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NDC 70000-0594-01 Bismuth Subsalicylate 262 mg/1 Details
Bismuth Subsalicylate 262 mg/1
Bismuth Subsalicylate is a ORAL TABLET, FILM COATED in the HUMAN OTC DRUG category. It is labeled and distributed by Cardinal Health. 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: 70000-0594-01Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Bismuth Subsalicylate
Product Information
| NDC | 70000-0594 |
|---|---|
| Product ID | 70000-0594_d4af6694-910d-da17-e053-2995a90a8454 |
| Associated GPIs | |
| GCN Sequence Number | 023160 |
| GCN Sequence Number Description | bismuth subsalicylate TABLET 262 MG ORAL |
| HIC3 | D6D |
| HIC3 Description | ANTIDIARRHEALS |
| GCN | 08421 |
| HICL Sequence Number | 001246 |
| HICL Sequence Number Description | BISMUTH SUBSALICYLATE |
| Brand/Generic | Generic |
| Proprietary Name | Bismuth Subsalicylate |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Bismuth Subsalicylate |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | TABLET, FILM COATED |
| Route | ORAL |
| Active Ingredient Strength | 262 |
| Active Ingredient Units | mg/1 |
| Substance Name | BISMUTH SUBSALICYLATE |
| Labeler Name | Cardinal Health |
| Pharmaceutical Class | n/a |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH FINAL |
| Application Number | part335 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 70000-0594-01 (70000059401)
| NDC Package Code | 70000-0594-1 |
|---|---|
| Billing NDC | 70000059401 |
| Package | 1 BOTTLE in 1 CARTON (70000-0594-1) / 24 TABLET, FILM COATED in 1 BOTTLE |
| Marketing Start Date | 2022-01-03 |
| NDC Exclude Flag | N |
| Pricing Information | |
| Price Per Unit | 0.08189 |
| Pricing Unit | EA |
| Effective Date | 2024-02-21 |
| NDC Description | STOMACH RELIEF 262 MG CAPLET |
| Pharmacy Type Indicator | C/I |
| OTC | Y |
| Explanation Code | 1 |
| Classification for Rate Setting | G |
| As of Date | 2024-02-21 |
Standard Product Labeling (SPL)/Prescribing Information SPL d4af6694-910c-da17-e053-2995a90a8454 Details
Uses
SPL UNCLASSIFIED SECTION
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 caplets with water, do not chew
adults and children 12 years and over:
- 2 caplets (1 dose) every 1/2 hour or 4 caplets (2 doses) every hour as needed for diarrhea
- 2 caplets (1 dose) every 1/2 hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea)
- do not exceed 8 doses (16 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
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
RETAIN THIS CARTON FOR FULL LABELING INFORMATION
WARNING: This product can expose you to chemicals including lead, which is known to the State of California to cause cancer and birth defects or other reproductive harm. For more information go to www.P65Warnings.ca.gov.
COMPARE TO PEPTO-BISMOL active ingredient*
*This product is not manufactured or distributed by Procter & Gamble Inc., the distributor of Pepto-Bismol®.
DISTRIBUTED BY CARDINAL HEALTH
DUBLIN, OHIO 43017
www.myleader.com
1-800-200-6313
Essential to Care™ since 1979
Product of Mexico
INGREDIENTS AND APPEARANCE
| BISMUTH SUBSALICYLATE
bismuth subsalicylate tablet, film coated |
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| Labeler - Cardinal Health (063997360) |