ANTI DIARRHEAL- loperamide hydrochloride tablet, film coated 
Kroger Company

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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 the active ingredient of IMODIUM® A-D

See top panel

Loperamide Hydrochloride Tablets, 2 mg

Anti-Diarrheal

CONTROLS THE SYMPTOMS OF DIARRHEA

72 CAPLETS*

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

actual size

Anti-Diarrheal Image 1
Anti-Diarrheal Image 2
ANTI DIARRHEAL 
loperamide hydrochloride tablet, film coated
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:30142-998
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)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
Product Characteristics
Color GREEN Score 2 pieces
Shape CAPSULE Size 10mm
Flavor Imprint Code L2
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:30142-998-53 12 in 1 CARTON
1 1 in 1 BLISTER PACK
2 NDC:30142-998-62 24 in 1 CARTON
2 1 in 1 BLISTER PACK
3 NDC:30142-998-67 1 in 1 CARTON
3 48 in 1 BOTTLE
4 NDC:30142-998-23 1 in 1 CARTON
4 72 in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075232 02/21/2003
Labeler - Kroger Company (006999528)

Revised: 3/2014
Document Id: 5dac576f-4c02-48d7-9680-43b8fb37f139
Set id: 6bb37e85-b24c-4c0b-abdc-f89596396c11
Version: 2
Effective Time: 20140307
 
Kroger Company