Good Sense  Maximum Strength Stomach Relief  528

Good Sense  Maximum Strength Stomach Relief  528
SPL v2
SPL
SPL Set ID 19a4191a-6196-f8ac-e063-6394a90a47ab
Route
ORAL
Published
Effective Date 2024-09-17
Document Type 34390-5 Human OTC Drug Label

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (1050 mg)
Inactive Ingredients
Benzoic Acid D&c Red No. 22 D&c Red No. 28 Potassium Hydroxide Water Saccharin Sodium Salicylic Acid Hydroxyethyl Cellulose (1500 Mpa.s At 1%) Dimethicone Xanthan Gum

Identifiers & Packaging

Pill Appearance
Color: pink
Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-09-13

Description

Bismuth subsalicylate 1050 mg

Purpose

Upset stomach reliever and anti-diarrheal


Medication Information

Purpose

Upset stomach reliever and anti-diarrheal

Description

Bismuth subsalicylate 1050 mg

Use(s)

relieves:



  • diarrhea
  • heartburn
  • indigestion
  • nausea
  • upset stomach associated with these symptoms
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
  • mL = milliliter
  • TBSP = tablespoon
  • adults and children 12 years and over: 1 dose (2 TBSP or 30 mL) every hour as needed
  • do not exceed 4 doses (8 TBSP or 120 mL) in 24 hours
  • use until diarrhea stops but not more than 2 days
  • children under 12 years: ask a doctor
  • drink plenty of fluids to help prevent dehydration caused by diarrhea
Other Information
  • each 30 mL or 2 TBSP contains:
  • potassium 15 mg
  • salicylate 471 mg
  • sodium 8 mg
  • protect from freezing
  • avoid excessive heat (over 104oF or 40oC)
  • dosage cup provided
Inactive Ingredients

benzoic acid, D&C red # 22, D&C red # 28, flavor, hydroxyethyl cellulose, potassium hydroxide, purified water, saccharin sodium, salicylic acid, simethicone, xanthan gum.

Do Not Use If You Have
  • an ulcer
  • bloody or black stool
  • a bleeding problem
Principal Display Panel

NDC 50804-154-04

GOODSENSE®

Maximum Strength

Stomach Relief

Bismuth Subsalicylate 1050 mg

Antidiarrheal /Upset Stomach Reliever

Soothing Relief For 5 Symptoms

  • Upset Stomach
  • Indigestion
  • Heartburn
  • Nausea
  • Diarrhea

*Compare to the active ingredient of Pepto-Bismol ® Maximum Strength

  8 FL OZ (236  mL)



When Using This Product

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

Stop Use and Ask Doctor If
  • symptoms get worse
  • 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.

If Pregnant Or Breast Feeding,

ask a health professional before use.

Active Ingredient(in Each 30 Ml)

Bismuth subsalicylate 1050 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 



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

Structured Label Content

Use(s) (USE(S))

relieves:



  • diarrhea
  • heartburn
  • indigestion
  • nausea
  • upset stomach associated with these symptoms
Purpose (PURPOSE)

Upset stomach reliever and anti-diarrheal

Warnings (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 (DIRECTIONS)
  • shake well before use
  • mL = milliliter
  • TBSP = tablespoon
  • adults and children 12 years and over: 1 dose (2 TBSP or 30 mL) every hour as needed
  • do not exceed 4 doses (8 TBSP or 120 mL) in 24 hours
  • use until diarrhea stops but not more than 2 days
  • children under 12 years: ask a doctor
  • drink plenty of fluids to help prevent dehydration caused by diarrhea
Other Information (OTHER INFORMATION)
  • each 30 mL or 2 TBSP contains:
  • potassium 15 mg
  • salicylate 471 mg
  • sodium 8 mg
  • protect from freezing
  • avoid excessive heat (over 104oF or 40oC)
  • dosage cup provided
Inactive Ingredients (INACTIVE INGREDIENTS)

benzoic acid, D&C red # 22, D&C red # 28, flavor, hydroxyethyl cellulose, potassium hydroxide, purified water, saccharin sodium, salicylic acid, simethicone, xanthan gum.

Do Not Use If You Have (DO NOT USE IF YOU HAVE)
  • an ulcer
  • bloody or black stool
  • a bleeding problem
Principal Display Panel (PRINCIPAL DISPLAY PANEL)

NDC 50804-154-04

GOODSENSE®

Maximum Strength

Stomach Relief

Bismuth Subsalicylate 1050 mg

Antidiarrheal /Upset Stomach Reliever

Soothing Relief For 5 Symptoms

  • Upset Stomach
  • Indigestion
  • Heartburn
  • Nausea
  • Diarrhea

*Compare to the active ingredient of Pepto-Bismol ® Maximum Strength

  8 FL OZ (236  mL)



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 Doctor If (STOP USE AND ASK DOCTOR IF)
  • symptoms get worse
  • ringing in the ears or loss of hearing occurs
  • diarrhea lasts more than 2 days
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 immediately.

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 1050 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 



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

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)