NDC 0904-7704 Aspir Low

Aspirin

NDC Product Code 0904-7704

NDC Code: 0904-7704

Proprietary Name: Aspir Low 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.

Product Characteristics

Color(s):
YELLOW (C48330)
Shape: ROUND (C48348)
Size(s):
7 MM
Imprint(s):
HEART
Score: 1

NDC Code Structure

NDC 0904-7704-18

Package Description: 120 TABLET in 1 BOTTLE

NDC 0904-7704-70

Package Description: 250 TABLET in 1 BOTTLE

NDC 0904-7704-80

Package Description: 1000 TABLET in 1 BOTTLE

NDC Product Information

Aspir Low with NDC 0904-7704 is a a human over the counter drug product labeled by Major Pharmaceuticals. The generic name of Aspir Low is aspirin. The product's dosage form is tablet and is administered via oral form.

Labeler Name: Major Pharmaceuticals

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.

Aspir Low 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 81 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.

  • ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
  • CARNAUBA WAX (UNII: R12CBM0EIZ)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
  • D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
  • FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
  • METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J)
  • STARCH, CORN (UNII: O8232NY3SJ)
  • POLYSORBATE 80 (UNII: 6OZP39ZG8H)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • SODIUM LAURYL SULFATE (UNII: 368GB5141J)
  • TALC (UNII: 7SEV7J4R1U)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • TRIETHYL CITRATE (UNII: 8Z96QXD6UM)

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: Major Pharmaceuticals
Labeler Code: 0904
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 FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. 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: 05-24-2011 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: 12-31-2019 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.

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]

* Please review the disclaimer below.

Aspir Low Product Label Images

Aspir Low 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

Aspirin 81 mg (NSAID*)*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever

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.

Uses

■ temporarily relieves minor aches and pains■ for other uses, see your doctor, but do not use for more than 10 days without consulting your doctor because serious side effects may occur

Warnings

Reyeʼs syndrome: Children and teenagers who have or are recovering from chicken pox or flulikesymptoms should not use this product. When using this product, if changes in behavior withnausea and vomiting occur, consult a doctor because these symptoms could be an early sign ofReye’s syndrome; a rare but serious illness.Allergy alert: Aspirin may cause a severe allergic reaction, which may include:■ hives ■ facial swelling ■ shock ■ asthma (wheezing)Stomach bleeding warning: This product contains an NSAID, which may cause severe stomachbleeding. The chance is higher if you: ■ are age 60 or older ■ have had stomach ulcers or bleedingproblems ■ take a blood thinning (anticoagulant) or steroid drug ■ take other drugs containingprescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others) ■ have 3 or morealcoholic drinks every day while using this product ■ take more or for a longer time than directedDo not use ■ if you are allergic to aspirin or any other pain reliever/fever reducerAsk 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■ you have not been drinking fluids ■ you have lost a lot of fluid due to vomiting or diarrheaAsk a doctor or pharmacist before use if you are■ taking a prescription drug for diabetes, gout, or arthritis■ under a doctor’s care for any serious condition ■ taking any other drugStop use and ask a doctor if ■ you experience any of the following signs of stomach bleeding:■ feel faint ■ have bloody or black stools ■ vomit blood ■ 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■ redness or swelling is present in the painful area ■ any new symptoms appear■ ringing in the ears or a loss of hearing occursIf pregnant or breast-feeding, ask a health professional before use. It is especially important notto use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctorbecause it may cause problems in the unborn child or complications during delivery.

Directions

■ drink a full glass of water with each dose■ adults and children 12 years and over: take 4 to 8 tablets every 4 hours not to exceed 48 tablets in 24 hours unless directed by a doctor■ children under 12 years: consult a doctor

Inactive Ingredients

Anhydrous lactose, carnauba wax, colloidal silicon dioxide,croscarmellose sodium, D&C yellow #10 aluminum lake, iron oxide ochre, methacrylic acidcopolymer, microcrystalline cellulose, polysorbate 80, simethicone, sodium hydroxide, sodiumlauryl sulfate, talc, titanium dioxide, triethyl citrate

Questions?

Adverse Drug Event Call: (800) 616-2471

Other Information

■ store at 25°C (77°F) excursions permitted between 15°-30°C (59°-86°F)■ use by expiration date on package**Compare to the active ingredient in BAYER® Low Dose**This product is not manufactured or distributed by Bayer HealthCare LLC, owner of the registeredtrademark Bayer® Low Dose. Distributed by Major Pharmaceuticals31778 Enterprise Drive,Livonia, MI 48150 USA ASPIR LOW™ LOW STRENGTH 81mg ASPIRIN (NSAID)Enteric Coated1 1/4 gr. (81 mg) each AnalgesicSEE NEWWARNINGS INFORMATIONNEWTablet AppearanceTHIS PACKAGE FOR HOUSEHOLDS WITHOUT YOUNG CHILDRENMAJOR®

* Please review the disclaimer below.