Active ingredient (in each caplet)

Loperamide HCl 2 mg

Purpose

Antidiarrheal

Use

controls symptoms of diarrhea, including Travelers' Diarrhea

Warnings

Allergy alert: Do not use if you have ever had a rash or other allergic reactions to loperamide HCl.

Do not use

if you have bloody or black stool.

Ask a doctor before use if you have

high 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

symptoms get worse
diarrhea lasts for more than 2 days
you get abdominal swelling or buldging. 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 (1-800-222-1222) right away.

Directions

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

adults and children 12 years and older	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 first loose stool; 1/2 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; 1/2 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 at controlled room temperature 20º-25ºC (68º-77ºF)
see end flap for expiration date and lot number

Inactive ingredients

corn starch, D&C yellow # 10 aluminum lake, dicalcium phosphate dihydrate, FD&C blue #1 brilliant blue lake, magnesium stearate, microcrystalline cellulose, silica gel

Questions or comments?

Call 1-800-426-9391 8:30 AM-4:00 PM ET, Monday-Friday

Principal Display Panel

12 caplets

SOUNDBODY™

ANTI DIARRHEAL
LOPERAMIDE HYDROCHLORIDE 2 mg

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

12 caplets

*This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Imodium® A-D.
50844 REV1212E37502

Manufactured by: LNK International, Inc.
Hauppauge, NY 11788

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

SoundBody 44-375

ANTI DIARRHEAL
loperamide hcl tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:50594-375
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LOPERAMIDE HYDROCHLORIDE (LOPERAMIDE)	LOPERAMIDE HYDROCHLORIDE	2 mg

Inactive Ingredients
Ingredient Name	Strength
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE

Product Characteristics
Color	BLUE	Score	no score
Shape	CAPSULE	Size	10mm
Flavor		Imprint Code	44;375
Contains

Packaging
#	Item Code	Package Description
1	NDC:50594-375-02	1 in 1 CARTON
1		12 in 1 BLISTER PACK

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA076497	05/03/2005

Labeler - Big Lots Stores, Inc. (017885351)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		038154464	PACK(50594-375)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		832867894	MANUFACTURE(50594-375)

Revised: 04/2013

Document Id: 50d262fd-9d12-4346-8a9d-88dd1d5d2300

Set id: a46b6ead-0991-45e4-b26e-dac89a388d81

Version: 2

Effective Time: 20130403

Big Lots Stores, Inc.