NDC 49781-084 Leader Low Dose Aspirin

NDC Product Code 49781-084

NDC CODE: 49781-084

Proprietary Name: Leader Low Dose 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.

Product Characteristics

Color(s):
ORANGE (C48331)
Shape: ROUND (C48348)
Size(s):
8 MM
Imprint(s):
PH034
Score: 1

NDC Code Structure

  • 49781 - Cardinal Health

NDC 49781-084-99

Package Description: 1000 TABLET, CHEWABLE in 1 BOTTLE

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

NDC Product Information

Leader Low Dose Aspirin with NDC 49781-084 is a product labeled by Cardinal Health. The product's dosage form is and is administered via form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 318272.

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.

  • STARCH, CORN (UNII: O8232NY3SJ)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • SACCHARIN SODIUM (UNII: SB8ZUX40TY)
  • DEXTROSE MONOHYDRATE (UNII: LX22YL083G)

Product Labeler Information

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

Labeler Name: Cardinal Health
Labeler Code: 49781
Start Marketing Date: 09-20-2014 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: I - INACTIVATED, the listing data was inactivated by the FDA. 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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Leader Low Dose Aspirin Product Label Images

Leader Low Dose 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 81mg (NSAID)**nonsteroidal anti-inflammatory drug

Purpose

Pain reliever

Indications & Usage

  • For the temporary relief of minor aches and pains or as recommneded by your doctorask your doctor about other uses for this product

Warning

  • 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 includefacial swellingshockhivesasthma (wheezing)Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if youare age 60 or oldertake a blood thinning (anticoagulant) or steroid drugtake other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)take more or for a longer time than directedhave had stomach ulcers or bleeding problemshave 3 or more alcoholic drinks every day while using this producttake more or for a longer time than directed

Do Not Use

  • If you are allergic to aspirin or any other pain reliever/fever reducerthis product for at least 7 days after tonsillectomy or oral surgery unless directed by a doctor

Ask A Doctor Before Use If

  • Stomach bleeding warning applies to youyou have a history of stomach problems, such as heartburnyou are taking a diureticyou have asthmayou have high blood pressure, heart disease, liver cirrhosis or kidney disease

Ask A Doctor Or Pharmacist Before Use If You Are

  • Taking a prescription drug forgoutdiabetesarthritis

Stop Use And Ask A Doctor If

  • You experience any of the following signs of stomach bleeding:feel faintvomit bloodhave bloody or black stoolshave stomach pain that does not get betteran allergic reaction occursany new symptoms occurpain gets worse or lasts more than 10 daysredness or swelling is presentringing in the ears or loss of hearing occursThese could be signs of a serious illness.

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 accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

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

Other Information

  • Store at room temperature (150-300C)aviod excess heat and moisture

Inactive Ingredients

Corn starch, dextrose monohydrate, FD&c yellow #6, flavor, silicon dioxide, sodium saccharine and stearic acid

* Please review the disclaimer below.