IMODIUM MULTI-SYMPTOM RELIEF- loperamide hydrochloride and dimethicone tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

LOPERAMIDE HYDROCHLORIDE (UNII: 77TI35393C) (LOPERAMIDE - UNII:6X9OC3H4II), DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)

Available from:

Johnson & Johnson Consumer Inc.

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

relieves symptoms of diarrhea plus bloating, pressure and cramps, commonly referred to as gas

Authorization status:

New Drug Application

Summary of Product characteristics

IMODIUM MULTI-SYMPTOM RELIEF- LOPERAMIDE HYDROCHLORIDE AND
DIMETHICONE TABLET
JOHNSON & JOHNSON CONSUMER INC.
----------
IMODIUM
MULTI-SYMPTOM RELIEF
_DRUG FACTS_
_ACTIVE INGREDIENTS (IN EACH_
_CAPLET)_
_PURPOSES_
Loperamide HCl 2 mg
Anti-
diarrheal
Simethicone 125 mg
Anti-gas
USES
relieves symptoms of diarrhea plus bloating, pressure and cramps,
commonly referred
to as gas
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
if you have difficulty swallowing
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.
you have difficulty swallowing the caplet
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
take only on an empty stomach (1 hour before or 2 hours after a meal)
take with a full (8 oz.) glass of water
find right dose on chart below. 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;
½ caplet after each subsequent
loose stool; but no more than 3
caplets in 24 hours
children 6-8
years
(48-5