Maximum Strength Stomach Relief Liquid

Maximum Strength Stomach Relief Liquid
SPL v1
SPL
SPL Set ID f3323f03-eea3-49cf-acef-66873ae0eef2
Route
ORAL
Published
Effective Date 2014-11-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Bismuth Cation (525 mg)
Inactive Ingredients
Benzoic Acid D&c Red No. 22 D&c Red No. 28 Hydroxyethyl Cellulose (2000 Cps At 1%) Potassium Hydroxide Water Saccharin Sodium Dihydrate Salicylic Acid Dimethicone Xanthan Gum

Identifiers & Packaging

Pill Appearance
Color: pink
Marketing Status
OTC MONOGRAPH FINAL Active Since 2014-12-12

Description

Bismuth subsalicylate 525 mg

Purpose

Upset stomach reliever and anti-diarrheal


Medication Information

Purpose

Upset stomach reliever and anti-diarrheal

Description

Bismuth subsalicylate 525 mg

Uses

relieves:

  • diarrhea
  • heartburn
  • indigestion
  • nausea
  • upset stomach associated with these symptoms
Section 50565-1


Warnings

Reye's syndrome: Children and teenagers who have or are recovering from children 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
  • for accurate dosing, use dose cup
  • 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 clear fluids to help prevent dehydration caused by diarrhea

Other Information
  • each Tbsp contains: sodium 5 mg, salicylate 236 mg, potassium 15 mg
  • protect from freezing
  • avoid excessive heat (over 104oF or 40oC)
  • TAMPER EVIDENT: Do not use if imprinted shrinkband is missing or broken.
Inactive Ingredients

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

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

Principal Display Panel

*Compare to the active ingredient in PEPTO-BISMOL® Maximum Strength

Maximum Strength Stomach Relief

Bismuth Subsalicylate / Upset Stomach Reliever & Anti-diarrheal

Soothing Relief for: Upset Stomach, Indigestion, Nausea, Heartburn & Diarrhea

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 A Doctor If
  • symptoms get worse
  • ringing in the ears or loss of hearing occurs
  • diarrhea lasts more than 2 days

Ask A Doctor Before Use If You Have
  • fever
  • mucus in the stool

Active Ingredient (in Each 15 Ml Tbsp)

Bismuth subsalicylate 525 mg

Ask A Doctor Or Pharmacist Before Use If You Are Taking Any Drug For

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


Structured Label Content

Uses

relieves:

  • diarrhea
  • heartburn
  • indigestion
  • nausea
  • upset stomach associated with these symptoms
Section 50565-1 (50565-1)


Purpose

Upset stomach reliever and anti-diarrheal

Warnings

Reye's syndrome: Children and teenagers who have or are recovering from children 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
  • for accurate dosing, use dose cup
  • 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 clear fluids to help prevent dehydration caused by diarrhea

Other Information (Other information)
  • each Tbsp contains: sodium 5 mg, salicylate 236 mg, potassium 15 mg
  • protect from freezing
  • avoid excessive heat (over 104oF or 40oC)
  • TAMPER EVIDENT: Do not use if imprinted shrinkband is missing or broken.
Inactive Ingredients (Inactive ingredients)

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

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

Principal Display Panel

*Compare to the active ingredient in PEPTO-BISMOL® Maximum Strength

Maximum Strength Stomach Relief

Bismuth Subsalicylate / Upset Stomach Reliever & Anti-diarrheal

Soothing Relief for: Upset Stomach, Indigestion, Nausea, Heartburn & Diarrhea

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

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 15 Ml Tbsp) (Active ingredient (in each 15 mL tbsp))

Bismuth subsalicylate 525 mg

Ask A Doctor Or Pharmacist Before Use If You Are Taking Any Drug For (Ask a doctor or pharmacist before use if you are taking any drug for)

  • anticoagulation (thinning of the blood)
  • diabetes
  • gout
  • arthritis
If Pregnant Or Breast Feeding, Ask A Health Professional Before Use. Keep Out of Reach of Children. (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  immediately.


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Raw Label Data

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