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NDC 63187-0650-30 Bismatrol 262 mg/1 Details
Bismatrol 262 mg/1
Bismatrol is a ORAL TABLET, CHEWABLE in the HUMAN OTC DRUG category. It is labeled and distributed by Proficient Rx LP. The primary component is BISMUTH SUBSALICYLATE.
MedlinePlus Drug Summary
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 medications called antidiarrheal agents. It works by decreasing the flow of fluids and electrolytes into the bowel, reduces inflammation within the intestine, and may kill the organisms that can cause diarrhea.
Related Packages: 63187-0650-30Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Bismuth Subsalicylate
Product Information
| NDC | 63187-0650 |
|---|---|
| Product ID | 63187-650_81b530d1-1156-4106-a003-0caadb83839f |
| Associated GPIs | |
| GCN Sequence Number | n/a |
| GCN Sequence Number Description | n/a |
| HIC3 | n/a |
| HIC3 Description | n/a |
| GCN | n/a |
| HICL Sequence Number | n/a |
| HICL Sequence Number Description | n/a |
| Brand/Generic | n/a |
| Proprietary Name | Bismatrol |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Bismuth subsalicylate |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | TABLET, CHEWABLE |
| Route | ORAL |
| Active Ingredient Strength | 262 |
| Active Ingredient Units | mg/1 |
| Substance Name | BISMUTH SUBSALICYLATE |
| Labeler Name | Proficient Rx LP |
| Pharmaceutical Class | Bismuth [CS], Bismuth [EPC] |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH FINAL |
| Application Number | part335 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 63187-0650-30 (63187065030)
| NDC Package Code | 63187-650-30 |
|---|---|
| Billing NDC | 63187065030 |
| Package | 5 BLISTER PACK in 1 CARTON (63187-650-30) / 6 TABLET, CHEWABLE in 1 BLISTER PACK |
| Marketing Start Date | 2018-12-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 003dbf85-8eb3-4587-944b-62c274b81172 Details
Uses
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
Ask a doctor or pharmacist before use if you are
taking any drug for
- •
- anticoagulation (thinning of the blood)
- •
- diabetes
- •
- gout
- •
- arthritis
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.
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.
Inactive ingredients
Principal Display Panel
INGREDIENTS AND APPEARANCE
| BISMATROL
bismuth subsalicylate tablet, chewable |
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| Labeler - Proficient Rx LP (079196022) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Proficient Rx LP | 079196022 | RELABEL(63187-650) | |