PEP TUM- bismuth subsalicylate tablet, chewable

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

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Hent Produktets egenskaber (SPC)
22-12-2017

Aktiv bestanddel:

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

Tilgængelig fra:

First Aid Direct

Indgivelsesvej:

ORAL

Recept type:

OTC DRUG

Terapeutiske indikationer:

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

Autorisation status:

OTC monograph final

Produktets egenskaber

                                PEP TUM- BISMUTH SUBSALICYLATE TABLET, CHEWABLE
FIRST AID DIRECT
_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._
----------
DRUG FACTS
ACTIVE INGREDIENT (IN EACH TABLET)
Bismuth subsalicylate 262 mg (each tablet contains 102 mg salicylate)
PURPOS E
Antidiarrheal/Antacid
US ES
controls diarrhea
relieves heartburn, indigestion, nausea and upset stomach without
constipating
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 OR PHARMACIST BEFORE USE IF YOU
are taking any drug for anticoagulation (thinning the blood)
diabetes
gout
arthritis
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
WHEN USING THIS PRODUCT
a temporary, but harmless, darkening of the stool and/or tongue may
occur.
IF PREGNANT OR BREAST-FEEDING,
ask a health professional before use.
KEEP OUT OF REACH OF CHILDREN.
In case of accidental overdose, contact a doctor or Poison Control
Center immediately.
DIRECTIONS
drink plenty of clear fluids to help prevent dehydration caused by
diarrhea
ADULTS AND CHILDREN 12 YEARS AND OVER: 525 mg (2 tablets) every ½ to
1 hour or 1050 mg (4
tablets) every hour as needed
do not exceed 4200 mg ( 16 tablets) in 24 hours
use until diarrhea stops but not more than 2 days
CHILDREN UNDER 12 YEARS: ask a doctor
INACTIVE INGREDIENTS
aspartame, calcium carbonate, , D&C red #27, dextrates, flavor
                                
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