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Topcare Anti-Diarrheal Prescribing Information

Package insert / product label
Generic name: loperamide
Dosage form: tablet
Drug class: Antidiarrheals

Medically reviewed by Drugs.com. Last updated on Feb 28, 2024.

Active ingredient (in each caplet)

Loperamide HCl 2 mg

Purpose

Anti-diarrheal

Indications and Usage for Topcare Anti-Diarrheal

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).

Topcare Anti-Diarrheal Dosage and Administration

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

Storage and Handling

store at 20°-25°C (68°-77°F)
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?

1-888-423-0139

Principal Display Panel

COMPARE TO IMODIUM® A-D ACTIVE INGREDIENT

Anti-Diarrheal Tablets

LOPERAMIDE HYDROCHLORIDE TABLETS, 2 mg

Anti-Diarrheal

‚óŹ Controls the Symptoms of Diarrhea

12 CAPLETS†

†CAPSULE-SHAPED TABLETS

actual size

22488-anti-diarrheal
TOPCARE ANTI DIARRHEAL
loperamide hydrochloride tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-224
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LOPERAMIDE HYDROCHLORIDE (UNII: 77TI35393C) (LOPERAMIDE - UNII:6X9OC3H4II) LOPERAMIDE HYDROCHLORIDE2 mg
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
CARNAUBA WAX (UNII: R12CBM0EIZ)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
Product Characteristics
ColorGREENScore2 pieces
ShapeOVALSize10mm
FlavorImprint CodeL2
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:36800-224-916 in 1 CARTON08/07/2003
11 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:36800-224-5312 in 1 CARTON02/26/2003
21 in 1 BLISTER PACK; Type 0: Not a Combination Product
3NDC:36800-224-6224 in 1 CARTON04/22/2003
31 in 1 BLISTER PACK; Type 0: Not a Combination Product
4NDC:36800-224-801 in 1 CARTON11/12/200703/31/2020
496 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07523202/26/2003
Labeler - Topco Associates LLC (006935977)

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