MEDIQUE DIOTAME- bismuth subsalicylate suspension

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (SALICYLIC ACID - UNII:O414PZ4LPZ, BISMUTH CATION - UNII:ZS9CD1I8YE)

Available from:

Unique First Aid Corporation

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 / antidiarrheal Uses Temporarily relieves - traveler's diarrhea - diarrhea - upset stomach due to overindulgence in food and drink, including: - heartburn - indigestion - nausea - gas - belching - fullness Do not use if you have - an ulcer - a bleeding problem - bloody or black stool 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

Authorization status:

OTC monograph final

Summary of Product characteristics

MEDIQUE DIOTAME- BISMUTH SUBSALICYLATE SUSPENSION
UNIQUE FIRST AID CORPORATION
_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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MEDIQUE DIOTAME INSTYDOSE
_ACTIVE INGREDIENT_
Bismuth Salicylate 262 mg/15 ml
_PURPOSE_
Upset Stomach reliever / antidiarrheal
_USES_
TEMPORARILY RELIEVES
traveler's 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 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
an ulcer
a bleeding problem
bloody or black stool
ASK A DOCTOR BEFORE USE IF YOU HAVE
fever
mucus in the stool
ASK A DOCTOR OR PHARMACIST IF YOU ARE TAKING ANY DRUG FOR
anticoagulation (thinning of the blood)
diabetes
gout
arthritis
WHEN USING THIS PRODUCT a temporary and harmless darkening of the
tongue and/or
stool may occur. Stool darkening should not be confused with melena.
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_
Shake well before use
Drink plenty of clear fluids to help prevent dehydrationcaused by
diarrhea
ADULTS AND CHILDREN: (12 YEARS AND OVER)- Take 1 dose (2 tablespoons
or 30 ml)
every 1/2 to 1 hour, as needed.
Do not exceed 8 doses (16 Tbs