FIRST AID DIRECT PEPTUM TABS- bismuth subsalicylate tablet, chewable

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Cintas Corp

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

Antidiarrheal/Antacid relieves - travelers' diarrhea - diarrhea - upset stomach due to overindulgence in food and drink including: - heartburn - indigestion - nausea - gas - belching - fullness

Authorization status:

OTC monograph final

Summary of Product characteristics

FIRST AID DIRECT PEPTUM TABS- BISMUTH SUBSALICYLATE TABLET, CHEWABLE
CINTAS CORP
----------
ACTIVE INGREDIENT (IN EACH TABLET)
Bismuth subsalicylate 262 mg
(each tablet contains 102mg salicylate)
PURPOSE
Antidiarrheal/Antacid
USES
relieves
travelers' diarrhea
diarrhea
upset stomach due to overindulgence in food and drink including:
heartburn
indigestion
nausea
gas
belching
fullness
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 occurs, 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 salicylate (including asprin)
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 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 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
chew or dissolve in mouth
ADULTS AND CHILDREN 12 YEARS AND OVER: 2 tablets (1 dose) every ½
hour or 4
tablets (2 doses) every hour as needed for diarrhea
2 tablets (1 dose) every 1/2 hour as needed for overindulgence (upset
stomach,
heartburn, indigestion, nausea)
do not exceed 8 doses (16 tablets) in 24 hours
use until diarrhea stops but not more than 2 days
CHILDREN UNDER 12: ask a doctor
drink plenty of fluids to help prevent dehydration which may accompany
diarrhe