IMODIUM A-D- loperamide hydrochloride solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Johnson & Johnson Consumer Inc.

INN (International Name):

Loperamide Hydrochloride

Composition:

Loperamide Hydrochloride 1 mg in 7.5 mL

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

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

Authorization status:

New Drug Application

Summary of Product characteristics

IMODIUM A-D- LOPERAMIDE HYDROCHLORIDE SOLUTION
JOHNSON & JOHNSON CONSUMER INC.
----------
IMODIUM
A-D
_DRUG FACTS_
ACTIVE INGREDIENT (IN EACH 7.5 ML)
Loperamide HCl 1 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.
shake well before using
use only enclosed dosing cup specifically designed for use with this
product. Do not
use any other dosing device.
mL = milliliter
adults and
children 12
years and
over
30 mL after the first loose
stool; 15 mL after each
subsequent loose stool; but
no more than 60 mL in 24
hours
children 9-11
years (60-95
lbs)
15 mL after first loose stool;
7.5 mL after each subsequent
loose stool; but no more than
45 mL in 24 hours
children 6-8
years (48-59
lbs)
15 mL after first loose stool;
7.5 mL after each subsequent
loose stool; but no more than
30 mL in 24 hours
children 2-5
years (34 to
47 lbs)
ask a doctor
children
under 2
year