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NDC 37000-0478-24 Pepto-Bismol 525 mg/1 Details
Pepto-Bismol 525 mg/1
Pepto-Bismol is a ORAL TABLET in the HUMAN OTC DRUG category. It is labeled and distributed by The Procter & Gamble Manufacturing Company. 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: 37000-0478-24Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Bismuth Subsalicylate
Product Information
| NDC | 37000-0478 |
|---|---|
| Product ID | 37000-478_e4cf772a-65c3-23d9-e053-2995a90a1df6 |
| Associated GPIs | 47300025000100 |
| GCN Sequence Number | 063904 |
| GCN Sequence Number Description | Bifidobacterium infantis CAPSULE 4 MG ORAL |
| HIC3 | D4D |
| HIC3 Description | ANTIDIARRHEAL MICROORGANISMS AGENTS |
| GCN | 99616 |
| HICL Sequence Number | 001252 |
| HICL Sequence Number Description | BIFIDOBACTERIUM INFANTIS |
| Brand/Generic | Brand |
| Proprietary Name | Pepto-Bismol |
| Proprietary Name Suffix | ULTRA |
| Non-Proprietary Name | Bismuth subsalicylate |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | TABLET |
| Route | ORAL |
| Active Ingredient Strength | 525 |
| Active Ingredient Units | mg/1 |
| Substance Name | BISMUTH SUBSALICYLATE |
| Labeler Name | The Procter & Gamble Manufacturing Company |
| Pharmaceutical Class | n/a |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH FINAL |
| Application Number | M008 |
| Listing Certified Through | 2023-12-31 |
Package
Package Images
NDC 37000-0478-24 (37000047824)
| NDC Package Code | 37000-478-24 |
|---|---|
| Billing NDC | 37000047824 |
| Package | 1 BOTTLE in 1 CARTON (37000-478-24) / 24 TABLET in 1 BOTTLE |
| Marketing Start Date | 2020-01-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 63274378-fbe1-63b1-e053-2a91aa0ae1a7 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 the blood)
- diabetes
- gout
- arthritis
Directions
- swallow with water, do not chew
- adults and children 12 years and over: 1 caplet (1 dose) every ½ hour or 2 caplets (2 doses) every hour as needed for diarrhea
- 1 caplet (1 dose) every ½ hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea)
- do not exceed 8 doses (8 caplets) 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 - 24 Caplet Carton
INGREDIENTS AND APPEARANCE
| PEPTO-BISMOL
ULTRA
bismuth subsalicylate tablet |
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| Labeler - The Procter & Gamble Manufacturing Company (004238200) |