Your browser does not support JavaScript! ANTI-DIARRHEAL (LOPERAMIDE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [FREDS INC]
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ANTI-DIARRHEAL (loperamide hydrochloride) capsule, liquid filled
[Freds Inc]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL New Drug Application
Drug Label Sections

Drug Facts

Active Ingredient (in each capsule)

Loperamide HCI 2 mg

Purpose

Anti- diarrheal

Use

controls symptoms of diarrhea, including Traveler's Diarrhea

Warnings

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

Do not use

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 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

  • do not use if carton or blister unit is open or torn
  • store at 20o-25o C (68o-77o 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.

Questions or comments?

call toll free 1-800-447-1140

Principal Display Panel

COMPARE TO THE ACTIVE INGREDIENT IN IMODIUM® A-D **

Anti-Diarrheal

Loperamide HCl, 2mg

Controls the symptoms of diarrhea

24 SOFTGELS*

*each liquid-capsule contains 2 mg Loperamide HCl

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.

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

Manufactured by:

Banner Pharmacaps Inc

4125 premier drive, high point, NC 27265

Product Label

Freds Inc

Loperamide HCl 2 mg softgels

ANTI-DIARRHEAL 
loperamide hydrochloride capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:55315-520
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 CAPRYLATE 
POLYOXYL 40 HYDROGENATED CASTOR OIL 
WATER 
Product Characteristics
ColorBLUEScoreno score
ShapeCAPSULESize10mm
FlavorImprint Code P13
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55315-520-242 in 1 CARTON
112 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02185507/08/2010
Labeler - Freds Inc (005866116)
Registrant - P and L Development of New York Corporation (800014821)

Revised: 1/2013
 
Freds Inc

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