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| Product NDC Code | 69842-799 | ||||
|---|---|---|---|---|---|
| Drug Name | Bismuth subsalicylate |
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| Type | Generic | ||||
| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | CAPSULE, GELATIN COATED | ||||
| RxCUI drug identifier | 2121072 | ||||
| Application Number | M008 | ||||
| Labeler Name | CVS PHARMACY, INC. | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient ( in each softgel) Purpose Bismuth subsalicylate 262 mg ................Upset stomach reliever and anti-diarrheal
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.Directions swallow with water, do not chew adults and children 12 years and over: 2 softgels every ½ hour or 4 softgels every hour as needed for diarrhea 2 softgels every ½ hour to 1 hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea) do not exceed 8 doses (16 softgels) 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 by diarrhea
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients aerosil, beeswax, FD&C Red#33, FD&C Yellow#6, gelatin, glycerin, light liquid paraffin, purified water, soya lecithin, sodium carboxy methyl cellulose, sorbitol solution, titanium dioxide
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Uses relieves travelers' diarrhea diarrhea upset stomach due to overindulgence in food and drink, including: heartburn, indigestion, nausea, gas, belching fullness
Purpose
Information about the drug product’s indications for use.Active ingredient ( in each softgel) Purpose Bismuth subsalicylate 262 mg ................Upset stomach reliever and anti-diarrheal
Spl product data elements
Usually a list of ingredients in a drug product.Bismuth Subsalicylate Bismuth Subsalicylate SILICON DIOXIDE LECITHIN, SOYBEAN YELLOW WAX CARBOXYMETHYLCELLULOSE SODIUM LIGHT MINERAL OIL GELATIN GLYCERIN D&C RED NO. 33 FD&C YELLOW NO. 6 TITANIUM DIOXIDE WATER BISMUTH SUBSALICYLATE SALICYLIC ACID 262
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.PRINCIPAL DISPLAY PANEL Stomach Relief BISMUTH SUBSALICYLATE 262 mg Upset stomach reliever/Antidiarrheal Soothing relief for 5 symptoms: • Heartburn • Indigestion • Upset stomach • Nausea • Diarrhea 12 SOFTGELS image description
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Drug Facts
Ask doctor
Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.Ask a doctor before use if you have fever mucus in the stool
Ask doctor or pharmacist
Information about when a doctor or pharmacist should be consulted about drug/drug or drug/food interactions before using a drug product.Ask a doctor or pharmacist before use if you are taking any drug for anticoagulation (thinning the blood) diabetes gout arthritis
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.Do not use if you have an ulcer a bleeding problem bloody or black stool
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions or comments? 1-888-333-9792
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.Stop use and ask a doctor if symptoms get worse or last more than 2 days ringing in the ears or loss of hearing occurs diarrhea lasts more than 2 days
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.When using this product a temporary, but harmless, darkening of the stool and/or tongue may occur
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast-feeding, ask a health professional before use.
Storage and handling
Information about safe storage and handling of the drug product.Other information each softgel contains: salicylate 102.33 mg very low sodium do not exceed 25°C
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.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 before use if you are taking any drug for anticoagulation (thinning 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 or last more than 2 days 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.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API