ANTI DIARRHEAL- loperamide hydrochloride tablet, film coated

anti diarrheal by

Drug Labeling and Warnings

anti diarrheal by is a Otc medication manufactured, distributed, or labeled by Publix Super Markets Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each caplet)

Loperamide HCl 2 mg

Purpose

Anti-diarrheal

Use

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

Heart alert: Taking more than directed can cause serious heart problems or death

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
• a history of abnormal heart rhythm

Ask a doctor or pharmacist before use if you are

taking a prescription drug. Loperamide may interact with certain prescription drugs.

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 2-5 years (34 to 47 lbs):

  ask a doctor

• children under 2 years (up to 33 lbs):

  do not use

Other information

• store at 68°-77°F (20°-25°C)
• see end panel for lot number and expiration date

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

Principal Display Panel

LOPERAMIDE HYDROCHLORIDE TABLETS, 2 mg

antidiarrheal

ACTUAL SIZE

Controls the symptoms of diarrhea

Anti-diarrheal

12 CAPLETS*

*CAPSULE-SHAPED TABLETS

Compare to Imodium® A-D active ingredient

SEE NEW WARNINGS

INGREDIENTS AND APPEARANCE

ANTI DIARRHEAL 
loperamide hydrochloride tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 56062-224
Route of Administration	ORAL

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)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
HYPROMELLOSES (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 56062-224-53	12 in 1 CARTON	03/19/2003
1		1 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 56062-224-62	24 in 1 CARTON	03/25/2003
2		1 in 1 BLISTER PACK; Type 0: Not a Combination Product
3	NDC: 56062-224-80	1 in 1 CARTON	01/13/2005
3		96 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA075232	03/19/2003

Labeler - Publix Super Markets Inc (006922009)