Shoprite 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

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 20-25C (68-77F)
  • do not use if blister unit is broken or torn

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-SHOPRITE

Ingredients and appearance - Product information

Shoprite anti diarrheal tablet, film coated- Loperamide hcl

Product information

Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC: 41190-224
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)
Hypromelloses ( UNII: 3NXW29V3WO)
Magnesium stearate ( UNII: 70097M6I30)
Microcrystalline cellulose ( UNII: OP1R32D61U)
Polyethylene glycol ( UNII: 3WJQ0SDW1A)

Product Characteristics

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

Marketing Information

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

Labeler - Wakefern Food Corporation( 069722418)

Principal display panel

Compare to: Active Ingredient in Imodium® A-D

Loperamide Hydrochloride Tablets, 2 mg

ANTI-DIARRHEAL

Controls the Symptoms of Diarrhea

actual size

24 caplets*

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