Premier Value Bismuth Subsalicylate 30 Chewable Tablets

Premier Value Bismuth Subsalicylate 30 Chewable Tablets
SPL v6
SPL
SPL Set ID 3b8850e8-f9c2-4d52-aadd-8e037fabdee4
Route
ORAL
Published
Effective Date 2024-10-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (262 mg)
Inactive Ingredients
D&c Red No. 27 Magnesium Stearate Maltodextrin Microcrystalline Cellulose Sorbitol Sucralose

Identifiers & Packaging

Pill Appearance
Imprint: RP124 Shape: round Color: pink Size: 17 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-05-22

Description

Bismuth subsalicylate 262 mg

Purpose

Anti-diarrheal/ upset stomach reliever


Medication Information

Purpose

Anti-diarrheal/ upset stomach reliever

Description

Bismuth subsalicylate 262 mg

Uses

relieves:

  • travelers’ diarrhea
  • diarrhea
  • upset stomach due to overindulgence in food and drink, including:
  • heartburn
  • indigestion
  • nausea
  • gas
  • belching
  • fullness
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
Directions
  • chew completely or dissolve tablets in mouth. Do not swallow tablets whole.
  • adults and children 12 years and older:
  • 2 tablets (1 dose) every 1/2 hour or 4 tablets (2 doses) every hour as needed for diarrhea
  • 2 tablets (1 dose) every ½ hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea)
  • do not exceed 8 doses (16 tablets) 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
  • each tablet contains: salicylate 102 mg
  • store at room temperature.
  • avoid excessive heat

TAMPER EVIDENT: Do not use if printed inner wrap is broken or missing.

Principal Display

Premier Value®

NDC# 68016-124-30

COMPARE TO THE ACTIVE INGREDIENT PEPTO-BISMOL®

PINK BISMUTH

Bismuth Subsalicylate 262 mg

Provides soothing Relief for:

  • Upset stomach
  • Indigestion
  • Nausea
  • Heartburn
  • Diarrhea

30 CHEWABLE TABLETS

Manufactured For Your Military Exchanges

Distributed By:

Pharmacy Value Alliance, LLC

407 East Lancaster Avenue,

Wayne, PA 19087

*This product is not manufactured or distributed by The Procter & Gamble Inc., owner of the registered trademark Pepto-Bismol®.

If any reason you are not satisfied with this product, please return it to the store where purchased for a full refund.

Inactive Ingredients

D&C Red No. 27 lake, flavor, magnesium stearate, maltodextrin, microcrystalline cellulose, sorbitol, sucralose.

Do Not Use If You Have
  • an ulcer
  • a bleeding problem
  • bloody or black stool
Questions Or Comments?

1-866-467-2748

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 or last more than 2 days
  • ringing in the ears or loss of hearing occurs
  • diarrhea lasts more than 2 days
Keep Out of Reach of Children

In case of overdose, get medical help or contact a Poison Control Center immediately at 1-800-222-1222

Active Ingredient (in Each Tablet)

Bismuth subsalicylate 262 mg

Ask A Doctor Before Use If You Have
  • fever
  • mucus in the stool
Ask A Doctor Or Pharmacist Before Use If You Are
  • anticoagulation (thinning of the blood)
  • diabetes
  • gout
  • arthritis

Structured Label Content

Uses

relieves:

  • travelers’ diarrhea
  • diarrhea
  • upset stomach due to overindulgence in food and drink, including:
  • heartburn
  • indigestion
  • nausea
  • gas
  • belching
  • fullness
Purpose

Anti-diarrheal/ upset stomach reliever

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
Directions
  • chew completely or dissolve tablets in mouth. Do not swallow tablets whole.
  • adults and children 12 years and older:
  • 2 tablets (1 dose) every 1/2 hour or 4 tablets (2 doses) every hour as needed for diarrhea
  • 2 tablets (1 dose) every ½ hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea)
  • do not exceed 8 doses (16 tablets) 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 (Other information)
  • each tablet contains: salicylate 102 mg
  • store at room temperature.
  • avoid excessive heat

TAMPER EVIDENT: Do not use if printed inner wrap is broken or missing.

Principal Display

Premier Value®

NDC# 68016-124-30

COMPARE TO THE ACTIVE INGREDIENT PEPTO-BISMOL®

PINK BISMUTH

Bismuth Subsalicylate 262 mg

Provides soothing Relief for:

  • Upset stomach
  • Indigestion
  • Nausea
  • Heartburn
  • Diarrhea

30 CHEWABLE TABLETS

Manufactured For Your Military Exchanges

Distributed By:

Pharmacy Value Alliance, LLC

407 East Lancaster Avenue,

Wayne, PA 19087

*This product is not manufactured or distributed by The Procter & Gamble Inc., owner of the registered trademark Pepto-Bismol®.

If any reason you are not satisfied with this product, please return it to the store where purchased for a full refund.

Inactive Ingredients (Inactive ingredients)

D&C Red No. 27 lake, flavor, magnesium stearate, maltodextrin, microcrystalline cellulose, sorbitol, sucralose.

Do Not Use If You Have (Do not use if you have)
  • an ulcer
  • a bleeding problem
  • bloody or black stool
Questions Or Comments? (Questions or comments?)

1-866-467-2748

When Using This Product (When using this product)

a temporary, but harmless, darkening of the stool and/or tongue may occur.

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • symptoms get worse or last more than 2 days
  • ringing in the ears or loss of hearing occurs
  • diarrhea lasts more than 2 days
Keep Out of Reach of Children

In case of overdose, get medical help or contact a Poison Control Center immediately at 1-800-222-1222

Active Ingredient (in Each Tablet) (Active ingredient (in each tablet))

Bismuth subsalicylate 262 mg

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • fever
  • mucus in the stool
Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)
  • anticoagulation (thinning of the blood)
  • diabetes
  • gout
  • arthritis

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)