5346 - Cardinal

5346 - Cardinal
SPL v3
SPL
SPL Set ID d4af6694-910c-da17-e053-2995a90a8454
Route
ORAL
Published
Effective Date 2024-01-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Pill Appearance
Imprint: V Shape: oval Color: white Size: 17 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-01-03

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

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