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| Product NDC Code | 48433-127 | ||||
|---|---|---|---|---|---|
| Drug Name | Bismuth |
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| Type | Brand | ||||
| Pharm Class | Bismuth [CS], Bismuth [EPC] |
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| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | TABLET | ||||
| RxCUI drug identifier | 308761 | ||||
| Application Number | part335 | ||||
| Labeler Name | Safecor Health, LLC | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Bismuth subsalicylate 262 mg (each tablet contains 102 mg salicylate)
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 Chew or dissolve in mouth Adults and children 12 years and over : 2 tablets (1 dose) every ½ hour or 4 tablets (2 doses) every hour as needed for diarrhea 2 tablets (1 dose) every ½ hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea) Do not exceed 8 doses (16 tablets) in 24 hours Use until diarrhea stops but no more than 2 days Children under 12 years of age: ask a doctor Drink plenty of clear fluids to help prevent dehydration caused by diarrhea Other Information Phenylketonurics: contains phenylalanine 1.1 mg per tablet Calcium content per tablet: ·73 mg • save carton for full directions and warnings • store at room temperature 15°- 30°C (59°- 86°F)
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients acacia gum, aspartame, calcium carbonate, D&C red #27 aluminum lake, dextrates, magnesium stearate, maltodextrin, microcrystalline cellulose, peppermint flavor, silicon 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.Purpose Antidiarrheal/Antacid
Spl product data elements
Usually a list of ingredients in a drug product.Bismuth Bismuth subsalicylate BISMUTH SUBSALICYLATE BISMUTH CATION ASPARTAME CALCIUM CARBONATE D&C RED NO. 27 DEXTRATES MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE SILICON DIOXIDE ACACIA MALTODEXTRIN PEPPERMINT RH046
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.Package/Label Principal Display Panel Bismuth Subsalicylate 262 mg Chewable Tablet Mfg: Allegiant Health Exp:02/03/24 Lot22A0016 PKG BY: Safecor Health Woburn, MA 4843312701 Safecor Label
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.BISMUTH SUBSALICYLATE 262 mg Chewable Tablet Contains 100 Unit Dose Blisters NDC: 48433-127-01 3 48433 127 10 0 GTIN: 00348433127100 SN: 222202401 Exp: 2024-03-27 Lot: 22A0078 These unit dose packages meet USP specifications for light resistance. The package design is not child resistant. For institutional use only. Distributed by Safecor Health, LLC 317 New Boston St, Woburn MA 01801 06/2022 PN5728
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 accidental overdose, contact a doctor or Poison Control Center (1-800-222-1222) right away.
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 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.
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 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.
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