Kaopectate Max Peppermint Flavor Anti Diarrheal Liquid
FDA Label NDC 55505-200

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 Max Peppermint Flavor Anti Diarrheal (NDC 55505-200). 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 otc - purpose, indications & usage, other, do not take if you are, do not use if you have, ask a doctor before use if you have, otc - ask doctor, otc - when using, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Purpose

Active ingredient (per 15 mL)Purposes
Bismuth subsalicylate 525 mgAnti-diarrheal
Upset stomach reliever

Indications & Usage

Uses relieves

  • traveler’s diarrhea
  • diarrhea
  • upset stomach due to overindulgence in food and drink, including:
    • heartburn
    • indigestion
    • nausea
    • gas
    • belching
    • fullness

Other

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.

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

Otc - Ask Doctor

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

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

Otc - When Using

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

Otc - Pregnancy Or Breast Feeding

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

Otc - Keep Out Of Reach Of Children

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 15 mL dose cup contains: sodium 10 mg
  •  do not use if inner seal is broken or missing
  •  store at room temperature 20°-25° C (68°-77° F)

Inactive Ingredients

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

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

P003H11000

Front Panel (Front)

Front Panel (Front)

Kramer Laboratories, Inc.
Bridgewater, NJ 08807
1-800-824-4894

LOT EXP

P003H12000

Rear Panel (Rear)

Rear Panel (Rear)


   

  

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