NDC 69103-2501 Aspirin 5 Grain

Aspirin

NDC Product Code 69103-2501

NDC CODE: 69103-2501

Proprietary Name: Aspirin 5 Grain 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 69103-2501-5

Package Description: 250 PACKET in 1 CARTON > 2 TABLET in 1 PACKET

NDC 69103-2501-6

Package Description: 100 PACKET in 1 CARTON > 2 TABLET in 1 PACKET

NDC Product Information

Aspirin 5 Grain with NDC 69103-2501 is a a human over the counter drug product labeled by Provision Medical Products. The generic name of Aspirin 5 Grain is aspirin. The product's dosage form is tablet and is administered via oral form.

Labeler Name: Provision Medical Products

Dosage Form: Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.

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.

Aspirin 5 Grain 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

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.

  • POVIDONE K30 (UNII: U725QWY32X)
  • COLLOIDAL SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • STARCH, CORN (UNII: O8232NY3SJ)
  • STEARIC ACID (UNII: 4ELV7Z65AP)

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: Provision Medical Products
Labeler Code: 69103
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: 03-31-2015 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 - NO 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

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Information for Patients

Aspirin

Aspirin is pronounced as (as' pir in)

Why is aspirin medication prescribed?
Prescription aspirin is used to relieve the symptoms of rheumatoid arthritis (arthritis caused by swelling of the lining of the joints), osteoarthritis (arthritis caused ...
[Read More]

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Aspirin 5 Grain Product Label Images

Aspirin 5 Grain 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

Indications & Usage

Uses:temporarily relieves pains due to:•headache • minor pain of arthritis•muscular aches • temporarily reduces fever•common cold

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a healthprofessional before use.IT IS ESPECIALLY IMPORTANT NOT TOUSE ASPIRIN DURING THE LAST 3MONTHS OF PREGNANCY UNLESSSPECIFICALLY DIRECTED TO DO SO BYA DOCTOR, BECAUSE IT MAY CAUSEPROBLEMS IN THE UNBORN CHILD ORCOMPLICATIONS DURING DELIVERY.

Otc - Keep Out Of Reach Of Children

KEEP OUT OF REACH OF CHILDREN. Incase of overdose, get medical help orcontact a Poison Control Center rightaway. Prompt medical attention iscritical for adults as well as for childreneven if you do not notice any signs orsymptoms.

Warnings

Warnings:Reye's syndrome: Children and teenagers should notuse this medicine for chicken pox or -u symptomsbefore a doctor is consulted about Reye's syndrome, arare but serious illness reported to be associated withaspirin.Alcohol Warning: If you consume 3 or more alcoholicdrinks every day, ask your doctor whether you shouldtake aspirin or other pain relievers/fever reducers.Aspirin may cause stomach bleeding.Do not use:•if you are allergic to aspirin•with any other pain reliever/fever reducer•if you have ever had an allergic reaction to anyother pain reliever/fever reducer•for pain for more than 10 days or for fever formore than 3 days unless directed by a doctor•with any other product containing aspirinAsk a doctor before using if you have:•asthma • gastric ulcers • bleeding problems•stomach problems (such as heartburn, upset stomachor stomach pain)Ask a doctor or pharmacist before use if you aretaking a prescription drug for:• anticoagulation(thinning of blood)• diabetes • gout • arthritisStop use and ask a doctor if:•ringing in the ears or loss of hearing occurs•pain or fever persists or gets worse•new symptoms occur•redness or swelling is presentWhen using this product do not exceedrecommended dose

Dosage & Administration

Directions:Adults and children 12 years of age and older take 2 tablets every 4 to 6hours asneeded, do not exceed 12 tablets in 24 hours, or as directed bya doctor.Children under 12 years consult adoctor.Do not use more than directed

Inactive Ingredient

Inactive Ingredients:corn starch, povidone, silicon dioxideand stearic acid.

Otc - Active Ingredient

ACTIVE INGREDIENT-ASPIRIN 325 MG

Otc - Purpose

PAIN RELIEVER/FEVER REDUCER

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