Cvs Health ™

Cvs Health ™
SPL v8
SPL
SPL Set ID c0bb2b6e-8187-495e-8eac-2324fae86cf5
Route
ORAL
Published
Effective Date 2025-12-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (262 mg)
Inactive Ingredients
D&c Red No. 27 Magnesium Stearate Maltodextrin Microcrystalline Cellulose Sorbitol Sucralose

Identifiers & Packaging

Pill Appearance
Imprint: RP124 Shape: round Color: pink Size: 17 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-03-19

Description

Bismuth subsalicylate 262 mg

Purpose

Upset stomach reliever and anti-diarrheal


Medication Information

Purpose

Upset stomach reliever and anti-diarrheal

Description

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
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
  • chew completely or dissolve tablets in mouth.
  • adults and children 12 years and older:2 tablets every 1/2 to 1 hour as needed
  • do not exceed 8 doses (16 tablets) in 24 hours
  • use until diarrhea stops but not more than 2 days
  • children under 12 years:ask a doctor
  • drink plenty clear fluids to help prevent dehydration caused by diarrhea.
Questions?

1-866-467-2748

Other Information
  • each tablet contains: salicylate 102 mg
  • store at room temperature
  • avoid excessive heat
  • keep this carton for future reference on full labeling

TAMPER EVIDENT: DO NOT USE IF THE ADHESIVE LABELS AROUND THE BOTTLE CAP IS TORN, BROKEN OR MISSING.

Principal Display

CVS Health

NDC# 69842-221-12

Compare To the active ingredient in Pepto-Bismol ®Tablets*

Cherry Flavor

Original TWIN PACK

Stomach relief

BISMUTH SUBSALICYLATE 262 mg

Upset stomach reliever/Antidiarrheal

Soothing relief for 5 symptoms:

  • Heartburn
  • Indigestion Nausea
  • Upset stomach
  • Diarrhea

2-12 COUNT BOTTLES

24 CHEWABLE TABLETS TOTAL

Cherry Flavor

Distributed by:

CVS Pharmacy, Inc.

One CVS Drive

Woonsocket, RI 02895

© 2016 CVS/pharmacy

CVS.com 1-800-SHOP CVS

V-16415

*This product is not manufactured or distributed by The Procter & Gamble Co., the distributor of Pepto-Bismol ®.

Package Label for 24 Chewable tablets

Inactive Ingredients

D&C Red No. 27 lake, flavor, magnesium stearate, maltodextrin, microcrystalline cellulose, sorbitol, sucralose.

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
Keep Out of Reach of Children

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

Active Ingredient (in Each Tablet)

Bismuth subsalicylate 262 mg

Ask A Doctor Before Use If You Have
  • fever
  • mucus in the stool
Package Label for 30 Chewable Tablets
Ask A Doctor Or Pharmacist Before Use If You Are
  • anticoagulation (thinning of 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
Purpose

Upset stomach reliever and anti-diarrheal

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
  • chew completely or dissolve tablets in mouth.
  • adults and children 12 years and older:2 tablets every 1/2 to 1 hour as needed
  • do not exceed 8 doses (16 tablets) in 24 hours
  • use until diarrhea stops but not more than 2 days
  • children under 12 years:ask a doctor
  • drink plenty clear fluids to help prevent dehydration caused by diarrhea.
Questions?

1-866-467-2748

Other Information (Other information)
  • each tablet contains: salicylate 102 mg
  • store at room temperature
  • avoid excessive heat
  • keep this carton for future reference on full labeling

TAMPER EVIDENT: DO NOT USE IF THE ADHESIVE LABELS AROUND THE BOTTLE CAP IS TORN, BROKEN OR MISSING.

Principal Display

CVS Health

NDC# 69842-221-12

Compare To the active ingredient in Pepto-Bismol ®Tablets*

Cherry Flavor

Original TWIN PACK

Stomach relief

BISMUTH SUBSALICYLATE 262 mg

Upset stomach reliever/Antidiarrheal

Soothing relief for 5 symptoms:

  • Heartburn
  • Indigestion Nausea
  • Upset stomach
  • Diarrhea

2-12 COUNT BOTTLES

24 CHEWABLE TABLETS TOTAL

Cherry Flavor

Distributed by:

CVS Pharmacy, Inc.

One CVS Drive

Woonsocket, RI 02895

© 2016 CVS/pharmacy

CVS.com 1-800-SHOP CVS

V-16415

*This product is not manufactured or distributed by The Procter & Gamble Co., the distributor of Pepto-Bismol ®.

Package Label for 24 Chewable tablets

Inactive Ingredients (Inactive ingredients)

D&C Red No. 27 lake, flavor, magnesium stearate, maltodextrin, microcrystalline cellulose, sorbitol, sucralose.

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
Keep Out of Reach of Children

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

Active Ingredient (in Each Tablet) (Active ingredient (in each tablet))

Bismuth subsalicylate 262 mg

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • fever
  • mucus in the stool
Package Label for 30 Chewable Tablets (Package Label for 30 Chewable tablets)
Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)
  • anticoagulation (thinning of the blood)
  • diabetes
  • gout
  • arthritis

Advanced Ingredient Data


Raw Label Data

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