LEADER ANTI DIARRHEAL - loperamide hydrochloride tablet, film coated
Cardinal Health

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Active ingredient (in each caplet)

Loperamide HCl 2 mg

Purpose

Anti-diarrheal

Uses

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 HCl

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

symptoms get worse
diarrhea lasts for more than 2 days
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; 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 20°-25°C (68°-77°F)
do not use if printed foil under cap is broken or missing {Bottle Configurations Only}
do not use if blister unit is broken or torn {Blister Configurations Only}
see end panel for lot number and expiration date {Bottle Configurations Only}

Inactive ingredients

anhydrous lactose, carnauba wax, D&C yellow no. 10 aluminum lake, FD&C blue no. 1 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch

Questions or comments?

1-800-719-9260

Principal Display Panel

Easy Open Package {Non-CRC Configuration Only}

Compare to Imodium® A-D active ingredient

Loperamide Hydrochloride Tablets, 2 mg

Anti-Diarrheal

Controls the Symptoms of Diarrhea

*Each caplet (capsule-shaped tablet) contains 2 mg loperamide hydrochloride

This package for households without young children {Non-CRC Configuration Only}

Actual Size

Anti-Diarrheal Carton

LEADER ANTI DIARRHEAL
loperamide hcl tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:37205-370
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
ANHYDROUS LACTOSE
CARNAUBA WAX
D&C YELLOW NO. 10
FD&C BLUE NO. 1
HYPROMELLOSES
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOL

Product Characteristics
Color	GREEN	Score	2 pieces
Shape	CAPSULE	Size	9mm
Flavor		Imprint Code	L2
Contains

Packaging
#	Item Code	Package Description	Multilevel Packaging
1	NDC:37205-370-89	3 BLISTER PACK ( BLISTER PACK) in 1 CARTON	contains a BLISTER PACK
1		6 TABLET, FILM COATED ( TABLET) in 1 BLISTER PACK	This package is contained within the CARTON (37205-370-89)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA075232	04/02/2003

Labeler - Cardinal Health (097537435)

Revised: 08/2009 Cardinal Health