Quality Choice Pink Bismuth Subsalicylate 262 Mg

Quality Choice Pink Bismuth Subsalicylate 262 Mg
SPL v6
SPL
SPL Set ID f69f5164-f227-4527-ac1c-cda213b96b25
Route
ORAL
Published
Effective Date 2019-04-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (262 mg)
Inactive Ingredients
Calcium Carbonate Crospovidone (120 .mu.m) D&c Red No. 27 Magnesium Stearate Maltodextrin Microcrystalline Cellulose Sodium Lauryl Sulfate

Identifiers & Packaging

Pill Appearance
Imprint: V Shape: oval Color: white Size: 17 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-04-15

Description

Active ingredient (in each caplet) Bismuth subsalicylate 262 mg


Medication Information

Warnings and Precautions

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.
Description

Active ingredient (in each caplet) 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

Section 34088-5

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

Section 50565-1

Keep out of reach of children.

Section 51945-4

NDC# 63868-171-40

Compare to Pepto-Bismol® Regular Strength the active ingredient*

Pink Bismuth

Stomach Relief

Bismuth Subsalicylate 262mg

Upset stomach Indigestion, Nausea, Heartburn, Diarrhea

Package Contains One Bottle

40 Caplets

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®.

Section 53414-9

If pregnant or breast-feeding,ask a health professional before use.

Section 55105-1

Purpose

Upset stomach reliever and anti-diarrheal

Directions
  • swallow with water, do not chew
  • adults and children 12 years and older:2 caplets every 1/2 to 1 hour as needed
  • do not exceed 8 doses (16 caplets) 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
Drug Facts

Active ingredient (in each caplet)

Bismuth subsalicylate 262 mg

Other Information
  • each caplet contains: calcium 27 mg, sodium 3 mg
  • salicylate 99 mg
  • low sodium
  • sugar free
  • store at room temperature.
Inactive Ingredients

calcium carbonate, crospovidone, D&C red #27 aluminum lake, magnesium stearate, maltodextrin, microcrystalline cellulose, sodium lauryl sulfate.

Do Not Use If You Have
  • an ulcer
  • a bleeding problem
  • bloody or black stool
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
Ask A Doctor Before Use If You Have
  • fever
  • mucus in the stool
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 ■ fullness

Warnings and Precautions (34071-1)

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.
Section 34088-5 (34088-5)

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

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 51945-4 (51945-4)

NDC# 63868-171-40

Compare to Pepto-Bismol® Regular Strength the active ingredient*

Pink Bismuth

Stomach Relief

Bismuth Subsalicylate 262mg

Upset stomach Indigestion, Nausea, Heartburn, Diarrhea

Package Contains One Bottle

40 Caplets

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®.

Section 53414-9 (53414-9)

If pregnant or breast-feeding,ask a health professional before use.

Section 55105-1 (55105-1)

Purpose

Upset stomach reliever and anti-diarrheal

Directions
  • swallow with water, do not chew
  • adults and children 12 years and older:2 caplets every 1/2 to 1 hour as needed
  • do not exceed 8 doses (16 caplets) 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
Drug Facts

Active ingredient (in each caplet)

Bismuth subsalicylate 262 mg

Other Information
  • each caplet contains: calcium 27 mg, sodium 3 mg
  • salicylate 99 mg
  • low sodium
  • sugar free
  • store at room temperature.
Inactive Ingredients

calcium carbonate, crospovidone, D&C red #27 aluminum lake, magnesium stearate, maltodextrin, microcrystalline cellulose, sodium lauryl sulfate.

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

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
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)

taking any drug for

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

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)