults and children 12 years and over

COMPARE TO IMODIUM® A-D active ingredient**

SOFTGELS*

*each liquid-filled capsule contains 2 mg Loperamide HCl

*This product is not manufactured or distributed by McNeil Consumer & Specialty Pharmaceuticals, distributor of Imodium® A-D.

DISTRIBUTED BY TOPCO ASSOCIATES LLC

ELK GROVE VILLAGE, IL 60007

topcare@topco.comwww.topcarebrand.com

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

THIS PRODUCT IS PACKAGING IN A CHILD RESISTANT AND TAMPER EVIDENT PACKAGE. USE ONLY IF BLISTERS ARE INTACT.

Product Label

TOPCARE Anti-Diarrheal

ANTI-DIARRHEAL LOPERAMIDE HCL 
loperamide hydrochloride capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-520
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LOPERAMIDE HYDROCHLORIDE (LOPERAMIDE) LOPERAMIDE HYDROCHLORIDE2 mg
Inactive Ingredients
Ingredient NameStrength
BUTYLATED HYDROXYANISOLE 
FD&C BLUE NO. 1 
GELATIN 
GLYCERIN 
GLYCERYL MONOCAPRYLATE 
POLYOXYL 40 HYDROGENATED CASTOR OIL 
WATER 
Product Characteristics
ColorBLUEScoreno score
ShapeCAPSULESize10mm
FlavorImprint CodeP13
Contains    
Packaging
#Item CodePackage Description
1NDC:36800-520-242 BLISTER PACK in 1 CARTON
112 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
2NDC:36800-520-121 BLISTER PACK in 1 CARTON
212 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02185507/16/2010
Labeler - TOP CARE (Topco Associates LLC) (006935977)

 
TOP CARE (Topco Associates LLC)

← See all Anti-Diarrheal Loperamide HCl brands

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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