Drug Facts

Drug Facts
SPL v8
SPL
SPL Set ID 90b0c541-2834-4ed7-9d01-76080dd73057
Route
ORAL
Published
Effective Date 2024-06-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (525 mg)
Inactive Ingredients
Benzoic Acid D&c Red No. 22 D&c Red No. 28 Magnesium Aluminum Silicate Water Saccharin Sodium Salicylic Acid Sodium Salicylate Sorbic Acid Methylcellulose (1500 Cps)

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2018-07-31

Description

Bismuth subsalicylate 525 mg

Purpose

Upset stomach reliever/Antidiarrheal


Medication Information

Purpose

Upset stomach reliever/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
    • fullness
    • belching
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
Directions
  • shake well before using
  • mL = milliliter
  • measure only with dosing cup provided. do not use any other dosng device.
  • keep dosing cup with product
  • adults and children 12 years and over
    • 30 mL (1 dose) every 1/2 to 1 hour as needed
    • do not exceed 8 doses (240 mL) in 24 hours
    • use until diarrhea stops but not more than 2 days
  • children under 12 years of age: 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
Questions?

Call 1-800-910-6874

Package Label
TARGET Digestive Relief
Other Information
  • each 30 mL contains: potassium 8 mg sodium 9 mg
  • each 30 mL contains: salicylate 243 mg
  • low sodium
  • keep tightly closed
  • protect from freezing
  • avoid excessive heat (over 104ºF or 40ºC)
Inactive Ingredients

benzoic acid, D&C red #22, D&C red #28, flavor, magnesium aluminum silicate, methylcellulose, purified water, saccharin sodium, salicylic acid, sodium salicylate, sorbic acid

Principal Display Panel

Compare to the active ingredient in Pepto-Bismol®*

5-symptom

digestive relief

Bismuth subsalicylate 525 mg per 30 mL

upset stomach reliever/antidiarrheal

Soothing relief of heartburn, indigestion, nausea,

upset stomach and diarrhea

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.

Dist. by Target Corp.,

Mpls., MN 55403

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 Childen.

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

If Pregnant Or Breast Feeding,

ask a health professional before use.

Active Ingredient (in Each 30 Ml)

Bismuth subsalicylate 525 mg

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

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

Structured Label Content

Uses

relieves

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

Upset stomach reliever/Antidiarrheal

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
Directions
  • shake well before using
  • mL = milliliter
  • measure only with dosing cup provided. do not use any other dosng device.
  • keep dosing cup with product
  • adults and children 12 years and over
    • 30 mL (1 dose) every 1/2 to 1 hour as needed
    • do not exceed 8 doses (240 mL) in 24 hours
    • use until diarrhea stops but not more than 2 days
  • children under 12 years of age: 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
Questions?

Call 1-800-910-6874

Package Label
TARGET Digestive Relief
Other Information (Other information)
  • each 30 mL contains: potassium 8 mg sodium 9 mg
  • each 30 mL contains: salicylate 243 mg
  • low sodium
  • keep tightly closed
  • protect from freezing
  • avoid excessive heat (over 104ºF or 40ºC)
Inactive Ingredients (Inactive ingredients)

benzoic acid, D&C red #22, D&C red #28, flavor, magnesium aluminum silicate, methylcellulose, purified water, saccharin sodium, salicylic acid, sodium salicylate, sorbic acid

Principal Display Panel

Compare to the active ingredient in Pepto-Bismol®*

5-symptom

digestive relief

Bismuth subsalicylate 525 mg per 30 mL

upset stomach reliever/antidiarrheal

Soothing relief of heartburn, indigestion, nausea,

upset stomach and diarrhea

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.

Dist. by Target Corp.,

Mpls., MN 55403

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 Childen. (Keep out of reach of childen.)

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

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

ask a health professional before use.

Active Ingredient (in Each 30 Ml) (Active ingredient (in each 30 mL))

Bismuth subsalicylate 525 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)

taking any drug for

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

Advanced Ingredient Data


Raw Label Data

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