LOPERAMIDE HYDROCHLORIDE - loperamide hydrochloride tablet 
Premier Value

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ACTIVE INGREDIENT (IN EACH CAPLET)

Loperamide HCI USP, 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 HCI

Do not use

if you have bloody or black stool

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

  • diarrhea lasts for more than 2 days
  • symptoms get worse
  • 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

adults and children 12 years and over2 caplets after the first loose stool;
1 caplet after each subsequent loose stool; but no more than 4 caplets in 24 hours
children 9-11 years
(60-95 lbs)		1 caplet after the first loose stool;
½ caplet after each subsequent loose stool; but no more than 3 caplets in 24 hours
children 6-8 years
(48-59 lbs)		1 caplet after the first loose stool;
½ caplet after each subsequent loose stool; but no more than 2 caplets in 24 hours
children under 6 years
(up to 47 lbs)		ask a doctor

OTHER INFORMATION

INACTIVE INGREDIENTS

anhydrous lactose, croscarmellose sodium, crospovidone, D&C yellow no.10, FD&C blue no.1, hydrogenated vegetable oil, magnesium stearate, powdered cellulose, pregelatinized starch

QUESTIONS

call 1800-406-7984

Keep the carton. It contains important information.

DISTRIBUTED BY

CHAIN DRUG CONSORTIUM

3301 NW BOCA RATON BLVD

SUITE 101, BOCA RATON, FL 33431

PRINCIPAL DISPLAY PANEL

Premier Value®

NDC 68016-123-18

Loperamide HCl tablets USP, 2 mg

Anti-Diarrheal

Controls The Symptoms of Diarrhea

18 CAPLETS*

Each caplet (*capsule-shaped tablet) contains Loperamide HCl USP, 2 mg

COMPARE TO THE ACTIVE INGREDIENT OF IMODIUM® A-D†

This product is not manufactured or distributed by McNeil-PPC, Inc., distributor of Imodium® A-D.

Imodium® is a registered trademark of Johnson & Johnson.

This is the 18 count blister carton label for Loperamide HCl tablets USP, 2 mg.
This is the 96 count bottle carton label for Loperamide HCl tablets USP, 2 mg.

LOPERAMIDE HYDROCHLORIDE 
loperamide hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-123
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LOPERAMIDE HYDROCHLORIDE (LOPERAMIDE) LOPERAMIDE HYDROCHLORIDE2 mg
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS LACTOSE 
CROSCARMELLOSE SODIUM 
CROSPOVIDONE 
D&C YELLOW NO. 10 
FD&C BLUE NO. 1 
TRISTEARIN 
MAGNESIUM STEARATE 
POWDERED CELLULOSE 
STARCH, PREGELATINIZED CORN 
Product Characteristics
ColorgreenScore2 pieces
ShapeCAPSULESize9mm
FlavorImprint Code 123
Contains    
Packaging
#Item CodePackage DescriptionMultilevel Packaging
1NDC:68016-123-066 TABLET ( TABLET) in 1 BLISTER PACKNone
2NDC:68016-123-1818 TABLET ( TABLET) in 1 BLISTER PACKNone
3NDC:68016-123-2424 TABLET ( TABLET) in 1 BLISTER PACKNone
4NDC:68016-123-9796 TABLET ( TABLET) in 1 BOTTLENone

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07409102/01/1993

Labeler - Premier Value (101668460)
Registrant - Ranbaxy Pharmaceuticals Inc. (937890044)
Establishment
NameAddressID/FEIOperations
Ohm Laboratories Inc.051565745manufacture

Revised: 07/2012 Premier Value