Drug Facts

Drug Facts
SPL v5
SPL
SPL Set ID 2f6766a1-d775-40bf-a039-975ab47fcceb
Route
ORAL
Published
Effective Date 2023-12-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Bismuth Cation (262 mg)
Inactive Ingredients
Calcium Carbonate Sucrose Corn Syrup Fd&c Red No. 40 Glycerin Hydrogenated Coconut Oil Lecithin, Soybean Water

Identifiers & Packaging

Pill Appearance
Imprint: K Shape: rectangle Color: pink Size: 23 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-02-01

Description

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

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 50568-5

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

  • anticoagulation (thinning the blood)

  • diabetes

  • gout

  • arthritis
Section 53414-9

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

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

Upset stomach reliever
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. 

Directions
  • adults and children 12 years of age and older: 2 chews (1 dose)
  • repeat dose every 1/2 hour to 1 hour as needed

  • do not exceed 8 doses 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 soft chew contains: total salicylates 99 mg

  • do not use if carton was opened or if printed foil inner seal under bottle cap is torn or missing

  • store at room temperature 20º-25º C (68º-77º F)
Inactive Ingredients

calcium carbonate, confectioner’s sugar, corn syrup, corn syrup solids, FD&C red #40 aluminum lake, glycerin, hydrogenated coconut oil, natural masking flavor, soy lecithin, strawberry flavor, sucrose, water

  

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

GREAT TASTE!



FAST & EFFECTIVE RELIEF



Kaopectate
®

Bismuth Subsalicylate • Anti-Diarrheal • Upset Stomach Reliever



Soft Chews



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



24 Soft Chews

Individually wrapped



Strawberry Flavor

FAST & EFFECTIVE RELIEF



Do not take maximum dose for more than 2 days per week.



Kramer Laboratories, Inc.

Bridgewater, NJ 08807

1-800-824-4894



502851

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
  • 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 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 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 53414-9 (53414-9)

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

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

Upset stomach reliever
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. 

Directions
  • adults and children 12 years of age and older: 2 chews (1 dose)
  • repeat dose every 1/2 hour to 1 hour as needed

  • do not exceed 8 doses 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 (Other information)
  • each soft chew contains: total salicylates 99 mg

  • do not use if carton was opened or if printed foil inner seal under bottle cap is torn or missing

  • store at room temperature 20º-25º C (68º-77º F)
Inactive Ingredients (Inactive ingredients)

calcium carbonate, confectioner’s sugar, corn syrup, corn syrup solids, FD&C red #40 aluminum lake, glycerin, hydrogenated coconut oil, natural masking flavor, soy lecithin, strawberry flavor, sucrose, water

  

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 (PRINCIPAL DISPLAY PANEL)

GREAT TASTE!



FAST & EFFECTIVE RELIEF



Kaopectate
®

Bismuth Subsalicylate • Anti-Diarrheal • Upset Stomach Reliever



Soft Chews



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



24 Soft Chews

Individually wrapped



Strawberry Flavor

FAST & EFFECTIVE RELIEF



Do not take maximum dose for more than 2 days per week.



Kramer Laboratories, Inc.

Bridgewater, NJ 08807

1-800-824-4894



502851

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)
  • fever

  • mucus in the stool

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)