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| Product NDC Code | 47682-406 | ||||
|---|---|---|---|---|---|
| Drug Name | Medi-first pep-t-med |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | TABLET, CHEWABLE | ||||
| RxCUI drug identifier | 308761 | ||||
| Application Number | part335 | ||||
| Labeler Name | Unifirst First Aid Corporation | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient (in each tablet) Bismuth Subsalicylate 262 mg (each tablet contains 102 mg salicylate)
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 chew or dissolve in mouth drink plenty of clear fluids to help prevent dehydration caused by diarrhea Adults and children: (12 years and over) chew 2 tablets every 1/2 to 1 hour as needed do not exceed 16 tablets in 24 hours use until diarrhea stops, but not more than 2 days Children under 12 years: Ask a doctor Children under 12 years: Do not give to children under 12 years of age.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients acacia gum, aspartame, calcium carbonate, D&C red #27 aluminum lake, dextrates, magnesium stearate, maltodextrin, microcrystalline cellulose, peppermint flavoring, silicon dioxide
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.Purpose Upset stomach reliever/antidiarrheal
Spl product data elements
Usually a list of ingredients in a drug product.Medi-First Pep-T-Med Bismuth Subsalicylate ASPARTAME CALCIUM CARBONATE CELLULOSE, MICROCRYSTALLINE D&C RED NO. 27 DEXTRATES MAGNESIUM STEARATE SILICON DIOXIDE BISMUTH SUBSALICYLATE SALICYLIC ACID ACACIA MALTODEXTRIN RH;046
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.Medi-First Pep-T-Med Label 36 Chewable Tablets Medi-First® PEP-T-MED Chewable Tablets Compare active ingredients to: Pepto Bismol® Registered Trademark of Proctor & Gamble Upset Stomach/Diarrhea Relief • Bismuth Subsalicylate 262mg Chew or crush tablets completely before swallowing. Do not swallow tablets whole. Tamper Evident MF PepTMed
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.Drug Facts
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 fever mucus in the stool
Ask doctor or pharmacist
Information about when a doctor or pharmacist should be consulted about drug/drug or drug/food interactions before using a drug product.Ask a doctor or pharmacist if you are taking any drug for anticoagulation (thinning of the blood) diabetes gout arthritis
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 bloody or black stool an ulcer a bleeding problem
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 accidental overdose, contact a physician or poison control center right away (1-800-222-1222).
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other information phenylketonurics: contains phenylalanine 1.1mg per tablet calcium content per tablet: 73 mg store at room temperature 59º-86ºF (15º-30ºC) tamper-evident sealed packets do not use any opened or torn packets
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions or comments? 1-800-634-7680
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 or lasts for more than 2 days 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 and harmless darkening of the tongue and/or stool may occur.
Pregnancy or breast feeding
Pregnancy or Breast feedingIf 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 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
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