NDC 16103-356 Adult Low Dose Aspirin

Product Information

What is NDC 16103-356?

The NDC code 16103-356 is assigned by the FDA to the product Adult Low Dose Aspirin which is product labeled by Pharbest Pharmaceuticals, Inc.. The product's dosage form is and is administered via form. The product is distributed in 2 packages with assigned NDC codes 16103-356-09 1 bottle, plastic in 1 carton / 120 tablet, delayed release in 1 bottle, plastic, 16103-356-11 1000 tablet, delayed release in 1 bottle, plastic . This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information, RxNorm crosswalk and the complete product label.

NDC Product Code16103-356
Proprietary Name 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.
Adult Low Dose Aspirin
Product Labeler Information What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.
Pharbest Pharmaceuticals, Inc.
Labeler Code16103
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
01-12-2007
Listing Expiration Date 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.
12-31-2022
Exclude Flag 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".
I
NDC Code Structure

What are the uses for Adult Low Dose Aspirin?


Product Characteristics

Color(s)YELLOW (C48330 - YELLOW COLOR)
ShapeROUND (C48348)
Size(s)8 MM
Imprint(s)PH023
Score1

Product Packages

NDC Code 16103-356-09

Package Description: 1 BOTTLE, PLASTIC in 1 CARTON / 120 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC

Price per Unit: $0.01396 per EA

NDC Code 16103-356-11

Package Description: 1000 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC

Price per Unit: $0.01396 per EA

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

Product Details

Adult Low Dose Aspirin Active Ingredients UNII Codes

NDC to RxNorm Crosswalk

What is RxNorm? RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:

Adult Low Dose Aspirin Inactive Ingredients UNII Codes

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.

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Patient Education

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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Adult Low Dose Aspirin Product Label

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Label Table of Contents



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 recommended by your doctor. Because of its delayed action, this product may not provide fast relief of headache or other symptoms needing immediate relief.
  • ask your doctor about other uses for this product.

Warnings



Reye's syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this products. 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 include:
  • hives
  • asthma (wheezing)
  • facial swelling
  • shock
  • Stomach bleeding warning: This product contains an NSAID, which may cause severe 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 prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
    • have 3 or more alcoholic drinks every day while using this product
    • take more or for a longer time than directed

Do Not Use If



You have ever had an allergic reaction to aspirin or any other pain reliever/fever reducer

Ask A Doctor Before Use If



  • the 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 have asthma
  • you are taking a diuretic

Ask A Doctor Or Pharmacist Before Use If You Are Taking A Prescription Drug For:



  • gout
  • diabetes
  • arthritis

Stop Use And Ask A Doctor If:



  • you experience any of the following signs of stomach bleeding: feel faint, vomit blood, have bloody or black stools, have stomach pain that does not get better
  • allergic reaction occurs
  • pain gets worse or lasts more than 10 days
  • redness or swelling is present
  • any new symptoms occur
  • ringing in the ears or loss of hearing occurs
  • These could be signs of a serious condition.

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 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 while symptoms persist. Do not to exceed 48 tablets in 24 hors or as directed by a physician
  • children under 12 years: consult a physician

Other Information



  • Tamper Evident: Do not use if safety seal under cap is broken or missing
  • store at room temperature (15°-30°C)
  • avoid excess heat and moisture

Questions?



Adverse drug event call: (866) 562-2756

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