Drug Facts

Drug Facts
SPL v5
SPL
SPL Set ID e7218045-a593-485b-a5ba-03f3b35cbec4
Route
ORAL
Published
Effective Date 2022-12-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Bismuth Cation (525 mg)
Inactive Ingredients
Caramel Carboxymethylcellulose Sodium, Unspecified Form Fd&c Red No. 40 Microcrystalline Cellulose Sodium Salicylate Sorbic Acid Sucrose Water Xanthan Gum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 2020-11-01 Until 2027-01-01

Description

Active ingredient (per 15 mL) Purposes Bismuth subsalicylate 525 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 525 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 525 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 hour as needed
    • do not exceed 4 doses (120 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 10 mg
  •  do not use if inner seal is broken or missing

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

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

Kaopectate ®

Bismuth Subsalicylate



• Anti-Diarrheal • Upset Stomach Reliever



MAX



Diarrhea & 

Upset Stomach



✓ Begins controlling symptoms from the first dose

✓ Twice the medicine as regular strength Kaopectate

✓ Quickly relieves urgency, gas, and cramping



8 fl oz (236 mL)



Peppermint Flavor



200H130

Peel



Kramer Laboratories, Inc.


Bridgewater, NJ 08807

1-800-824-4894



LOT EXP



P003H12000



   

  

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 525 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 hour as needed
    • do not exceed 4 doses (120 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 10 mg
  •  do not use if inner seal is broken or missing

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

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

Kaopectate ®

Bismuth Subsalicylate



• Anti-Diarrheal • Upset Stomach Reliever



MAX



Diarrhea & 

Upset Stomach



✓ Begins controlling symptoms from the first dose

✓ Twice the medicine as regular strength Kaopectate

✓ Quickly relieves urgency, gas, and cramping



8 fl oz (236 mL)



Peppermint Flavor



200H130

Peel



Kramer Laboratories, Inc.


Bridgewater, NJ 08807

1-800-824-4894



LOT EXP



P003H12000



   

  

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)