LOPERAMIDE HCL tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

L.N.K. International, Inc.

INN (International Name):

LOPERAMIDE HYDROCHLORIDE

Composition:

LOPERAMIDE HYDROCHLORIDE 2 mg

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

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

Authorization status:

Export only

Summary of Product characteristics

LOPERAMIDE HCL- LOPERAMIDE HCL TABLET
L.N.K. INTERNATIONAL, INC.
----------
KIRKWOOD 44-375
_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.
DO NOT USE
if you have bloody or black stool.
ASK A DOCTOR BEFORE USE IF YOU HAVE
a 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 (1-800-222-1222) 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_
TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS
TORN OR BROKEN
store between 20°-25°C (68°-77°F)
see end flap for expiration date and lot number
_INACTIVE INGREDIENTS_
corn starch, D&C yellow #10 aluminum lake, dicalcium phosphate
dihydrate, FD&C blue #1 brilliant
blue