STOMACH RELIEF- bismuth subsalicylate tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (SALICYLIC ACID - UNII:O414PZ4LPZ, BISMUTH CATION - UNII:ZS9CD1I8YE)

Available from:

SUPERVALU INC.

INN (International Name):

BISMUTH SUBSALICYLATE

Composition:

BISMUTH SUBSALICYLATE 262 mg

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

Upset stomach reliever/antidiarrheal relieves: - travelers’ diarrhea - diarrhea - upset stomach due to overindulgence in food and drink, including: belching indigestion gas fullness heartburn nausea - belching - indigestion - gas - fullness - heartburn - nausea

Authorization status:

OTC monograph final

Summary of Product characteristics

STOMACH RELIEF- BISMUTH SUBSALICYLATE TABLET
SUPERVALU INC.
_Disclaimer: Most OTC drugs are not reviewed and approved by FDA,
however they may be marketed if they_
_comply with applicable regulations and policies. FDA has not
evaluated whether this product complies._
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EQUALINE 44-346
_ACTIVE INGREDIENT (IN EACH CAPLET)_
Bismuth subsalicylate 262 mg
_PURPOSE_
Upset stomach reliever/antidiarrheal
_USES_
relieves:
travelers’ diarrhea
diarrhea
upset stomach due to overindulgence in food and drink, including:
belching
indigestion
gas
fullness
heartburn
nausea
_WARNINGS_
REYE'S SYNDROME: Children and teenagers who have or are recovering
from chicken pox or flu-like
symptoms should not use this product. When using this product, if
changes in behavior with nausea and
vomiting occur, consult a doctor because these symptoms could be an
early sign of Reye's syndrome, a
rare but serious illness.
ALLERGY ALERT: Contains salicylate. Do not take if you are:
allergic to salicylates (including aspirin)
taking other salicylate products
DO NOT USE
if you have
an ulcer
a bleeding problem
bloody or black stool
ASK A DOCTOR BEFORE USE IF YOU HAVE
fever
mucus in the stool
ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
taking any drug for
anticoagulation (thinning the blood)
gout
diabetes
arthritis
WHEN USING THIS PRODUCT
a temporary, but harmless, darkening of the stool and/or tongue may
occur.
STOP USE AND ASK A DOCTOR IF
symptoms get worse
ringing in the ears or loss of hearing occurs
diarrhea lasts more than 2 days
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_
swallow with water; do not chew
drink plenty of clear fluids to help prevent dehydration caused by
diarrhea
adults and children 12 years and over: 2 caplets every ½ to 1 hour as
needed. Do not exceed 8 doses
(16 caplets) in 24 hours.
use until diarrhea stops, but not more than 2 days
children und