5346 - Cardinal
d4af6694-910c-da17-e053-2995a90a8454
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
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 (1-800-222-1222) immediately.
Section 42229-5
RETAIN THIS CARTON FOR FULL LABELING INFORMATION
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.
COMPARE TO PEPTO-BISMOL active ingredient*
*This product is not manufactured or distributed by Procter & Gamble Inc., the distributor of Pepto-Bismol®.
DISTRIBUTED BY CARDINAL HEALTH
DUBLIN, OHIO 43017
www.myleader.com
1-800-200-6313
Essential to Care™ since 1979
Product of Mexico
Section 50565-1
Keep out of reach of children.
Section 50566-9
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
Section 50567-7
When using this product a temporary but harmless darkening of the stool and/or tongue may occur.
Section 50568-5
Ask a doctor or pharmacist before use if you are taking any drug for
- anticoagulation (thinning the blood)
- diabetes
- gout
- arthritis
Section 50569-3
Ask a doctor before use if you have
- fever
- mucus in the stool
Section 50570-1
Do not use if you have
- an ulcer
- a bleeding problem
- bloody or black stool
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
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 15° – 30°C (59° – 86°F)
- TAMPER EVIDENT: do not use if printed seal under cap is torn or missing
Questions Or Comments?
1-800-231-4670
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 (1-800-222-1222) immediately.
Section 42229-5 (42229-5)
RETAIN THIS CARTON FOR FULL LABELING INFORMATION
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.
COMPARE TO PEPTO-BISMOL active ingredient*
*This product is not manufactured or distributed by Procter & Gamble Inc., the distributor of Pepto-Bismol®.
DISTRIBUTED BY CARDINAL HEALTH
DUBLIN, OHIO 43017
www.myleader.com
1-800-200-6313
Essential to Care™ since 1979
Product of Mexico
Section 50565-1 (50565-1)
Keep out of reach of children.
Section 50566-9 (50566-9)
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
Section 50567-7 (50567-7)
When using this product a temporary but harmless darkening of the stool and/or tongue may occur.
Section 50568-5 (50568-5)
Ask a doctor or pharmacist before use if you are taking any drug for
- anticoagulation (thinning the blood)
- diabetes
- gout
- arthritis
Section 50569-3 (50569-3)
Ask a doctor before use if you have
- fever
- mucus in the stool
Section 50570-1 (50570-1)
Do not use if you have
- an ulcer
- a bleeding problem
- bloody or black stool
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)
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 (Other information)
- each caplet contains: salicylate 102 mg
- Store in a dry place at 15° – 30°C (59° – 86°F)
- TAMPER EVIDENT: do not use if printed seal under cap is torn or missing
Questions Or Comments? (Questions or comments?)
1-800-231-4670
Advanced Ingredient Data
Raw Label Data
All Sections (JSON)
Additional Information
Back to search View SPL set listing Open on DailyMed ↗
Source: dailymed · Ingested: 2026-02-15T12:05:32.359811 · Updated: 2026-03-14T23:07:28.673990