NDC 52959-018 Regular Strength Aspirin Ec

NDC Product Code 52959-018

NDC 52959-018-00

Package Description: 100 TABLET, DELAYED RELEASE in 1 BOTTLE

NDC 52959-018-14

Package Description: 14 TABLET, DELAYED RELEASE in 1 BOTTLE

NDC 52959-018-20

Package Description: 20 TABLET, DELAYED RELEASE in 1 BOTTLE

NDC 52959-018-24

Package Description: 24 TABLET, DELAYED RELEASE in 1 BOTTLE

NDC 52959-018-30

Package Description: 30 TABLET, DELAYED RELEASE in 1 BOTTLE

NDC 52959-018-40

Package Description: 40 TABLET, DELAYED RELEASE in 1 BOTTLE

NDC 52959-018-60

Package Description: 60 TABLET, DELAYED RELEASE in 1 BOTTLE

NDC 52959-018-80

Package Description: 80 TABLET, DELAYED RELEASE in 1 BOTTLE

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

NDC Product Information

Regular Strength Aspirin Ec with NDC 52959-018 is a product labeled by H.j. Harkins Company, Inc.. The generic name of Regular Strength Aspirin Ec is . The product's dosage form is and is administered via form.

Labeler Name: H.j. Harkins Company, Inc.

Dosage Form: -

Product Type: 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.

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)
  • CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
  • D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
  • FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
  • HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)
  • HYPROMELLOSE 2910 (15 MPA.S) (UNII: 36SFW2JZ0W)
  • METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J)
  • CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
  • MINERAL OIL (UNII: T5L8T28FGP)
  • POLYSORBATE 80 (UNII: 6OZP39ZG8H)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • SODIUM LAURYL SULFATE (UNII: 368GB5141J)
  • TALC (UNII: 7SEV7J4R1U)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • TRIETHYL CITRATE (UNII: 8Z96QXD6UM)

Product Labeler Information

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

Labeler Name: H.j. Harkins Company, Inc.
Labeler Code: 52959
Start Marketing Date: 09-09-2011 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: 12-31-2018 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 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]

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Regular Strength Aspirin Ec Product Label Images

Regular Strength Aspirin Ec 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 (in each tablet)                  PurposeAspirin 325 mg (NSAID*).............................Pain reliever*nonsteroidal anti-inflammatory drug

Otc - Purpose

PurposePain reliever

Indications & Usage

  • Usesfor the temporary relief of minor aches and pains due toheadachecoldsmuscle painmenstrual paintoothacheminor pain of arthritisor as directed by your doctor

Warnings

  • WarningsReye'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 or 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 inclue:hivesfacial swellingshockasthma (wheezing)Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:are age 60 or olderhave had stomach ulcers or bleeding problemstake a blood thinning (anticoagulant) or steroid drugtake other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)have 3 or more alcoholic drinks every day while using this producttake more or for a longer time than directed

Otc - Do Not Use

  • Do not useif you are allergic to aspirin or any other pain reliever/fever reducer

Otc - Ask Doctor

  • Ask a doctor before use ifstomach bleeding warning applies to youyou have a history of stomach problems, such as heartburnyou have high blood pressure, heart disease, liver cirrhosis, or kidney diseaseyou are taking a diureticyou have asthmayou have not been drinking fluids

Otc - Ask Doctor/Pharmacist

  • Ask a doctor or pharmacist before use if you aretaking a prescription drug for diabetes, gout, or arthritistaking any other drugsunder a doctor's care for any serious condition

Otc - Stop Use

  • Stop use and ask a doctor ifyou experience any of the following signs of stomach bleeding:feel fainthave bloody or black stoolsvomit bloodhave stomach pain that does not get betterpain gets worse or lasts more than 10 daysfever gets worse or lasts more than 3 daysredness or swelling is present in the painful areaany new symptoms appearringing in the ears or a loss of hearing occurs

Otc - Pregnancy Or Breast Feeding

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.

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 (1-800-222-1222).

Dosage & Administration

  • Directionsdrink a full glass of water with each doseadults and children 12 years and over: take 1 to 2 tablets every 4 hours while symptoms last. Do not take more than 12 tablets in 24 hours unless directed by a doctorchildren under 12 years: consult a doctor

Storage And Handling

  • Other informationstore at 25°C (77°F) excursions permitted between 15°-30°C (59°-86°F)use by expiration date on package

Inactive Ingredient

Inactive ingredients corn starch, croscarmellose sodium, D-C yellow #10 aluminum lake, FD-C yellow #6 aluminum lake, hypromellose, methacrylic acid copolymer, microcrystalline cellulose, mineral oil, polysorbate 80, simethicone, sodium hydroxide, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate

Otc - Questions

Questions? To Report Adverse Drug Event Call: (800) 616-2471Repacked by:H.J. Harkins Company, Inc.Nipomo, CA 93444

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