Loperamide HCl Anti-Diarrheal

Dosage form: capsule, liquid filled
Ingredients: LOPERAMIDE HYDROCHLORIDE 2mg
Labeler: P and L Development of New York Corporation (ReadyInCase)
NDC Code: 59726-520

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

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
  • 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-25°C (68º-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,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

Loperamide HCl

soft gelatin capsules 2 mg

anti-diarrheal

Controls the symptoms of diarrhea

Suitable for adults and children 12 years and over

Softgels**

(**each liquid-filled capsule contains 2 mg loperamide HCl)

†This product is not manufactured or distributed by McNeil Consumer & Specialty Pharmaceuticals, owner of the registered trademark of Imodium® A-D.

Distributed by:

PL Developments

200 Hicks Street, Westbury, NY  11590

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

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

Package Label

ReadyInCase Loperamide HCl 2 mg Softgel

LOPERAMIDE HCL ANTI-DIARRHEAL 
loperamide hydrochloride capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59726-520(NDC:10888-7098)
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 CAPRYLATE 
POLYOXYL 40 HYDROGENATED CASTOR OIL 
WATER 
Product Characteristics
ColorBLUEScoreno score
ShapeCAPSULESize19mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:59726-520-121 BLISTER PACK in 1 BOX
112 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
2NDC:59726-520-061 BLISTER PACK in 1 BOX
26 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02185508/30/2011
Labeler - P and L Development of New York Corporation (ReadyInCase) (800014821)

Revised: 04/2014
 
P and L Development of New York Corporation (ReadyInCase)

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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