NDC 42961-044 Zee Aspirin

Aspirin

NDC Product Code 42961-044

NDC CODE: 42961-044

Proprietary Name: Zee 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.

Product Characteristics

Color(s):
WHITE (C48325 - SNOW WHITE)
Shape: ROUND (C48348)
Size(s):
10 MM
Imprint(s):
FR21
Score: 1

NDC Code Structure

NDC 42961-044-03

Package Description: 50 CARTON in 1 CARTON > 125 PACKET in 1 CARTON (42961-044-02) > 2 TABLET in 1 PACKET (42961-044-01)

NDC 42961-044-04

Package Description: 24 CARTON in 1 BOX > 125 PACKET in 1 CARTON (42961-044-02) > 2 TABLET in 1 PACKET (42961-044-01)

NDC Product Information

Zee Aspirin with NDC 42961-044 is a a human over the counter drug product labeled by Cintas Corporation. The generic name of Zee Aspirin is aspirin. The product's dosage form is tablet and is administered via oral form.

Labeler Name: Cintas Corporation

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.

Zee 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

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.

  • CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
  • STARCH, CORN (UNII: O8232NY3SJ)
  • POVIDONE K29/32 (UNII: 390RMW2PEQ)

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: Cintas Corporation
Labeler Code: 42961
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: 01-06-2021 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: 12-31-2022 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".

* Please review the disclaimer below.

Zee 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

Otc - Active Ingredient

Active Ingredient/Tablet Aspirin 325 mg

Otc - Purpose

Purpose-Pain Reliever/Fever Reducer

Indications & Usage

Temporarily relieves pain due to: headache, muscular aches, cold, minor pain of arthritis.  Temporarily reduces fever

Dosage & Administration

Adults: Take 2 tablets every 4hours, not to exceed 12 caplets in 24 hoursChildren under 12 years, ask a doctor

Warnings

Warnings: Reye's syndrome: Children and teenagers should not use this medicine for chicken pox or flu symptoms before a doctor is consulted about Reye's syndrome, a rare but serious illness reported to be associated with aspirin.Stomach Bleeding Warning:This product contains nonsteroidal anti-inflammatory dugs (NSAIDs), which may cause 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 an NSAID (aspirin, ibuprofen, naproxen, or others.•    Take more or for a longer time than directedAllergy Alert-Do not use:•    if you are allergic to aspirin or any other salicylates•    If you have ever had an allergic reaction to any other pain reliever/fever reducer  Do not use:•    with any other pain reliever/fever reducer Ask doctor before using if you have:•    upset stomach or stomach pain•    ulcers•    bleeding problems•    high blood pressure•    heart or kidney disease•    taken a diuretic•    reached age 60 or olderAsk a doctor or pharmacist before use if you are:•    taking any other drug containing an NSAID (prescription or nonprescription)•    taking a blood thinning (anticoagulant) or steroid drugStop 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 present •    you feel faint, vomit blood, or have bloody or black stools.  These are signs of stomach bleeding

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding baby, 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.  Prompt medical attention is critical for adults as well as for  children even if you do not notice any signs or symptoms.

Inactive Ingredient

Inactive Ingredients: corn starch, microcrystalline cellulose,  povidone,

* Please review the disclaimer below.