Drug Facts

Drug Facts
SPL v6
SPL
SPL Set ID 0316f469-e9fa-47c3-bb20-bd4588b40bcc
Route
ORAL
Published
Effective Date 2023-11-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Bismuth Cation (262 mg)
Inactive Ingredients
Carboxymethylcellulose Sodium, Unspecified Fd&c Red No. 40 Microcrystalline Cellulose Sodium Salicylate Sorbic Acid Sucrose Water Xanthan Gum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-10-01 Until 2025-08-01

Description

Active ingredient (per 15 mL) Purposes Bismuth subsalicylate 262 mg Anti-diarrheal Upset stomach reliever


Medication Information

Indications and Usage

Uses relieves:

  • traveler’s diarrhea

  • diarrhea
  • upset stomach due to overindulgence in food and drink, including:
    • heartburn
    • indigestion

    • nausea

    • gas

    • belching

    • fullness



Description

Active ingredient (per 15 mL) Purposes Bismuth subsalicylate 262 mg Anti-diarrheal Upset stomach reliever

Section 42229-5

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.

Section 50565-1

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Section 50567-7

When using this product a temporary, but harmless, darkening of the stool and/or tongue may occur

Section 50569-3

Ask a doctor or pharmacist before use if you are taking any drug for

  • diabetes

  • gout

  • arthritis

  • anticoagulation (thinning the blood)
Section 53414-9

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

Section 55105-1
Active ingredient (per 15 mL) Purposes
Bismuth subsalicylate 262 mg Anti-diarrheal

Upset stomach reliever
Directions
  • shake well immediately before each use
  • only use pre-measured dose cup

  • adults and children 12 years of age and older:
    • 1 dose (30 mL) every 1/2 hour to 1 hour as needed.
    • do not exceed 8 doses (240 mL) 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
Other Information
  •  each 15 mL dose cup contains: sodium 6 mg and salicylate 135mg
  •  store at room temperature 20º-25º C (68º-77º F)
Inactive Ingredients

carboxymethylcellulose sodium, FD&C Red No. 40, flavor microcrystalline cellulose, purified water, sodium salicylate, sorbic acid, sucrose, xanthan gum

Do Not Take If You Are
  • allergic to salicylates (including aspirin)

  • taking other salicylate products
Do Not Use If You Have
  • an ulcer

  • a bleeding problem

  • bloody or black stool
Principal Display Panel

NEW IMPROVED TASTE!



Kaopectate
®

Bismuth Subsalicylate 262 MG

• Anti-Diarrheal • Upset Stomach Reliever



Diarrhea & 

Upset Stomach



✓ Begins controlling symptoms from the first dose

✓ Quickly relieves urgency, gas, and cramping

✓ Effective on diarrhea from bacteria,

    viruses, and other causes



11 fl oz (325mL)



Peppermint Flavor



681PPT11KA0 F

Kaopectate Peppermint 11 oz



Do not use if inner seal is broken

or missing




Kramer Laboratories

Bridgewater, NJ 08807

1-800-824-4894



Lot:



Exp:



PEEL CORNER TO READ COMPLETE

DRUG FACTS AND INFORMATION



681PPT11KA0LB





   

  

Stop Use and Ask A Doctor If
  • symptoms get worse

  • ringing in the ears or loss of hearing occurs

  • diarrhea lasts more than 2 days
Ask A Doctor Before Use If You Have
  • a sodium-restricted diet
  • fever

  • mucus in the stool

Structured Label Content

Indications and Usage (34067-9)

Uses relieves:

  • traveler’s diarrhea

  • diarrhea
  • upset stomach due to overindulgence in food and drink, including:
    • heartburn
    • indigestion

    • nausea

    • gas

    • belching

    • fullness



Section 42229-5 (42229-5)

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.

Section 50565-1 (50565-1)

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Section 50567-7 (50567-7)

When using this product a temporary, but harmless, darkening of the stool and/or tongue may occur

Section 50569-3 (50569-3)

Ask a doctor or pharmacist before use if you are taking any drug for

  • diabetes

  • gout

  • arthritis

  • anticoagulation (thinning the blood)
Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)
Active ingredient (per 15 mL) Purposes
Bismuth subsalicylate 262 mg Anti-diarrheal

Upset stomach reliever
Directions
  • shake well immediately before each use
  • only use pre-measured dose cup

  • adults and children 12 years of age and older:
    • 1 dose (30 mL) every 1/2 hour to 1 hour as needed.
    • do not exceed 8 doses (240 mL) 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
Other Information
  •  each 15 mL dose cup contains: sodium 6 mg and salicylate 135mg
  •  store at room temperature 20º-25º C (68º-77º F)
Inactive Ingredients

carboxymethylcellulose sodium, FD&C Red No. 40, flavor microcrystalline cellulose, purified water, sodium salicylate, sorbic acid, sucrose, xanthan gum

Do Not Take If You Are (Do not take if you are)
  • allergic to salicylates (including aspirin)

  • taking other salicylate products
Do Not Use If You Have (Do not use if you have)
  • an ulcer

  • a bleeding problem

  • bloody or black stool
Principal Display Panel

NEW IMPROVED TASTE!



Kaopectate
®

Bismuth Subsalicylate 262 MG

• Anti-Diarrheal • Upset Stomach Reliever



Diarrhea & 

Upset Stomach



✓ Begins controlling symptoms from the first dose

✓ Quickly relieves urgency, gas, and cramping

✓ Effective on diarrhea from bacteria,

    viruses, and other causes



11 fl oz (325mL)



Peppermint Flavor



681PPT11KA0 F

Kaopectate Peppermint 11 oz



Do not use if inner seal is broken

or missing




Kramer Laboratories

Bridgewater, NJ 08807

1-800-824-4894



Lot:



Exp:



PEEL CORNER TO READ COMPLETE

DRUG FACTS AND INFORMATION



681PPT11KA0LB





   

  

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • symptoms get worse

  • 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)
  • a sodium-restricted diet
  • fever

  • mucus in the stool

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)