Kaopectate Liquid
FDA Label NDC 55505-229

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Kramer Laboratories for the product Kaopectate (NDC 55505-229). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient (per 15 ml), purposes, uses, warnings, do not take if you are, do not use if you have, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient (Per 15 Ml)

Bismuth subsalicylate 525 mg

Purposes

Anti-diarrheal
Upset stomach reliever

Uses

relieves:

  • traveler's diarrhea
  • diarrhea
  • upset stomach due to overindulgence in food and drink

    • including:

    • heartburn
    • indigestion
    • nausea
    • gas
    • belching
    • fullness

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.

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

Ask A Doctor Before Use If You Have

  • a sodium-restricted diet
  • fever
  • mucus in the stool

Ask A Doctor Or Pharmacist Before Use If You Are

taking any drug for

  • diabetes
  • gout
  • arthritis
  • anticoagulation (thinning the blood)

When Using This Product

a temporary, but harmless, darkening of the stool and/or tongue may occur

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

If Pregnant Or Breast-Feeding

ask a health professional before use.

Keep Out Of Reach Of Children

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

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 30 mL dose cup contains: sodium 13 mg and salicylate 507 mg
  • store at room temperature 20°-25° C (68°-77° F)

Inactive Ingredients

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

Principal Display Panel

EXTRA
STRENGTH

2X
THE MEDICINE
PER DOSE

Kaopectate®
Bismuth Subsalicylate 525 mg
● Anti-Diarrheal ● Upset stomach Reliever

Diarrhea &
Upset Stomach

√ Begins controlling symptoms from the first dose
√ Twice the medicine as regular strength Kaopectate
√ Quickly relieves urgency, gas, and cramping

11 fl oz (325 mL)

Peppermint Flavor

682PPT11KA0LB

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DO NOT USE IF INNER SEAL IS BROKEN OR MISSING
Kramer Laboratories, Bridgewater, NJ 08807 1-800-824-4894
K0825        682PPT11KA0LB

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DRUG FACTS AND INFORMATION

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