Topcare Anti-Diarrheal

Pronunciation

Generic Name: loperamide
Dosage Form: tablet

Topco Anti-Diarrheal Tablets Drug Facts

Active ingredient (in each caplet)

Loperamide HCl 2 mg

Purpose

Anti-diarrheal

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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.

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 between 20-25°C (68-77°F)
  • do not use if printed foil under cap is broken or missing (Bottle Only)
  • do not use if carton or blister unit is broken or torn (Blister Only)
  • see end panel for lot number and expiration date

Inactive ingredients

anhydrous lactose, carnauba wax, D&C yellow no. 10, FD&C blue no. 1, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch

Questions or comments?

1-888-423-0139

Principal Display Panel

Easy to Swallow

Loperamide Hydrochloride Tablets, 2 mg

Anti-Diarrheal Tablets

Controls the Symptoms of Diarrhea, Including Travelers’ Diarrhea

Actual Size

Compare to Imodium® A-D active ingredient

Each Caplet (Capsule-Shaped Tablet) Contains 2 mg Loperamide Hydrochloride

Anti-Diarrheal Tablets Carton


TOPCARE ANTI DIARRHEAL 
loperamide hydrochloride tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:36800-224
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LOPERAMIDE HYDROCHLORIDE (LOPERAMIDE) LOPERAMIDE HYDROCHLORIDE 2 mg
Product Characteristics
Color GREEN Score 2 pieces
Shape CAPSULE Size 10mm
Flavor Imprint Code L2
Contains         
Packaging
# Item Code Package Description
1 NDC:36800-224-91 1 BLISTER PACK (BLISTER PACK) in 1 CARTON
1 6 TABLET (TABLET) in 1 BLISTER PACK
2 NDC:36800-224-53 2 BLISTER PACK (BLISTER PACK) in 1 CARTON
2 6 TABLET (TABLET) in 1 BLISTER PACK
3 NDC:36800-224-62 4 BLISTER PACK (BLISTER PACK) in 1 CARTON
3 6 TABLET (TABLET) in 1 BLISTER PACK
4 NDC:36800-224-80 1 BOTTLE (BOTTLE) in 1 CARTON
4 96 TABLET (TABLET) in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075232 02/26/2003
Labeler - Topco Associates LLC (006935977)
Revised: 08/2009
 
Topco Associates LLC



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