PINK-BISMUTH- bismuth subsalicylate liquid

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Guardian Drug Company

INN (International Name):

BISMUTH SUBSALICYLATE

Composition:

BISMUTH SUBSALICYLATE 262 mg in 15 mL

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

Upset stomach reliever and anti-diarrheal relieves: - diarrhea - heartburn - indigestion - nausea - upset stomach associated with these symptoms

Authorization status:

OTC monograph final

Summary of Product characteristics

PINK-BISMUTH - BISMUTH SUBSALICYLATE LIQUID
GUARDIAN DRUG COMPANY
_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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PINK-BISMUTH REGULAR STRENGTH
ACTIVE INGREDIENT (IN EACH 15 ML TBSP)
Bismuth subsalicylate 262 mg
PURPOSE
Upset stomach reliever and anti-diarrheal
USES
relieves:
diarrhea
heartburn
indigestion
nausea
upset stomach associated with these symptoms
WARNINGS
REYE'S SYNDROME: Children and teenagers who have or are recovering
from children
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 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 immediately.
DIRECTIONS
shake well before use
for accurate dosing, use dose cup
adults and children 12 years and over: 1 dose (2 tbsp or 30 mL) every
1/2 to 1 hour
as needed
do not exceed 8 doses (16 tbsp or 240 mL) 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 prevent dehydration caused b