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Loperamide HCl by Chain Drug Consortium, LLC

Medically reviewed on March 1, 2017

Dosage form: capsule, liquid filled
Ingredients: LOPERAMIDE HYDROCHLORIDE 2mg
Labeler: Chain Drug Consortium, LLC
NDC Code: 68016-193

Premier Value Loperamide HCl Capsules

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 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 20º-25°C (68º-77°F). 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, 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

Loperamide HCI

Soft Gelatin Capsules, 2 mg

Controls the Symptoms of Diarrhea

Suitable for adults and children 12 years and over

Softgels**

**each liquid-filled capsule

contains 2 mg loperamide HCI

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

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: Pharmacy Value Alliance, LLC

407 East Lancaster Avenue,

Wayne, PA 19087

Product Labeling

PREMIER VALUE Anti-Diarrheal

LOPERAMIDE HCL 
loperamide hydrochloride capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-193
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
ShapeCAPSULESize9mm
FlavorImprint Codep13
Contains    
Packaging
#Item CodePackage Description
1NDC:68016-193-122 BLISTER PACK in 1 BOX
112 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02185512/04/2012
Labeler - Chain Drug Consortium, LLC (101668460)

 
Chain Drug Consortium, LLC

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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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