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NDC 62011-0394-01 Stomach Relief 525 mg/15mL Details
Stomach Relief 525 mg/15mL
Stomach Relief is a ORAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by Strategic Sourcing Services LLC. 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: 62011-0394-01Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Bismuth Subsalicylate
Product Information
| NDC | 62011-0394 |
|---|---|
| Product ID | 62011-0394_7298724a-1dcb-4673-9899-1180a393c6df |
| Associated GPIs | 47300010001830 |
| GCN Sequence Number | 002859 |
| GCN Sequence Number Description | bismuth subsalicylate ORAL SUSP 525MG/15ML ORAL |
| HIC3 | D6D |
| HIC3 Description | ANTIDIARRHEALS |
| GCN | 26971 |
| HICL Sequence Number | 001246 |
| HICL Sequence Number Description | BISMUTH SUBSALICYLATE |
| Brand/Generic | Generic |
| Proprietary Name | Stomach Relief |
| Proprietary Name Suffix | Ultra |
| Non-Proprietary Name | Bismuth subsalicylate |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | LIQUID |
| Route | ORAL |
| Active Ingredient Strength | 525 |
| Active Ingredient Units | mg/15mL |
| Substance Name | BISMUTH SUBSALICYLATE |
| Labeler Name | Strategic Sourcing Services LLC |
| Pharmaceutical Class | Bismuth [CS], Bismuth [EPC] |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH FINAL |
| Application Number | part335 |
| Listing Certified Through | n/a |
Package
Package Images
NDC 62011-0394-01 (62011039401)
| NDC Package Code | 62011-0394-1 |
|---|---|
| Billing NDC | 62011039401 |
| Package | 237 mL in 1 BOTTLE, PLASTIC (62011-0394-1) |
| Marketing Start Date | 2018-12-31 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 64ff6f03-51a9-491d-abfa-1c4288c184f4 Details
Uses
Warnings
Reye's syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms ahould 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
- diabetes
- gout
- arthritis
- anticoagulation (thinning the blood)
Directions
- do not take more than 8 doses (120 mL) in 24 hours
- use until diarrhea stops but not more than 2 days
- drink plenty of clear fluids to help prevent dehydration caused by diarrhea
- mL = milliliter
- shake well before using
- measure only with dosing cup provided. Do not use any other dosing device
- keep dosing cup with product
- adults and children 12 years and over:
- 15 mL (1dose) every 1/2 or 30 mL (2 doses) every hour as needed diarrhea/traveler's diarrhea
- 15 mL (1 dose) every 1/2 hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea)
- children under 12 years of age: ask a doctor
Other information
Inactive ingredients
Principal Display Panel
Compare to active ingredient in Pepto-Bismol® Ultra†
ULTRA
Stomach Relief
Bismuth Subsalicylate 525 mg
Upset Stomach Reliever/Antidiarrheal
Relieves:
Heartburn, Indigestion, Nausea, Upset Stomach, Diarrhea
2x Strength Per Ounce*
Alcohol Free • Sugar Free
FL OZ (mL)
†This product is not manufactured or distributed by The Procter & Gamble Company. Pepto-Bismol® is a registered trademark of The Procter & Gamble Company.
TAMPER EVIDENT; DO NOT USE IF PRINTED SAFETY SEAL AROUND DOSAGE CUP OR UNDER CAP IS BROKEN OR MISSING.
Distributed by Mckesson
One Post Street, San Francisco, CA 94104
INGREDIENTS AND APPEARANCE
| STOMACH RELIEF
ULTRA
bismuth subsalicylate liquid |
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| Labeler - Strategic Sourcing Services LLC (116956644) |