5346-cvs

5346-cvs
SPL v5
SPL
SPL Set ID 6dd7c01c-5726-e6db-e053-2a91aa0a968d
Route
ORAL
Published
Effective Date 2026-02-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (262 mg)
Inactive Ingredients
Magnesium Stearate Microcrystalline Cellulose Silicon Dioxide Triacetin Light Mineral Oil Croscarmellose Crospovidone Hypromelloses Povidone K30 Sodium Lauryl Sulfate Stearic Acid Talc Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: V Shape: oval Color: white Size: 17 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2018-07-06
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.

Section 42229-5

RETAIN THIS CARTON FOR FULL LABELING INFORMATION

*CVS™ is not affiliated with the owner of the registered trademark Pepto-Bismol®.

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

© 2026 CVS/pharmacy

CVS.com® 1-800-SHOP CVS

V-30287

WARNING: THIS PRODUCT CAN EXPOSE YOU TO CHEMICALS INCLUDING LEAD, WHICH IS KNOWN TO THE STATE OF CALIFORNIA TO CAUSE CANCER AND BIRTH DEFECTS OR OTHER REPRODUCTIVE HARM. FOR MORE INFORMATION GO TO WWW.P65WARNINGS.CA.GOV.

Section 50565-1

Keep out of reach of children.

Section 51727-6

croscarmellose sodium, crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, mineral oil, povidone, silica, sodium lauryl sulfate, stearic acid, talc, titanium dioxide, triacetin.

Section 51945-4

CVS™

NDC 69842-346-28

STOMACH RELIEF

Bismuth Subsalicylate, 262 mg

Upset Stomach Reliever/Antidiarrheal

Compare to Pepto-Bismol® active ingredient*

Relieves 5 symptoms:

Heartburn, Indigestion, Upset stomach, Nausea, Diarrhea

40 CAPLETS

Section 53414-9

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

Section 55105-1

Purpose

Upset stomach reliever and antidiarrheal

Directions
  • swallow caplets with water, do not chew
  • adults and children 12 years and over: 2 caplets (1 dose) every 1/2 hour or 4 caplets (2 doses) every hour as needed for diarrhea
  • 2 caplets (1 dose) every 1/2 hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea)
  • 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: salicylate 102 mg
  • store in a dry place at 15º - 30º C (59º - 86º F)
  • TAMPER EVIDENT: do not use if printed seal under cap is torn or missing

Do Not Use If You Have
  • an ulcer
  • a bleeding problem
  • bloody or black stool
Questions Or Comments?

1-800-231-4670

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.

Section 42229-5 (42229-5)

RETAIN THIS CARTON FOR FULL LABELING INFORMATION

*CVS™ is not affiliated with the owner of the registered trademark Pepto-Bismol®.

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

© 2026 CVS/pharmacy

CVS.com® 1-800-SHOP CVS

V-30287

WARNING: THIS PRODUCT CAN EXPOSE YOU TO CHEMICALS INCLUDING LEAD, WHICH IS KNOWN TO THE STATE OF CALIFORNIA TO CAUSE CANCER AND BIRTH DEFECTS OR OTHER REPRODUCTIVE HARM. FOR MORE INFORMATION GO TO WWW.P65WARNINGS.CA.GOV.

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 51727-6 (51727-6)

croscarmellose sodium, crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, mineral oil, povidone, silica, sodium lauryl sulfate, stearic acid, talc, titanium dioxide, triacetin.

Section 51945-4 (51945-4)

CVS™

NDC 69842-346-28

STOMACH RELIEF

Bismuth Subsalicylate, 262 mg

Upset Stomach Reliever/Antidiarrheal

Compare to Pepto-Bismol® active ingredient*

Relieves 5 symptoms:

Heartburn, Indigestion, Upset stomach, Nausea, Diarrhea

40 CAPLETS

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 antidiarrheal

Directions
  • swallow caplets with water, do not chew
  • adults and children 12 years and over: 2 caplets (1 dose) every 1/2 hour or 4 caplets (2 doses) every hour as needed for diarrhea
  • 2 caplets (1 dose) every 1/2 hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea)
  • 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: salicylate 102 mg
  • store in a dry place at 15º - 30º C (59º - 86º F)
  • TAMPER EVIDENT: do not use if printed seal under cap is torn or missing

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?)

1-800-231-4670

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)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:43.576844 · Updated: 2026-03-14T23:13:53.589370