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Kaopectate peppermint flavor anti diarrheal - Medication Information

Product NDC Code 55505-199
Drug Name

Kaopectate peppermint flavor anti diarrheal

Type Brand
Pharm Class Bismuth [CS],
Bismuth [EPC]
Active Ingredients
Bismuth subsalicylate 262 mg/15ml
Route ORAL
Dosage Form LIQUID
RxCUI drug identifier 308762,
642346
Application Number M008
Labeler Name Kramer Laboratories
Packages
Package NDC Code Description
55505-199-36 236 ml in 1 bottle (55505-199-36)
55505-199-64 325 ml in 1 bottle (55505-199-64)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active ingredient (per 15 mL) Purposes Bismuth subsalicylate 262 mg Anti-diarrheal Upset stomach reliever
Active ingredient (per 15 mL)Purposes
Bismuth subsalicylate 262 mgAnti-diarrheal Upset stomach reliever

Dosage and administration

Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.
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 1/2 hour to 1 hour as needed. do not exceed 8 doses (240 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

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive Ingredients carboxymethylcellulose sodium, FD&C Red No. 40, flavor microcrystalline cellulose, purified water, sodium salicylate, sorbic acid, sucrose, xanthan gum

Indications and usage

A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.
Uses relieves: traveler’s diarrhea diarrhea upset stomach due to overindulgence in food and drink, including: heartburn indigestion nausea gas belching fullness

Purpose

Information about the drug product’s indications for use.
Active ingredient (per 15 mL) Purposes Bismuth subsalicylate 262 mg Anti-diarrheal Upset stomach reliever
Active ingredient (per 15 mL)Purposes
Bismuth subsalicylate 262 mgAnti-diarrheal Upset stomach reliever

Spl product data elements

Usually a list of ingredients in a drug product.
Kaopectate Peppermint Flavor Anti Diarrheal bismuth subsalicylate BISMUTH SUBSALICYLATE BISMUTH CATION Carboxymethylcellulose Sodium, Unspecified Fd&C Red No. 40 Microcrystalline Cellulose SODIUM SALICYLATE SORBIC ACID SUCROSE WATER XANTHAN GUM Front Label Back Label

Package label principal display panel

The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.
Principal Display Panel NEW IMPROVED TASTE! Kaopectate ® Bismuth Subsalicylate 262 MG • Anti-Diarrheal • Upset Stomach Reliever 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 11 fl oz (325mL) Peppermint Flavor 681PPT11KA0 F Kaopectate Peppermint 11 oz Do not use if inner seal is broken or missing Kramer Laboratories Bridgewater, NJ 08807 1-800-824-4894 Lot: Exp: PEEL CORNER TO READ COMPLETE DRUG FACTS AND INFORMATION 681PPT11KA0LB

Spl unclassified section

Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.
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. Other Information each 15 mL dose cup contains: sodium 6 mg and salicylate 135mg store at room temperature 20º-25º C (68º-77º F)

Ask doctor

Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.
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)

Do not use

Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.
Do not use if you have an ulcer a bleeding problem bloody or black stool

Keep out of reach of children

Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Stop use

Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.
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

When using

Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.
When using this product a temporary, but harmless, darkening of the stool and/or tongue may occur

Pregnancy or breast feeding

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

Warnings

Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.
Warnings

Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API