Pink Bismuth
FDA Label NDC 70005-047

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by We Care Distributor Inc. for the product Pink Bismuth (NDC 70005-047). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient (in each 15 ml), purposes, uses, warnings, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient (In Each 15 Ml)

Bismuth subsalicylate 262 mg

Purposes

Upset stomach reliever/antidiarrheal

Uses

  • relieves upset stomach, heartburn, indigestion, nausea, diarrhea

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 vomitting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrom, a rare but serious illness.

Allergy alert:Contains salicylates. Do not take if you are

  • taking other salicylate products
  • allergic to salicylates (including aspirin) 

Do Not Use

if you have

  • an ulcer, a bleeding problem, bloody or black stool

Ask A Doctor Before Use If You Have

  • fever, mucus in the stool, a sodium-restricted diet, a magnesium restricted diet

Ask A Doctor Or Pharmacist Before Use If You Are

taking any drug for

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

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

If Pregnant Or Breast-Feeding,

ask a health professional before use.

Keep This And All Drugs Out Of The Reach Of Children.

In case of accidental overdose, seek professional assistance or contact a Poison Control Center right away.

Directions

  • Shake well before use
  • Use pre-measured cup for accurate dosing. mL = mililiter
  • Adults and children 12 years and over: 1 dose (30 mL) every 1/2 to 1 hour as needed
  • Do not take more than 4 doses 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 24 mg, Sugar free, Magnesium 32 mg
  • Salicylate 159 mg
  • Keep tightly closed
  • Avoid excessive heat (over 104°F or 40°C)
  • protect from freezing
  • store at room temperature
  • TEMPER EVIDENT: DO NOT USE THIS PRODUCT IF PRINTED INNER CAP SEAL IS BROKEN OR MISSING

Inactive Ingredients

carboxymethylcellulose sodium, D&C red #3, FD&C red #40, flavor, glycerin, magnesium aluminum silicate, saccharin sodium, salicylic acid, sodium benzoate, sodium salicylate, sorbitol, water

Questions Or Comments?

1-888-705-WECARE (Mon-Fri 9am-5pm EST) or www.wecaredistributor.com

Principal Display Panel

Compare to Original Pepto-Bismol® active ingredient

ORIGINAL STRENGTH

Stomach Relief

Upset Stomach Reliever/Antidiarrheal

Bismuth Subsalicylate 262 mg

Protective Coating Action

Soothing Relief for 5 Symptoms:

Heartburn

Indigestion

Upset Stomach

Nausea

Diarrhea

* Please review the disclaimer below.