LOPERAMIDE HYDROCHLORIDE- loperamide hydrochloride tablet 
Medline Industries, Inc.

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Drug Facts

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 (1-800-222-1222).

DIRECTIONS

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 1-800-MEDLINE (633-5463)

PRINCIPAL DISPLAY PANEL

MEDLINE

NDC 53329-664-57

Compare to the active ingredient in Imodium®A-D

LOPERAMIDE HCl TABLETS USP, 2 mg

ANTI-DIARRHEAL

Controls The Symptoms of Diarrhea

2 mg

12 Caplets*

Each Caplet (*capsule-shaped tablet)

contains Loperamide HCl USP, 2 mg

Distributed by: Medline Industries, Inc.

5099015/1012

12's blister carton label
LOPERAMIDE HYDROCHLORIDE 
loperamide hydrochloride tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:53329-664
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LOPERAMIDE HYDROCHLORIDE (UNII: 77TI35393C) (LOPERAMIDE - UNII:6X9OC3H4II) LOPERAMIDE HYDROCHLORIDE 2 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
CROSPOVIDONE (UNII: 68401960MK)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
TRISTEARIN (UNII: P6OCJ2551R)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POWDERED CELLULOSE (UNII: SMD1X3XO9M)  
STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)  
Product Characteristics
Color green Score 2 pieces
Shape CAPSULE Size 9mm
Flavor Imprint Code 123
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:53329-664-57 12 in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA074091 02/01/1993
Labeler - Medline Industries, Inc. (025460908)
Registrant - Ranbaxy Pharmaceuticals Inc. (937890044)
Establishment
Name Address ID/FEI Business Operations
Ohm Laboratories Inc. 051565745 manufacture(53329-664)

Revised: 3/2013
Document Id: ec51684e-1aa4-47d4-a2a0-5f5306578ef6
Set id: 03d68bcf-6413-4fe3-8263-39cc315452d2
Version: 1
Effective Time: 20130322
 
Medline Industries, Inc.