Digestive Relief Bismuth Subsalicylate 262 Mg

Digestive Relief Bismuth Subsalicylate 262 Mg
SPL v6
SPL
SPL Set ID 5538d56a-b258-4260-b51b-f5131bd76885
Route
ORAL
Published
Effective Date 2020-10-08
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: RP125 Shape: oval Color: pink Size: 16 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-10-05

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# 21130-125-40

Compare to the active ingredient Pepto-Bismol®*

Digestive Relief

Bismuth Subsalicylate 262 mg

Upset Stomach Reliever/ Antidiarrheal

5 Symptoms Digestive Relief

  • Heartburn
  • Indigestion
  • Nausea
  • Upset Stomach
  • Diarrhea

40 CAPLETS

TAMPER EVIDENT: DO NOT USE IF PRINTED INNER SEAL UNDER CAP IS BROKEN OR MISSING

Distributed by:

*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 No. 27, 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# 21130-125-40

Compare to the active ingredient Pepto-Bismol®*

Digestive Relief

Bismuth Subsalicylate 262 mg

Upset Stomach Reliever/ Antidiarrheal

5 Symptoms Digestive Relief

  • Heartburn
  • Indigestion
  • Nausea
  • Upset Stomach
  • Diarrhea

40 CAPLETS

TAMPER EVIDENT: DO NOT USE IF PRINTED INNER SEAL UNDER CAP IS BROKEN OR MISSING

Distributed by:

*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 No. 27, 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)