ANTI DIARRHEAL- loperamide hcl tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

LOPERAMIDE HYDROCHLORIDE (UNII: 77TI35393C) (LOPERAMIDE - UNII:6X9OC3H4II)

Available from:

THIRTY MADISON INC

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

Anti-diarrheal controls symptoms of diarrhea, including Travelers’ Diarrhea

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ANTI DIARRHEAL- LOPERAMIDE HCL TABLET, FILM COATED
THIRTY MADISON INC
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THIRTY MADISON INC. ANTI-DIARRHEAL DRUG FACTS
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
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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
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fever
mucus in the stool
a history of liver disease
a history of abnormal heart rhythm
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
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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
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INACTIVE INGREDIENTS
anhydrous lactose, carnauba wax, D&C yellow no. 10 aluminum lake, FD&C
blue no. 1
aluminum lake, hypromellose, magnesium stearate, microcry