NDC 63187-650 Bismatrol
Bismuth Subsalicylate Tablet, Chewable Oral
Product Information
What is NDC 63187-650?
The NDC code 63187-650 is assigned by the FDA to the product Bismatrol which is a human over the counter drug product labeled by Proficient Rx Lp. The generic name of Bismatrol is bismuth subsalicylate. The product's dosage form is tablet, chewable and is administered via oral form. The product is distributed in a single package with assigned NDC code 63187-650-30 5 blister pack in 1 carton / 6 tablet, chewable in 1 blister pack. This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information, RxNorm crosswalk and the complete product label.
What are the uses for Bismatrol?
This medication is used to treat occasional upset stomach, heartburn, and nausea. It is also used to treat diarrhea and help prevent travelers' diarrhea. It works by helping to slow the growth of bacteria that might be causing the diarrhea. This product should not be used to self-treat diarrhea if you also have a fever or blood/mucus in the stools. These could be signs of a serious health condition. Consult your doctor promptly for proper evaluation and treatment if you have these symptoms. This medication is used under a doctor's direction with other medication to treat stomach ulcers caused by a certain bacteria (Helicobacter pylori). Do not use this medication to self-treat ulcers. Bismuth subsalicylate is a salicylate. Salicylates can cause serious bleeding problems when used alone in patients with ulcers. Check the ingredients on the label even if you have used the product before. The manufacturer may have changed the ingredients. Also, products with similar names may contain different ingredients meant for different purposes. Taking the wrong product could harm you.
Product Characteristics
Color(s) | PINK (C48328) |
Shape | ROUND (C48348) |
Size(s) | 17 MM |
Imprint(s) | GDC122 |
Score | 1 |
Product Packages
NDC Code 63187-650-30
Package Description: 5 BLISTER PACK in 1 CARTON / 6 TABLET, CHEWABLE in 1 BLISTER PACK
Product Details
What are Bismatrol Active Ingredients?
Bismatrol Active Ingredients UNII Codes
- BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1)
- BISMUTH CATION (UNII: ZS9CD1I8YE) (Active Moiety)
NDC to RxNorm Crosswalk
- RxCUI: 308761 - bismuth subsalicylate 262 MG Chewable Tablet
Bismatrol Inactive Ingredients UNII Codes
- CALCIUM CARBONATE (UNII: H0G9379FGK)
- D&C RED NO. 27 (UNII: 2LRS185U6K)
- MAGNESIUM STEARATE (UNII: 70097M6I30)
- MANNITOL (UNII: 3OWL53L36A)
- STARCH, CORN (UNII: O8232NY3SJ)
- SACCHARIN SODIUM (UNII: SB8ZUX40TY)
Pharmacologic Class(es)
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Patient Education
Bismuth Subsalicylate
Bismuth Subsalicylate is pronounced as (biz muth) (sub sa lis' i late)
Why is bismuth subsalicylate medication prescribed?
Bismuth subsalicylate is used to treat diarrhea, heartburn, and upset stomach in adults and children 12 years of age and older. Bismuth subsalicylate is in a class of med...
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Bismatrol Product Label
FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.
Product Label Table of Contents
- ACTIVE INGREDIENT (IN EACH TABLET)
- PURPOSE
- USES
- WARNINGS
- DO NOT USE IF YOU HAVE
- ASK A DOCTOR BEFORE USE IF YOU HAVE
- ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
- WHEN USING THIS PRODUCT
- STOP USE AND ASK A DOCTOR IF
- KEEP OUT OF REACH OF CHILDREN
- DIRECTIONS
- INACTIVE INGREDIENTS
- PRINCIPAL DISPLAY PANEL
Active Ingredient (In Each Tablet)
Bismuth subsalicylate 262 mg
(total salicylate 102 mg per tablet)
Purpose
Upset stomach reliever and anti-diarrheal
Uses
relieves:
• diarrhea• heartburn• indigestion• nausea• upset stomach associated with these symptoms
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
• 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 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
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.
Directions
• 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.• 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.
Other information: each tablet contains:
Inactive Ingredients
calcium carbonate, D and C red 27 aluminum lake, flavor, magnesium stearate, mannitol, pregelatinized starch, saccharin sodium.
Principal Display Panel
MAJOR
Relabeled by:
Proficient Rx LP
Thousand Oaks, CA 91320
Bismatrol Chewable Tablets
soothing, coating action provides fast relief for heartburn, indigestion, nausea, upset stomach and diarrhea
compare to the active ingredient in Pepto-Bismol®
30 chewable tablets
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