Pepto ®

Pepto ®
SPL v10
SPL
SPL Set ID 63283ebc-cff8-07d4-e053-2a91aa0a9de0
Route
ORAL
Published
Effective Date 2023-08-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (525 mg)
Inactive Ingredients
Magnesium Stearate Mannitol Cellulose, Microcrystalline Polysorbate 80 Calcium Carbonate Povidone D&c Red No. 27 Sodium Starch Glycolate Type A Potato Silicon Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: Pepto Shape: oval Color: pink Size: 18 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2018-02-01

Description

Drug Facts

Purpose

Upset stomach reliever and antidiarrheal


Medication Information

Purpose

Upset stomach reliever and antidiarrheal

Description

Drug Facts

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 right away.

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.

Directions
  • swallow with water, do not chew
  • adults and children 12 years and over:
  • 1 caplet (1 dose) every ½ hour or 2 caplets (2 doses) every hour as needed for diarrhea
  • 1 caplet (1 dose) every ½ hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea)
  • do not exceed 8 doses (8 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
Questions?

1-800-717-3786

Allergy Alert:

Contains salicylate. Do not take if you are

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

Other Information
  • each caplet contains:calcium 54 mg
  • salicylate 199 mg
  • very low sodium
  • avoid excessive heat (over 104°F or 40°C)
Inactive Ingredients

calcium carbonate, D&C Red No. 27 aluminum lake, magnesium stearate, mannitol, microcrystalline cellulose, polysorbate 80, povidone, silicon dioxide, sodium starch glycolate

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
If Pregnant Or Breast Feeding,

ask a health professional before use.

Active Ingredient (in Each Caplet)

Bismuth subsalicylate 525 mg

Ask A Doctor Before Use If You Have

  • fever
  • mucus in the stool
Principal Display Panel 12 Caplet Carton

Pepto

Bismol® ULTRA

Bismuth Subsalicylate

Upset Stomach Reliever/

Antidiarrheal

2x CONCENTRATED FORMULA*

5 SYMPTOM RELIEF

NAUSEA

HEARTBURN

INDIGESTION

UPSET STOMACH

DIARRHEA

12 CAPLETS

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
Section 34088-5 (34088-5)

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

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.

Purpose

Upset stomach reliever and antidiarrheal

Directions
  • swallow with water, do not chew
  • adults and children 12 years and over:
  • 1 caplet (1 dose) every ½ hour or 2 caplets (2 doses) every hour as needed for diarrhea
  • 1 caplet (1 dose) every ½ hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea)
  • do not exceed 8 doses (8 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
Questions?

1-800-717-3786

Allergy Alert: (Allergy alert:)

Contains salicylate. Do not take if you are

  • allergic to salicylates (including aspirin)
  • taking other salicylate products
Reye's Syndrome: (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.

Other Information (Other information)
  • each caplet contains:calcium 54 mg
  • salicylate 199 mg
  • very low sodium
  • avoid excessive heat (over 104°F or 40°C)
Inactive Ingredients (Inactive ingredients)

calcium carbonate, D&C Red No. 27 aluminum lake, magnesium stearate, mannitol, microcrystalline cellulose, polysorbate 80, povidone, silicon dioxide, sodium starch glycolate

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

ask a health professional before use.

Active Ingredient (in Each Caplet) (Active ingredient (in each caplet))

Bismuth subsalicylate 525 mg

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

  • fever
  • mucus in the stool
Principal Display Panel 12 Caplet Carton (PRINCIPAL DISPLAY PANEL - 12 Caplet Carton)

Pepto

Bismol® ULTRA

Bismuth Subsalicylate

Upset Stomach Reliever/

Antidiarrheal

2x CONCENTRATED FORMULA*

5 SYMPTOM RELIEF

NAUSEA

HEARTBURN

INDIGESTION

UPSET STOMACH

DIARRHEA

12 CAPLETS

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)