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 (1-800-222-1222).

DIRECTIONS

•: drink plenty of clear fluids to help prevent dehydration caused by diarrhea
•: find right dose on chart. If possible, use weight to dose; otherwise, use age.

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

•: store between 20° – 25° C (68° – 77° F)
•: see side panel for lot number and expiration date
•: TAMPER EVIDENT: THIS PRODUCT PROTECTED WITH SEALED BLISTER UNITS. DO NOT USE IF ANY ARE TORN OR BROKEN.

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.

New Brunswick, NJ 08901

Relabeled by:

Proficient Rx LP

Thousand Oaks, CA 91320

PRINCIPAL DISPLAY PANEL

NDC 63187-462-12

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

Imodium®is a registered trademark of Johnson & Johnson.

LOPERAMIDE HYDROCHLORIDE
loperamide hydrochloride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:63187-462(NDC:51660-123)
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
LOPERAMIDE HYDROCHLORIDE (UNII: 77TI35393C) (LOPERAMIDE - UNII:6X9OC3H4II)	LOPERAMIDE HYDROCHLORIDE	2 mg

Ingredient Name	Strength
Inactive Ingredients
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
CROSPOVIDONE (120 .MU.M) (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, CORN (UNII: O8232NY3SJ)
GLYCERYL TRISTEARATE (UNII: P6OCJ2551R)
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)

Product Characteristics
Color	green	Score	2 pieces
Shape	CAPSULE	Size	9mm
Flavor		Imprint Code	123
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:63187-462-12	12 in 1 BLISTER PACK; Type 0: Not a Combination Product	03/27/2014

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA074091	02/01/1993

Labeler - Proficient Rx LP (079196022)

Name	Address	ID/FEI	Business Operations
Establishment
Proficient Rx LP		079196022	REPACK(63187-462) , RELABEL(63187-462)

Drug Facts