Qc Pink Bismuth Subsalicylate 262mg 30 Chewable Tablets

Qc Pink Bismuth Subsalicylate 262mg 30 Chewable Tablets
SPL v1
SPL
SPL Set ID a6ce7a58-bdbf-472d-af2f-014b07f12266
Route
ORAL
Published
Effective Date 2020-03-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (262 mg)
Inactive Ingredients
Magnesium Stearate Microcrystalline Cellulose D&c Red No. 27 Sorbitol Sucralose

Identifiers & Packaging

Pill Appearance
Imprint: RP124 Shape: round Color: pink Size: 17 mm Score: 1
Marketing Status
OTC MONOGRAPH FINAL Active Since 2020-02-24

Description

Bismuth subsalicylate 262 mg

Purpose

Upset stomach reliever and antidiarrheal


Medication Information

Purpose

Upset stomach reliever and antidiarrheal

Description

Bismuth subsalicylate 262 mg

Uses

relieves:

  • travelers’ diarrhea
  • diarrhea
  • upset stomach due to overindulgence in food and drink, including:
  • heartburn
  • indigestion
  • nausea
  • gas
  • belching
  • fullness
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
Directions
  • chew completely or dissolve tablets in mouth.
  • adults and children 12 years and older: 2 tablets (1 dose) every ½ hour to 1 hour as needed
  • do not exceed 8 doses (16 tablets) in 24 hours
  • use until diarrhea stops but not more than 2 days
  • children under 12 years: ask a doctor
  • drink plenty clear fluids to help prevent dehydration caused by diarrhea.
Questions?

248-449-9300

Other Information
  • each tablet contains: salicylate 102 mg
  • store at room temperature.
  • avoid excessive heat
  • keep this carton for future reference on full labeling

TAMPER EVIDENT: Do not use if printed inner wrap is broken or missing.

Principal Display

QUALITY CHOICE®

NDC# 63868-421-30

Compare to the active ingredient in PEPTO-BISMOL®

Pink Bismuth

Stomach Relief

Bismuth Subsalicylate 262 mg

Soothing Relief for: Upset stomach, Indigestion, Nausea, Heartburn, Diarrhea

Original Flavor

30 Chewable Tablets

QC SATISFACTION GUARANTEED

DISTRIBUTED BY:

C.D.M.A., Inc.

43157 W. Nine Mile

Novi, MI 48376-0995

www.qualitychoice.com

Questions: 248-449-9300

*This product is not manufactured or distributed by PROCTER & GAMBLE INC., the distributor of Pepto-Bismol®

Inactive Ingredients

flavor, magnesium stearate, microcrystalline cellulose, red# 27 aluminum lake, sorbitol, sucralose.

Do Not Use If You Have
  • an ulcer
  • a bleeding problem
  • bloody or black stool
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
Keep Out of Reach of Children

In case of overdose, get medical help or contact a Poison Control Center immediately at 1-800-222-1222

Active Ingredient (in Each Tablet)

Bismuth subsalicylate 262 mg

Ask A Doctor Before Use If You Have
  • fever
  • mucus in the stool
Ask A Doctor Or Pharmacist Before Use If You Are
  • anticoagulation (thinning of 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
  • fullness
Purpose

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 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
  • chew completely or dissolve tablets in mouth.
  • adults and children 12 years and older: 2 tablets (1 dose) every ½ hour to 1 hour as needed
  • do not exceed 8 doses (16 tablets) in 24 hours
  • use until diarrhea stops but not more than 2 days
  • children under 12 years: ask a doctor
  • drink plenty clear fluids to help prevent dehydration caused by diarrhea.
Questions?

248-449-9300

Other Information (Other information)
  • each tablet contains: salicylate 102 mg
  • store at room temperature.
  • avoid excessive heat
  • keep this carton for future reference on full labeling

TAMPER EVIDENT: Do not use if printed inner wrap is broken or missing.

Principal Display

QUALITY CHOICE®

NDC# 63868-421-30

Compare to the active ingredient in PEPTO-BISMOL®

Pink Bismuth

Stomach Relief

Bismuth Subsalicylate 262 mg

Soothing Relief for: Upset stomach, Indigestion, Nausea, Heartburn, Diarrhea

Original Flavor

30 Chewable Tablets

QC SATISFACTION GUARANTEED

DISTRIBUTED BY:

C.D.M.A., Inc.

43157 W. Nine Mile

Novi, MI 48376-0995

www.qualitychoice.com

Questions: 248-449-9300

*This product is not manufactured or distributed by PROCTER & GAMBLE INC., the distributor of Pepto-Bismol®

Inactive Ingredients (Inactive ingredients)

flavor, magnesium stearate, microcrystalline cellulose, red# 27 aluminum lake, sorbitol, sucralose.

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

In case of overdose, get medical help or contact a Poison Control Center immediately at 1-800-222-1222

Active Ingredient (in Each Tablet) (Active ingredient (in each tablet))

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
Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)
  • anticoagulation (thinning of the blood)
  • diabetes
  • gout
  • arthritis

Advanced Ingredient Data


Raw Label Data

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