NDC 55505-200 Kaopectate Max Peppermint Flavor Anti Diarrheal

Bismuth Subsalicylate

NDC Product Code 55505-200

NDC CODE: 55505-200

Proprietary Name: Kaopectate Max Peppermint Flavor Anti Diarrheal What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Bismuth Subsalicylate What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • This medication is used to treat occasional upset stomach, heartburn, and nausea. It is also used to treat diarrhea and help prevent travelers' diarrhea. It works by helping to slow the growth of bacteria that might be causing the diarrhea. This product should not be used to self-treat diarrhea if you also have a fever or blood/mucus in the stools. These could be signs of a serious health condition. Consult your doctor promptly for proper evaluation and treatment if you have these symptoms. This medication is used under a doctor's direction with other medication to treat stomach ulcers caused by a certain bacteria (Helicobacter pylori). Do not use this medication to self-treat ulcers. Bismuth subsalicylate is a salicylate. Salicylates can cause serious bleeding problems when used alone in patients with ulcers. Check the ingredients on the label even if you have used the product before. The manufacturer may have changed the ingredients. Also, products with similar names may contain different ingredients meant for different purposes. Taking the wrong product could harm you.

NDC Code Structure

  • 55505 - Kramer Laboratories
    • 55505-200 - Kaopectate Max Peppermint Flavor Anti Diarrheal

NDC 55505-200-36

Package Description: 236 mL in 1 BOTTLE

NDC Product Information

Kaopectate Max Peppermint Flavor Anti Diarrheal with NDC 55505-200 is a a human over the counter drug product labeled by Kramer Laboratories. The generic name of Kaopectate Max Peppermint Flavor Anti Diarrheal is bismuth subsalicylate. The product's dosage form is liquid and is administered via oral form.

Labeler Name: Kramer Laboratories

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Kaopectate Max Peppermint Flavor Anti Diarrheal Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • BISMUTH SUBSALICYLATE 525 mg/15mL

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • CARAMEL (UNII: T9D99G2B1R)
  • CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
  • FD&C RED NO. 40 (UNII: WZB9127XOA)
  • MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
  • SODIUM SALICYLATE (UNII: WIQ1H85SYP)
  • SORBIC ACID (UNII: X045WJ989B)
  • SUCROSE (UNII: C151H8M554)
  • WATER (UNII: 059QF0KO0R)
  • XANTHAN GUM (UNII: TTV12P4NEE)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.
  • Oral - Administration to or by way of the mouth.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Kramer Laboratories
Labeler Code: 55505
FDA Application Number: part335 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 11-01-2020 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2021 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Kaopectate Max Peppermint Flavor Anti Diarrheal Product Label Images

Kaopectate Max Peppermint Flavor Anti Diarrheal Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Otc - Purpose

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

Indications & Usage

  • Uses relievestraveler’s diarrheadiarrheaupset stomach due to overindulgence in food and drink, including:heartburnindigestionnauseagasbelchingfullness

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 ulcera bleeding problem bloody or black stool

Ask A Doctor Before Use If You Have

  • A sodium-restricted dietfevermucus in the stool

Otc - Ask Doctor

  • Ask a doctor or pharmacist before use if you are taking any drug fordiabetes goutarthritis 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 worseringing in the ears or loss of hearing occursdiarrhea 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 useonly use pre-measured dose cupadults and children 12 years of age and older:1 dose (30 mL) every hour as neededdo not exceed 4 doses (120 mL) in 24 hoursuse until diarrhea stops but not more than 2 dayschildren under 12 years: ask a doctordrink 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

* Please review the disclaimer below.