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NDC 63187-0651-08 Bismatrol 262 mg/15mL Details
Bismatrol 262 mg/15mL
Bismatrol is a ORAL LIQUID 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: 63187-0651-08Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Bismuth Subsalicylate
Product Information
| NDC | 63187-0651 |
|---|---|
| Product ID | 63187-651_1f21f520-fee9-4006-a20f-45128152a2b7 |
| 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 | LIQUID |
| Route | ORAL |
| Active Ingredient Strength | 262 |
| Active Ingredient Units | mg/15mL |
| 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 63187-0651-08 (63187065108)
| NDC Package Code | 63187-651-08 |
|---|---|
| Billing NDC | 63187065108 |
| Package | 236 mL in 1 BOTTLE (63187-651-08) |
| Marketing Start Date | 2018-12-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 6510a588-f2dc-4a71-aef0-b8fbe8fd615b Details
Uses
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
Ask a doctor or pharmacist before use if you are
taking any drug for
- •
- anticoagulation (thinning of 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
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
Other information
Inactive ingredients
Principal Display Panel
INGREDIENTS AND APPEARANCE
| BISMATROL
bismuth subsalicylate liquid |
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| Labeler - Proficient Rx LP (079196022) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Proficient Rx LP | 079196022 | RELABEL(63187-651) | |