Bismuth subsalicylate

Bismuth subsalicylate
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Rabin Bista, M.B.B.S. [2]

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NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Bismuth subsalicylate is a OTC antacid that is FDA approved for the treatment of diarrhea, heartburn, indigestion, nausea, upset stomach. Common adverse reactions include darkening of the stool and/or tongue.

• relieves:

• diarrhea
• heartburn
• indigestion
• nausea
• upset stomach associated with these symptoms

• chew or dissolve in mouth
• adults and children 12 years and over: 2 tablets every 1/2 to 1 hour as needed
• do not take more than 8 doses (16 tablets) in 24 hours
• children under 12 years: ask a doctor
• drink plenty of fluids to help prevent dehydration which may accompany diarrhea.
• Other information: each tablet contains:

• sodium less than 1 mg
• salicylate 102 mg
• calcium 140 mg
• very low sodium
• avoid excessive heat (over 104˚F or 40˚C)

• TAMPER EVIDENT: Do not use if individual compartments are torn or missing.

There is limited information regarding Off-Label Guideline-Supported Use of Bismuth subsalicylate in adult patients.

There is limited information regarding Off-Label Non–Guideline-Supported Use of Bismuth subsalicylate in adult patients.

• children 12 years and over: 2 tablets every 1/2 to 1 hour as needed

There is limited information regarding Off-Label Guideline-Supported Use of Bismuth subsalicylate in pediatric patients.

There is limited information regarding Off-Label Non–Guideline-Supported Use of Bismuth subsalicylate in pediatric patients.

There is limited information regarding Bismuth subsalicylate Contraindications in the drug label.

• 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.

• 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 stools
• 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 aretaking 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.

darkening of the stool and/or tongue

There is limited information regarding Postmarketing Experience of Bismuth subsalicylate in the drug label.

There is limited information regarding Bismuth subsalicylate Drug Interactions in the drug label.

Pregnancy Category (FDA):

• Pregnancy Category

Pregnancy Category (AUS):

• Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Bismuth subsalicylate in women who are pregnant.

There is no FDA guidance on use of Bismuth subsalicylate during labor and delivery.

There is no FDA guidance on the use of Bismuth subsalicylate with respect to nursing mothers.

There is no FDA guidance on the use of Bismuth subsalicylate with respect to pediatric patients.

There is no FDA guidance on the use of Bismuth subsalicylate with respect to geriatric patients.

There is no FDA guidance on the use of Bismuth subsalicylate with respect to specific gender populations.

There is no FDA guidance on the use of Bismuth subsalicylate with respect to specific racial populations.

There is no FDA guidance on the use of Bismuth subsalicylate in patients with renal impairment.

There is no FDA guidance on the use of Bismuth subsalicylate in patients with hepatic impairment.

There is no FDA guidance on the use of Bismuth subsalicylate in women of reproductive potentials and males.

There is no FDA guidance one the use of Bismuth subsalicylate in patients who are immunocompromised.

• Oral

There is limited information regarding Monitoring of Bismuth subsalicylate in the drug label.

There is limited information regarding IV Compatibility of Bismuth subsalicylate in the drug label.

There is limited information regarding Overdose of Bismuth subsalicylate in the drug label.

Bismuth subsalicylate
Systematic (IUPAC) name
2-Hydroxy-2H,4H-benzo[d]1,3-dioxa-2-bismacyclohexan-4-one
Identifiers
CAS number	14882-18-9
ATC code	none
PubChem	16682734
DrugBank	DB01294
Chemical data
Formula	Template:OrganicBox atomTemplate:OrganicBox atomTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBox atomTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBox
Mol. mass	362.093 g/mol
SMILES	eMolecules & PubChem
Pharmacokinetic data
Bioavailability	?
Metabolism	?
Half life	?
Excretion	?
Therapeutic considerations
Pregnancy cat.	?
Legal status	OTC(US)
Routes	Oral

There is limited information regarding Bismuth subsalicylate Mechanism of Action in the drug label.

• Bismuth subsalicylate 262 mg

• (total salicylate 102 mg per tablet)

• calcium carbonate, D and C red 27 aluminum lake, flavor, magnesium stearate, mannitol, pregelatinized starch, saccharin sodium.

There is limited information regarding Pharmacodynamics of Bismuth subsalicylate in the drug label.

There is limited information regarding Pharmacokinetics of Bismuth subsalicylate in the drug label.

There is limited information regarding Nonclinical Toxicology of Bismuth subsalicylate in the drug label.

There is limited information regarding Clinical Studies of Bismuth subsalicylate in the drug label.

There is limited information regarding Bismuth subsalicylate How Supplied in the drug label.

• avoid excessive heat (over 104˚F or 40˚C)

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There is limited information regarding Patient Counseling Information of Bismuth subsalicylate in the drug label.

• Alcohol-Bismuth subsalicylate interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

• BISMATROL®^[1]

There is limited information regarding Bismuth subsalicylate Look-Alike Drug Names in the drug label.

The contents of this FDA label are provided by the National Library of Medicine.

 |Page Name=Bismuth subsalicylate
 |Pill Name=Pink_Bismuth_NDC_06030235.jpg
 |Drug Name=Pink Bismuth
 |Pill Ingred=BISMUTH SUBSALICYLATE[BISMUTH CATION]|+sep=;
 |Pill Imprint=RH046
 |Pill Dosage=262 mg
 |Pill Color=Pink|+sep=;
 |Pill Shape=Round
 |Pill Size (mm)=15
 |Pill Scoring=1
 |Pill Image=
 |Drug Author=Qualitest Pharmaceuticals
 |NDC=06030235