We Care pink Bismuth drug Facts

We Care pink Bismuth drug Facts
SPL v2
SPL
SPL Set ID 0d049f14-db3b-4ab7-ba97-6574016a6424
Route
ORAL
Published
Effective Date 2016-10-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (262 mg)
Inactive Ingredients
Carboxymethylcellulose Sodium D&c Red No. 30 Fd&c Red No. 40 Glycerin Magnesium Aluminum Silicate Water Saccharin Sodium Salicylic Acid Sodium Salicylate Sorbitol Sodium Benzoate

Identifiers & Packaging

Pill Appearance
Color: pink
Marketing Status
OTC MONOGRAPH FINAL Active Since 2016-10-25

Description

Bismuth subsalicylate 262 mg

Purpose

Upset stomach reliever/antidiarrheal


Medication Information

Purpose

Upset stomach reliever/antidiarrheal

Description

Bismuth subsalicylate 262 mg

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

Upset stomach reliever/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 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) 
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
Do Not Use

if you have

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

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.

Active Ingredient (in Each 15 Ml)

Bismuth subsalicylate 262 mg

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
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.


Structured Label Content

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

Upset stomach reliever/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 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) 
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
Do Not Use (Do not use)

if you have

  • an ulcer, a bleeding problem, bloody or black stool
Other Information (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 (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? (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

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
If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

Active Ingredient (in Each 15 Ml) (Active ingredient (in each 15 mL))

Bismuth subsalicylate 262 mg

Ask A Doctor Before Use If You Have (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 (Ask a doctor or pharmacist before use if you are)

taking any drug for

  • anticoagulation (thinning the blood), diabetes, gout, arthritis
Keep This and All Drugs Out of The reach of Children. (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.


Advanced Ingredient Data


Raw Label Data

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