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Topcare Anti-Diarrheal

Pronunciation

Generic Name: loperamide
Dosage Form: tablet

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Topco Anti-Diarrheal Tablets Drug Facts

Active ingredient (in each caplet)

Loperamide HCl 2 mg

Purpose

Anti-diarrheal

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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