NDC 47682-621 Medi-first Aspirin

Aspirin

NDC Product Code 47682-621

NDC CODE: 47682-621

Proprietary Name: Medi-first Aspirin 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: Aspirin 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.

  • Aspirin is used to reduce fever and relieve mild to moderate pain from conditions such as muscle aches, toothaches, common cold, and headaches. It may also be used to reduce pain and swelling in conditions such as arthritis. Aspirin is known as a salicylate and a nonsteroidal anti-inflammatory drug (NSAID). It works by blocking a certain natural substance in your body to reduce pain and swelling. Consult your doctor before treating a child younger than 12 years. Your doctor may direct you to take a low dose of aspirin to prevent blood clots. This effect reduces the risk of stroke and heart attack. If you have recently had surgery on clogged arteries (such as bypass surgery, carotid endarterectomy, coronary stent), your doctor may direct you to use aspirin in low doses as a blood thinner to prevent blood clots.

NDC Code Structure

NDC 47682-621-13

Package Description: 250 PACKET in 1 BOX > 2 TABLET, COATED in 1 PACKET

NDC 47682-621-33

Package Description: 50 PACKET in 1 BOX > 2 TABLET, COATED in 1 PACKET

NDC 47682-621-48

Package Description: 125 PACKET in 1 BOX > 2 TABLET, COATED in 1 PACKET

NDC 47682-621-50

Package Description: 25 PACKET in 1 BOX > 2 TABLET, COATED in 1 PACKET

NDC 47682-621-64

Package Description: 12 PACKET in 1 BOX > 2 TABLET, COATED in 1 PACKET

NDC 47682-621-99

Package Description: 2 TABLET, COATED in 1 PACKET

NDC Product Information

Medi-first Aspirin with NDC 47682-621 is a a human over the counter drug product labeled by Unifirst First Aid Corporation. The generic name of Medi-first Aspirin is aspirin. The product's dosage form is tablet, coated and is administered via oral form.

Labeler Name: Unifirst First Aid Corporation

Dosage Form: Tablet, Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is covered with a designated coating.

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.

Medi-first Aspirin 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.

  • ASPIRIN 325 mg/1

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.

Product Labeler Information

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

Labeler Name: Unifirst First Aid Corporation
Labeler Code: 47682
FDA Application Number: part343 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 NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. 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: 01-04-2021 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.

Medi-first Aspirin 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

Active Ingredient (In Each Tablet)

Aspirin (NSAID*) 325 mg*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever/fever reducer

Uses

  • Temporarily relieves minor aches and pains due to: headache minor pain of arthritis colds menstrual pain muscle pain toothacheTemporarily reduces fever.

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:

Aspirin may cause a severe allergic reaction which may include:hives

facial swelling

asthma (wheezing)

shock
If an allergic reaction occurs, stop use and seek medical help right away.

Stomach Bleeding Warning:

This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:are age 60 or older

have had stomach ulcers or bleeding problems

take a blood thinning (anticoagulant) or steroid drug

take other drugs containing prescription or nonprescription

NSAIDs (aspirin, ibuprofen, naproxen, or others)

have 3 or more alcohol drinks every day while

using this product

take more or for a longer time than directed

Do Not Use

  • If you are allergic to aspirin or to any other pain reliever/fever reducer if you ever had an allergic reaction to this product or any of its ingredients

Ask A Doctor Before Use If

■ stomach bleeding warning applies to you■ you have a history of stomach problems such as heartburn■ you have high blood pressure, heart disease, liver cirrhosis, or kidney disease■ you are taking a diuretic■ you have asthma

Ask A Doctor Or Pharmacist Before Use If You Are Taking A Prescription Drug For

  • Goutdiabetesarthritis

Stop Use And Ask A Doctor If

  • You experience any of the following signs of stomach bleeding:■ feel faint ■ vomit blood ■ have bloody or black stools ■ have stomach pain that does not get better pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days if ringing in the ears or loss of hearing occurs redness or swelling is present in the painful area any new symptoms occur

If Pregnant Or Breast-Feeding,

Ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

Keep Out Of Reach Of Children.

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

Directions

  • Drink a full glass of water with each doseAdults and children: Take 1 or 2 tablets with water every 4 hours or 3 tablets every 6 hours, not
  • (12 years and older) to exceed 12 tablets in 24 hours
  • Children under 12 years: Do not give to children under 12 years of age unless directed by a doctor.

Other Information

  • Use by expiration date on packagestore at 77ºF (25ºC); excursions permitted between 59º-86ºF (15° - 30°C)avoid excessive heat and humiditytamper evident sealed packetsdo not use any opened or torn packets

Inactive Ingredients

Corn starch, hypromellose, polyethylene glycol, propylene glycol

Medique Products Aspirin Label

Collect MediBucksSee inside panel for more detailsMedique®Aspirin5 Grain (325 mg)Anti-Inflammatory (NSAID)Anti-inflamatorio (AINE)• Pain Reliever/Fever Reducer • Asppirin 325 mgAlivia el Dolor/Reduce la Fiebre • Aspirina 325 mgThis Package is for Households without Young Children.Este Paquete Para Hogares Sin Ninos Pequenos.Pull to OpenTira Para Abrir500 Tablets (250 x 2)Tamper Evident Unit Dose PacketsEmpaquetado con Sellado Evidente en Dosis Unitarias

Medi-First Aspirin Label

250 Tablets(125 x 2)Medi-First®Aspirin 5 Grain (325 mg)Compare Acrive Ingredients to:Genuine Bayer®Registered Trademark of Pfizer Consumerull To OpenAches, Fever • Aspirin 325 mgPain Reliever/Fever Reducer (NSAID)This Package is for Households without Young Children.Tamper Evident Unit Dose Packets

Medi-First Plus Aspirin Label

100 Tablets(50 x 2's)Medi First® PlusAspirinAspirin 325 mg (NSAID)Pull Yo OpenThis package is for Households without Young Children.Pain Reliever/Fever ReducerCompare active ibgredient to:Genuine Bayer®Registered Trademark of Bayer Corp.Tamper Evident Unit Dose Packets

* Please review the disclaimer below.