FOSTER AND THRIVE 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)

Available from:

Strategic Sourcing Services LLC

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

Upset stomach reliever and anti-diarrheal relieves: - indigestion - nausea - heartburn - diarrhea - upset stomach associated with these symptoms - bloody or black stool - an ulcer - a bleeding problem - fever - mucus in the stool taking any drug for  - anticoagulation (thinning of the blood) - diabetes - gout - arthritis - symptoms get worse - ringing in the ears or loss of hearing occurs - diarrhea lasts more than 2 days

Authorization status:

OTC monograph final

Summary of Product characteristics

FOSTER AND THRIVE STOMACH RELIEF - BISMUTH SUBSALICYLATE TABLET
STRATEGIC SOURCING SERVICES LLC
_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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FOSTER AND THRIVE STOMACH RELIEF CAPLETS 172
ACTIVE INGREDIENT(IN EACH CAPLET)
Bismuth subsalicylate 262 mg
PURPOSE
Upset stomach reliever and anti-diarrheal
USE(S)
relieves:
indigestion
nausea
heartburn
diarrhea
upset stomach associated with these symptoms
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
bloody or black stool
an ulcer
a bleeding problem
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 of the blood)
diabetes
gout
arthritis
WHEN USING THIS PRODUCT
a temporary, but harmless darkening of the stool and/or tongue may
occur.
STOP USE AND ASK 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 immediately(1-
800-222-1222).
DIRECTIONS
swallow caplet(s) with water, do not chew
adults and children 12 years and over: 2 caplets every 1/2 to 1 hour
as needed
do not take more than 8 doses (16 caplets) in 24 hours
use until diarrhea stops but not more than 2 days
children under 12 years: ask a doctor
drink plenty of clear fluids to help