Pepto Relief Bismuth Subsalicylate 262 Mg

Pepto Relief Bismuth Subsalicylate 262 Mg
SPL v2
SPL
SPL Set ID a6f383b4-47f9-4837-93e2-2ca114fb20b9
Route
ORAL
Published
Effective Date 2017-10-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Bismuth Cation (262 mg)
Inactive Ingredients
Calcium Carbonate D&c Red No. 27 Dextrose Cherry Magnesium Stearate Maltodextrin Silicon Dioxide Sorbitol

Identifiers & Packaging

Pill Appearance
Imprint: AP;045 Shape: round Color: pink Size: 16 mm Score: 1
Marketing Status
OTC MONOGRAPH FINAL Active Since 2015-06-01

Description

.

Purpose

Anti-diarrheal/Upset stomach reliever


Medication Information

Purpose

Anti-diarrheal/Upset stomach reliever

Description

.

Uses
  • Controls diarrhea
  • Relieves upset stomach due to overindulgence in food or drink
Section 50565-1

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

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: Do not take if you are

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

    Do not use

  • If you have bloody or black stool
  • If you have an ulcer or bleeding problem

    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

    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.

Directions
  • drink plenty of clear fluids to help prevent dehydration caused by diarrhea
  • repeat dosage every 1/2 to 1 hour as needed
  • do not take more than 8 doses in 24 hours
  • use until diarrhea stops but not more than 2 days
  • adults and children 12 years and over: 2 tablets
  • children under 12 years: ask a doctor
Drug Facts

.

Package Label

NDC:  54738-102-30

– 30 TABLETS

NDC: 54738-102-48- 48  TABLETS

Active Ingredient

(in each tablet)

Bismuth subsalicylate 262 mg

Other Information
  • Each tablet contains: calcium 77 mg, salicylate 102 mg
  • store at 15°-30°C (59°-86°F)
  • protect from moisture
Inactive Ingredient

calcium carbonate, D&C red # 27 (Al-lake), dextrose, flavor (cherry), magnesium stearate, maltodextrin, silicon dioxide, sorbitol

Questions Or Comments

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Call 804-270-4498, 8.30 am – 4.30 pm EST Monday - Friday


Structured Label Content

Uses
  • Controls diarrhea
  • Relieves upset stomach due to overindulgence in food or drink
Section 50565-1 (50565-1)

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Purpose

Anti-diarrheal/Upset stomach reliever

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: Do not take if you are

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

    Do not use

  • If you have bloody or black stool
  • If you have an ulcer or bleeding problem

    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

    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.

Directions
  • drink plenty of clear fluids to help prevent dehydration caused by diarrhea
  • repeat dosage every 1/2 to 1 hour as needed
  • do not take more than 8 doses in 24 hours
  • use until diarrhea stops but not more than 2 days
  • adults and children 12 years and over: 2 tablets
  • children under 12 years: ask a doctor
Drug Facts

.

Package Label

NDC:  54738-102-30

– 30 TABLETS

NDC: 54738-102-48- 48  TABLETS

Active Ingredient

(in each tablet)

Bismuth subsalicylate 262 mg

Other Information
  • Each tablet contains: calcium 77 mg, salicylate 102 mg
  • store at 15°-30°C (59°-86°F)
  • protect from moisture
Inactive Ingredient (INACTIVE INGREDIENT)

calcium carbonate, D&C red # 27 (Al-lake), dextrose, flavor (cherry), magnesium stearate, maltodextrin, silicon dioxide, sorbitol

Questions Or Comments (Questions or Comments)

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Call 804-270-4498, 8.30 am – 4.30 pm EST Monday - Friday


Advanced Ingredient Data


Raw Label Data

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