Your browser does not support JavaScript! LOPERAMIDE HCL (LOPERAMIDE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [CHAIN DRUG CONSORTIUM, LLC]
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LOPERAMIDE HCL (loperamide hydrochloride) capsule, liquid filled
[Chain Drug Consortium, LLC]


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

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 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.
  • side effects occur. You may want to report side effects to FDA at 1800-FDA-1088.

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

  • do not use if carton or blister unit is open or torn
  • store at 20-25°C (68-77°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 FDandC blue #1, Gelatin, Glycerin, Glyceryl Caprylate, Polyoxyl 40 hydrogenated castor oil and purified water.

Product Labeling

Premier Value
Compare to the active ingredient in Imodium(r) A-D

Anti-Diarrheal
Loperamide HCl
Soft gelatin capsules, 2mg

Controls the Symptoms of Diarrhea
suitable for adults and children 12 years and over

12 softgels

Distributed by: Chan Drug Consortium, LLC
3301 NW Boca Raton Blvd. Suite 101
Boca Raton, FL 33431

Manufactured by
Banner Pharmacaps, Inc.
4215 Premier Drive
High Point, NC 27265

**This product is not manufactured or distributed by McNeil Consumer and Specialty Pharmaceuticals, owner of ther egistered trademark of Imodium (r) A-D.

Loperamide HCl

LOPERAMIDE HCL 
loperamide hydrochloride capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUG LABELItem 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 CAPRYLATE 
POLYOXYL 40 HYDROGENATED CASTOR OIL 
WATER 
Product Characteristics
ColorblueScoreno score
ShapeCAPSULESize9mm
FlavorImprint Code p13
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68016-193-122 in 1 BOX
112 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)

Revised: 12/2012
 
Chain Drug Consortium, LLC

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