PEPTO RELIEF- bismuth subsalicylate tablet, chewable

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (BISMUTH CATION - UNII:ZS9CD1I8YE)

Available from:

Richmond Pharmaceuticals, Inc

INN (International Name):

BISMUTH SUBSALICYLATE

Composition:

BISMUTH SUBSALICYLATE 262 mg

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

Anti-diarrheal/Upset stomach reliever - Controls diarrhea - Relieves upset stomach due to overindulgence in food or drink

Authorization status:

OTC monograph final

Summary of Product characteristics

PEPTO RELIEF- BISMUTH SUBSALICYLATE TABLET, CHEWABLE
RICHMOND PHARMACEUTICALS, 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._
----------
PEPTO RELIEF BISMUTH SUBSALICYLATE 262 MG
DRUG FACTS
.
ACTIVE INGREDIENT
(IN EACH TABLET)
Bismuth subsalicylate 262 mg
PURPOS E
Anti-diarrheal/Upset stomach reliever
US ES
Controls diarrhea
Relieves upset stomach due to overindulgence in food or drink
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: 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
If you have an ulcer or 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 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 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 right away.
DIRECTIONS
drink plenty of clear fluids to help prevent dehydration caused by
diarrhea
repeat dosage every 1/2 to 1 hour as needed
do not take more than 8 doses in 24 hours
use until diarrhea stops but not more than 2 days
ADULTS AND CHILDREN 12 YEARS AND OVER: 2 tablets
CHILDREN UNDER 12 YEARS: ask a doctor
OTHER INFORMATION
EACH TABLET CONTAINS: calci