Drx Choice Stomach Relief Ultra Strength Bismuth Subsalicylate 525 Mg Drug Facts

Drx Choice Stomach Relief Ultra Strength Bismuth Subsalicylate 525 Mg Drug Facts
SPL v5
SPL
SPL Set ID 75e8cd49-850f-4816-b350-ce76601ebfc0
Route
ORAL
Published
Effective Date 2021-12-21
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

Identifiers & Packaging

Pill Appearance
Color: pink
Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-12-06

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 or 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:
  • 15 mL (1 dose) every ½ hour or 30 mL (2 doses) every hour as needed for diarrhea/traveler’s diarrhea
  • 15 mL (1 dose) every ½ hour as needed 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 (over 104°F or 40°C)
Inactive Ingredients

carboxymethylcellulose sodium, D&C Red No. 22, D&C Red No. 28, flavor, microcrystalline cellulose, potassium hydroxide, potassium sorbate, purified water, salicylic acid, simethicone emulsion, sodium benzoate, sucralose, xanthan gum

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

1-866-467-2748

Do not use if imprinted shrink band is missing or broken.

Principal Display Panel

DRx Choice ®

NDC# 68163-707-12

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

Ultra strength

Pink bismuth

Bismuth Subsalicylate /

Upset Stomach Reliever/Antidiarrheal

Original Flavor

Naturally and Artificially Flavored

Relieves:

Nausea, Heartburn, Indigestion, Upset Stomach & Diarrhea

12 FL. OZ. (354 mL)

Manufactured by: Raritan Pharmaceuticals

8 Joanna Court

East Brunswick

NJ 08816

*This product is not manufactured or distributed by The Procter & Gamble Co., owner of the registered trademark Pepto-Bismol ®.

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 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

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 or 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:
  • 15 mL (1 dose) every ½ hour or 30 mL (2 doses) every hour as needed for diarrhea/traveler’s diarrhea
  • 15 mL (1 dose) every ½ hour as needed 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 (over 104°F or 40°C)
Inactive Ingredients (Inactive ingredients)

carboxymethylcellulose sodium, D&C Red No. 22, D&C Red No. 28, flavor, microcrystalline cellulose, potassium hydroxide, potassium sorbate, purified water, salicylic acid, simethicone emulsion, sodium benzoate, sucralose, xanthan gum

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

1-866-467-2748

Do not use if imprinted shrink band is missing or broken.

Principal Display Panel

DRx Choice ®

NDC# 68163-707-12

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

Ultra strength

Pink bismuth

Bismuth Subsalicylate /

Upset Stomach Reliever/Antidiarrheal

Original Flavor

Naturally and Artificially Flavored

Relieves:

Nausea, Heartburn, Indigestion, Upset Stomach & Diarrhea

12 FL. OZ. (354 mL)

Manufactured by: Raritan Pharmaceuticals

8 Joanna Court

East Brunswick

NJ 08816

*This product is not manufactured or distributed by The Procter & Gamble Co., owner of the registered trademark Pepto-Bismol ®.

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 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

All Sections (JSON)