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NDC 54738-0102-30 Pepto Relief 262 mg/1 Details
Pepto Relief 262 mg/1
Pepto Relief is a ORAL TABLET, CHEWABLE in the HUMAN OTC DRUG category. It is labeled and distributed by Richmond Pharmaceuticals, Inc. 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: 54738-0102-30Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Bismuth Subsalicylate
Product Information
| NDC | 54738-0102 |
|---|---|
| Product ID | 54738-102_5cc53a8f-4daa-7cff-e053-2991aa0a383b |
| Associated GPIs | 47300010000507 |
| GCN Sequence Number | 002860 |
| GCN Sequence Number Description | bismuth subsalicylate TAB CHEW 262 MG ORAL |
| HIC3 | D6D |
| HIC3 Description | ANTIDIARRHEALS |
| GCN | 08420 |
| HICL Sequence Number | 001246 |
| HICL Sequence Number Description | BISMUTH SUBSALICYLATE |
| Brand/Generic | Generic |
| Proprietary Name | Pepto Relief |
| 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 | Richmond Pharmaceuticals, Inc |
| 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 54738-0102-30 (54738010230)
| NDC Package Code | 54738-102-30 |
|---|---|
| Billing NDC | 54738010230 |
| Package | 30 TABLET, CHEWABLE in 1 BOTTLE (54738-102-30) |
| Marketing Start Date | 2015-06-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL a6f383b4-47f9-4837-93e2-2ca114fb20b9 Details
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: 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
- If you have an ulcer or 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 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.
Directions
Other Information
INACTIVE INGREDIENT
Questions or Comments
INGREDIENTS AND APPEARANCE
| PEPTO RELIEF
bismuth subsalicylate tablet, chewable |
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| Labeler - Richmond Pharmaceuticals, Inc (043569607) |
| Registrant - Advance Pharmaceutical Inc. (078301063) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Advance Pharmaceutical Inc. | 078301063 | manufacture(54738-102) | |