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Sunmark Anti-Diarrheal Tablet

Package insert / prescribing information
Generic name: loperamide hydrochloride
Dosage form: tablet
Drug class: Antidiarrheals

Medically reviewed by Drugs.com. Last updated on Jul 22, 2022.

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°-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?

1-800-719-9260

Principal Display Panel

COMPARE TO IMODIUM® A-D ACTIVE INGREDIENT

See New Warnings

Loperamide Hydrochloride Tablets, 2 mg

anti-diarrheal

Controls the symptoms of diarrhea

ANTI-DIARRHEAL

Actual Size

12 CAPLETS*

(*Capsule-shaped tablets)

GLUTEN FREE

SUNMARK ANTI DIARRHEAL
loperamide hydrochloride tablet, film coated
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:49348-529
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LOPERAMIDE HYDROCHLORIDE (LOPERAMIDE) LOPERAMIDE HYDROCHLORIDE 2 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE
CARNAUBA WAX
HYPROMELLOSES
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOL
D&C YELLOW NO. 10
FD&C BLUE NO. 1
Product Characteristics
Color GREEN Score 2 pieces
Shape OVAL Size 10mm
Flavor Imprint Code L2
Contains
Packaging
# Item Code Package Description
1 NDC:49348-529-34 1 BOTTLE in 1 CARTON
1 96 TABLET, FILM COATED in 1 BOTTLE
2 NDC:49348-529-02 12 BLISTER PACK in 1 CARTON
2 1 TABLET, FILM COATED in 1 BLISTER PACK
3 NDC:49348-529-04 24 BLISTER PACK in 1 CARTON
3 1 TABLET, FILM COATED in 1 BLISTER PACK
4 NDC:49348-529-08 1 BOTTLE in 1 CARTON
4 48 TABLET, FILM COATED in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075232 06/27/2003
Labeler - Strategic Sourcing Services LLC (116956644)
Strategic Sourcing Services LLC

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