Pepto Bismol Fast Melts Fresh Berry Flavored

Pepto Bismol Fast Melts Fresh Berry Flavored
SPL v4
SPL
SPL Set ID 039391d0-9ec1-45a3-84fa-b5f591794e41
Route
ORAL
Published
Effective Date 2024-09-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (262 mg)
Inactive Ingredients
Calcium Carbonate Carrageenan Corn Syrup Fd&c Red No. 40 Hydrogenated Coconut Oil Lecithin, Soybean Sucrose Water

Identifiers & Packaging

Pill Appearance
Imprint: C Shape: round Color: pink Size: 22 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-03-05

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.

Section 53414-9

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

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
  • fully chew before swallowing
  • adults and children 12 years and over: 

    • 2 soft chewable tablets every 1/2 hour or 4 soft chewable tablets every hour as needed for diarrhea

    • 2 soft chewable tablets every 1/2 hour to 1 hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea)

  • do not exceed 8 doses (16 soft chewable tablets) 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

Do Not Use If

you have

  • an ulcer
  • a bleeding problem
  • bloody or black stool
Other Information
  • each soft chewable tablet contains:  • calcium 55 mg  • salicylate 100 mg  • low sodium
  • Store at no greater than 25°C.  Avoid excessive heat (over 40°C).
Inactive Ingredients

calcium carbonate, carrageenan, corn syrup, FD&C Red No. 40, flavor, hydrogenated coconut oil, soy lecithin, sucrose, water

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
Active Ingredient (in Each Soft Chewable Tablet)

Bismuth subsalicylate 262 mg

Ask A Doctor Or Pharmacist Before Use If You Are

taking any drug for

  • anticoagulation (thinning the blood)
  • diabetes
  • gout
  • arthritis
Principal Display Panel 24 Soft Chewable Tablets

Pepto Bismol®

Bismuth Subsalicylate

Upset Stomach Reliever/Antidiarrheal

FAST MELTS

5 SYMPTOM RELIEF

FRESH BERRY FLAVORED

24 SOFT CHEWABLE TABLETS


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.

Section 53414-9 (53414-9)

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

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
  • fully chew before swallowing
  • adults and children 12 years and over: 

    • 2 soft chewable tablets every 1/2 hour or 4 soft chewable tablets every hour as needed for diarrhea

    • 2 soft chewable tablets every 1/2 hour to 1 hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea)

  • do not exceed 8 doses (16 soft chewable tablets) 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

Do Not Use If (Do not use if)

you have

  • an ulcer
  • a bleeding problem
  • bloody or black stool
Other Information (Other information)
  • each soft chewable tablet contains:  • calcium 55 mg  • salicylate 100 mg  • low sodium
  • Store at no greater than 25°C.  Avoid excessive heat (over 40°C).
Inactive Ingredients (Inactive ingredients)

calcium carbonate, carrageenan, corn syrup, FD&C Red No. 40, flavor, hydrogenated coconut oil, soy lecithin, sucrose, water

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
Active Ingredient (in Each Soft Chewable Tablet) (Active ingredient (in each soft chewable tablet))

Bismuth subsalicylate 262 mg

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
Principal Display Panel 24 Soft Chewable Tablets (PRINCIPAL DISPLAY PANEL - 24 SOFT CHEWABLE TABLETS)

Pepto Bismol®

Bismuth Subsalicylate

Upset Stomach Reliever/Antidiarrheal

FAST MELTS

5 SYMPTOM RELIEF

FRESH BERRY FLAVORED

24 SOFT CHEWABLE TABLETS


Advanced Ingredient Data


Raw Label Data

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