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| Product NDC Code | 63187-651 | ||||
|---|---|---|---|---|---|
| Drug Name | Bismatrol |
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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 | LIQUID | ||||
| RxCUI drug identifier | 308762 | ||||
| Application Number | part335 | ||||
| Labeler Name | Proficient Rx LP | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient (in each 15 mL tbsp) Bismuth subsalicylate 262 mg
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 • 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 by diarrhea
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients benzoic acid, D and C red 22, D and C red 28, flavor, hydroxy ethyl cellulose, potassium hydroxide, purified water, saccharin sodium, salicylic acid, simethicone, xanthan gum.
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: • diarrhea • heartburn • indigestion • nausea • upset stomach associated with these symptoms
Purpose
Information about the drug product’s indications for use.Purpose Upset stomach reliever and anti-diarrheal
Spl product data elements
Usually a list of ingredients in a drug product.Bismatrol Bismuth Subsalicylate BISMUTH SUBSALICYLATE BISMUTH CATION BENZOIC ACID D&C RED NO. 22 D&C RED NO. 28 HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%) POTASSIUM HYDROXIDE WATER SACCHARIN SODIUM SALICYLIC ACID DIMETHICONE XANTHAN GUM
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 Bismatrol soothing, coating action provides fast relief for heartburn, indigestion, nausea, upset stomach and diarrhea compare to the active ingredient in pepto-bismol ® 8 FL OZ (236 mL) Relabeled by: Proficient Rx LP Thousand Oaks, CA 91320 63187-651-08
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 of 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 • bloody or black stool • an ulcer • a bleeding problem
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 Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately.
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. Keep out of reach of children. In case of overdose, get medical help or contact a Poison control center immediately.
Storage and handling
Information about safe storage and handling of the drug product.Other information • each Tbsp contains: sodium 5 mg, salicylate 130 mg, potassium 15 mg • protect from freezing • avoid excessive heat (over 104 o F or 40 o C) • TAMPER EVIDENT:Do not use if imprinted shrinkband is missing or broken .
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 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. Keep Out of Reach of Children Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately.
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