Regular Strength Stomach Relief Drug Facts

Regular Strength Stomach Relief Drug Facts
SPL v2
SPL
SPL Set ID 7d6047a9-5557-487a-ae06-f904dac626c9
Route
ORAL
Published
Effective Date 2024-11-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (525 mg)
Inactive Ingredients
Carboxymethylcellulose Sodium, Unspecified D&c Red No. 22 D&c Red No. 28 Microcrystalline Cellulose Potassium Hydroxide Potassium Sorbate Water Salicylic Acid Dimethicone, Unspecified Sodium Benzoate Sucralose Xanthan Gum Gellan Gum (high Acyl)

Identifiers & Packaging

Pill Appearance
Color: pink
Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-10-21

Description

Bismuth subsalicylate 525 mg

Purpose

Upset stomach reliever and antidiarrheal


Medication Information

Purpose

Upset stomach reliever and antidiarrheal

Description

Bismuth subsalicylate 525 mg

Uses

relieves

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

Upset stomach reliever and antidiarrheal

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
  • shake well before use
  • Only use dose cup provided
  • adults and children 12 years and over:30 mL (1 dose) every ½ hour or 60 mL (2 doses) every hour as needed for diarrhea/traveler’s diarrhea
  • 30 mL (1 dose) every ½ hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea)
  • do not exceed 8 doses (240 mL) 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
Do Not Use

if you have

  • an ulcer
  • a bleeding problem
  • bloody or black stool
Other Information
  • each 30 mL contains: potassium 14 mg, sodium 10 mg
  • salicylate 260 mg
  • low sodium
  • sugar free
  • store at room temperature
  • protect from freezing
  • avoid excessive heat (more than over 104°F or 40°C).
Inactive Ingredients

carboxymethylcellulose sodium, D&C red #22, D&C red #28, flavor, gellan gum, microcrystalline cellulose, potassium hydroxide, potassium sorbate, purified water, salicylic acid, Simethicone emulsion, sodium benzoate, sucralose, xanthan gum

Questions Or Comments?

1-866-467-2748

Safety Sealed: DO NOT USE IF IMPRINTED SHRINK BAND IS MISSING OR BROKEN

Principal Display Panel

NDC 70000-0698-1

COMPARE TO PEPTO-BISMOL® ORIGINAL LIQUID active ingredient*

LEADER™

Regular Strength

Stomach Relief

Bismuth Subsalicylate, 525 mg

Upset Stomach Reliever/Antidiarrheal

Original Flavor

Relieves:

  • Nausea
  • Heartburn
  • Indigestion
  • Upset Stomach
  • Diarrhea

8 FL OZ (236 mL)

100% Money Back Guarantee

Dist. By CAH DUBLIN, OH 43017

www.myleader.com

1-800-200-6313

©2024 Cardinal Health.

*This product is not manufactured or distributed by Procter & Gamble, distributor of Pepto-Bismol ®Original Liquid.

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
If Pregnant Or Breast Feeding,

ask a health professional before use.

Keep Out of Reach of Children.

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Ask A Doctor Before Use If You Have
  • fever
  • mucus in the stool
Active Ingredient (in Each 30 Ml Dose )

Bismuth subsalicylate 525 mg

Ask A Doctor Or Pharmacist Before Use If You Are

taking any drug for

  • anticoagulation (thinning 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
Purposes

Upset stomach reliever and antidiarrheal

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
  • shake well before use
  • Only use dose cup provided
  • adults and children 12 years and over:30 mL (1 dose) every ½ hour or 60 mL (2 doses) every hour as needed for diarrhea/traveler’s diarrhea
  • 30 mL (1 dose) every ½ hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea)
  • do not exceed 8 doses (240 mL) 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
Do Not Use (Do not use)

if you have

  • an ulcer
  • a bleeding problem
  • bloody or black stool
Other Information (Other information)
  • each 30 mL contains: potassium 14 mg, sodium 10 mg
  • salicylate 260 mg
  • low sodium
  • sugar free
  • store at room temperature
  • protect from freezing
  • avoid excessive heat (more than over 104°F or 40°C).
Inactive Ingredients (Inactive ingredients)

carboxymethylcellulose sodium, D&C red #22, D&C red #28, flavor, gellan gum, microcrystalline cellulose, potassium hydroxide, potassium sorbate, purified water, salicylic acid, Simethicone emulsion, sodium benzoate, sucralose, xanthan gum

Questions Or Comments? (Questions or comments?)

1-866-467-2748

Safety Sealed: DO NOT USE IF IMPRINTED SHRINK BAND IS MISSING OR BROKEN

Principal Display Panel

NDC 70000-0698-1

COMPARE TO PEPTO-BISMOL® ORIGINAL LIQUID active ingredient*

LEADER™

Regular Strength

Stomach Relief

Bismuth Subsalicylate, 525 mg

Upset Stomach Reliever/Antidiarrheal

Original Flavor

Relieves:

  • Nausea
  • Heartburn
  • Indigestion
  • Upset Stomach
  • Diarrhea

8 FL OZ (236 mL)

100% Money Back Guarantee

Dist. By CAH DUBLIN, OH 43017

www.myleader.com

1-800-200-6313

©2024 Cardinal Health.

*This product is not manufactured or distributed by Procter & Gamble, distributor of Pepto-Bismol ®Original Liquid.

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
If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of Reach of Children. (Keep out of reach of children.)

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • fever
  • mucus in the stool
Active Ingredient (in Each 30 Ml Dose ) (Active ingredient (in each 30 mL dose ))

Bismuth subsalicylate 525 mg

Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)

taking any drug for

  • anticoagulation (thinning the blood)
  • diabetes
  • gout
  • arthritis

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)