Kroger Co. Anti-Diarrheal Drug Facts

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 blister unit is broken or torn {For use on Blister Cartons Only}
•: do not use if printed foil under cap is broken or missing {For use on Bottle Cartons Only}
•: see end panel for lot number and expiration date {For use on Bottle Cartons 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?

1-800-632-6900

Principal Display Panel

COMPARE TO active ingredient of IMODIUM® A-D

See side panel

Loperamide Hydrochloride Tablets, 2 mg

Anti-Diarrheal

Controls the Symptoms of Diarrhea

Actual Size

*Each caplet (capsule-shaped tablet) contains 2 mg Loperamide Hydrochloride

ANTI DIARRHEAL
loperamide hydrochloride tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG LABEL	Item Code (Source)	NDC:30142-998
Route of Administration	ORAL	DEA Schedule

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

Ingredient Name	Strength
Inactive Ingredients
ANHYDROUS LACTOSE
CARNAUBA WAX
HYPROMELLOSES
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOLS
D&C YELLOW NO. 10
FD&C BLUE NO. 1

Product Characteristics
Color	GREEN	Score	2 pieces
Shape	CAPSULE	Size	10mm
Flavor		Imprint Code	L2
Contains

#	Item Code	Package Description
Packaging
1	NDC:30142-998-53	2 in 1 CARTON
1		6 in 1 BLISTER PACK
2	NDC:30142-998-62	4 in 1 CARTON
2		6 in 1 BLISTER PACK
3	NDC:30142-998-67	1 in 1 CARTON
3		48 in 1 BOTTLE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA075232	02/21/2003

Labeler - Kroger Company (006999528)

Revised: 2/2013

Document Id: 6bb37e85-b24c-4c0b-abdc-f89596396c11

Set id: 6bb37e85-b24c-4c0b-abdc-f89596396c11

Version: 1

Effective Time: 20130212

Kroger Company