rite aid ultra strength pink bismuth subsalicylate drug facts

rite aid ultra strength pink bismuth subsalicylate drug facts
SPL v3
SPL
SPL Set ID 3ffb2bb9-6d6a-4c38-ac59-0ac0d754de28
Route
oral
Published
Effective Date 2023-01-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
bismuth cation (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

Identifiers & Packaging

Pill Appearance
Color: pink
Marketing Status
otc monograph drug active Since 2023-01-02

Purpose

Upset stomach reliever and antidiarrheal

Description

Bismuth subsalicylate 525 mg


Medication Information

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
Uses

relieves

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

Upset stomach reliever and antidiarrheal

Directions
  • shake well before use
  • Only use dose cup provided
  • adults and children 12 years and over: 15 mL (1 dose) every1/2 hour or 30 mL (2 doses) every hours as needed for diarrhea/traveler’s diarrhea
  • 15 mL (1dose) every ½ hour as needed for overindulgence (Upset stomach, heartburn, indigestion, nausea)
  • do not exceed 8 doses (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 15 mL contains: sodium 10 mg
  • salicylate 230 mg
  • low sodium
  • sugar free
  • store at room temperature.
  • protect from freezing
  • avoid excessive heat (more than 104°F or 40°C).
Inactive Ingredients

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

Description

Bismuth subsalicylate 525 mg

Principal Display Panel

*Compare to the active ingredient in Pepto-Bismol® Ultra Strength *

Ultra-Strength

Pink Bismuth

Bismuth Subsalicylate

Upset Stomach Reliever/Antidiarrheal

Original flavor

Relieves:

  • Nausea
  • Heartburn
  • Indigestion
  • Upset Stomach
  • Diarrhea

12FL. OZ. (354 mL)

Distributed By:

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

Package Label 354 mL

Purposes

Upset stomach reliever and antidiarrheal

Do Not Use

if you have

  • an ulcer
  • a bleeding problem
  • bloody or black stool
Package Label 236 Ml
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
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 at (1-800-222-1222).

Ask A Doctor Before Use If You Have
  • fever
  • mucus in the stool
Active Ingredient (in Each 15 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

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
Uses

relieves

  • travelers’ diarrhea
  • diarrhea
  • upset stomach due to overindulgence in food and drink, including:
  • heartburn
  • indigestion
  • nausea
  • gas
  • belching
  • fullness
Directions
  • shake well before use
  • Only use dose cup provided
  • adults and children 12 years and over: 15 mL (1 dose) every1/2 hour or 30 mL (2 doses) every hours as needed for diarrhea/traveler’s diarrhea
  • 15 mL (1dose) every ½ hour as needed for overindulgence (Upset stomach, heartburn, indigestion, nausea)
  • do not exceed 8 doses (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 15 mL contains: sodium 10 mg
  • salicylate 230 mg
  • low sodium
  • sugar free
  • store at room temperature.
  • protect from freezing
  • avoid excessive heat (more than 104°F or 40°C).
Inactive Ingredients (Inactive ingredients)

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

Principal Display Panel

*Compare to the active ingredient in Pepto-Bismol® Ultra Strength *

Ultra-Strength

Pink Bismuth

Bismuth Subsalicylate

Upset Stomach Reliever/Antidiarrheal

Original flavor

Relieves:

  • Nausea
  • Heartburn
  • Indigestion
  • Upset Stomach
  • Diarrhea

12FL. OZ. (354 mL)

Distributed By:

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

Package Label 354 mL

Purposes

Upset stomach reliever and antidiarrheal

Do Not Use (Do not use)

if you have

  • an ulcer
  • a bleeding problem
  • bloody or black stool
Package Label 236 Ml (Package Label 236 mL)
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
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 at (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 15 Ml Dose) (Active ingredient (in each 15 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

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