LOPERAMIDE HYDROCHLORIDE - loperamide hydrochloride tablet 
Physicians Total Care, Inc.

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Drug Facts

ACTIVE INGREDIENT (IN EACH CAPLET)

Loperamide HCl USP, 2 mg

PURPOSE

Anti-diarrheal

USE(S)

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 over
2 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:

Ohm Laboratories Inc.

1385 Livingston Avenue

North Brunswick, NJ 08902

PRINCIPAL DISPLAY PANEL

NDC 54868-6312-0

Loperamide HCl Tablets, USP 2 mg

Anti-Diarrheal

12 CAPLETS

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

Controls The Symptoms of Diarrhea

*Compare to the active ingredient of Imodium® A-D

This is the 12 count blister carton label for Loperamide hydrochloride tablets.
LOPERAMIDE HYDROCHLORIDE 
loperamide hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54868-6312(NDC:51660-123)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LOPERAMIDE HYDROCHLORIDE (UNII: 77TI35393C) (LOPERAMIDE - UNII:6X9OC3H4II) LOPERAMIDE HYDROCHLORIDE2 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
CROSPOVIDONE (UNII: 68401960MK)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POWDERED CELLULOSE (UNII: SMD1X3XO9M)  
STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)  
TRISTEARIN (UNII: P6OCJ2551R)  
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
Product Characteristics
ColorgreenScore2 pieces
ShapeCAPSULESize9mm
FlavorImprint Code 123
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54868-6312-012 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07409109/24/2011
Labeler - Physicians Total Care, Inc. (194123980)
Establishment
NameAddressID/FEIBusiness Operations
Physicians Total Care, Inc.194123980relabel

Revised: 4/2012
Document Id: d30f22f1-8c60-4072-bcdb-ac5d41edb796
Set id: 812d636c-82d5-4eef-b154-cdf065943122
Version: 1
Effective Time: 20120426
 
Physicians Total Care, Inc.