Leader anti diarrheal tablet, film coated

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 20-25C (68-77F)
  • 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

Questions or comments?

1-800-719-9260

Ingredients and appearance - Product information

Leader anti diarrheal tablet, film coated- Loperamide hcl

Product information

Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC: 70000-0225
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Loperamide hydrochloride ( UNII: 77TI35393C)( Loperamide - UNII: 6X9OC3H4II ) 2 mgin 1

Inactive Ingredients

Ingredient Name Code
Anhydrous lactose ( UNII: 3SY5LH9PMK)
Carnauba wax ( UNII: R12CBM0EIZ)
D&c yellow no. 10 ( UNII: 35SW5USQ3G)
Fd&c blue no. 1 ( UNII: H3R47K3TBD)
Hypromellose, unspecified ( UNII: 3NXW29V3WO)
Magnesium stearate ( UNII: 70097M6I30)
Microcrystalline cellulose ( UNII: OP1R32D61U)
Polyethylene glycol, unspecified ( UNII: 3WJQ0SDW1A)

Product Characteristics

Color GREEN Size 10 mm
Shape OVAL Score 2
Imprint Code L2

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
ANDA ANDA075232 USA

Labeler - Cardinal Health( 097537435)

Principal display panel

Anti-Diarrheal

Loperamide Hydrochloride Tablets, 2 mg Anti-Diarrheal

Controls the Symptoms of Diarrhea

COMPARE TO IMODIUM® A-D

active ingredient

12 CAPLETS*

*Capsule-Shaped Tablets

Actual Size

100% Money Back Guarantee

SEE NEW WARNINGS

DO NOT USE IF BLISTER UNIT IS BROKEN OR TORN