NDC 12634-120 Aspirin

Product Information

What is NDC 12634-120?

The NDC code 12634-120 is assigned by the FDA to the product Aspirin which is product labeled by Apotheca, Inc. The product's dosage form is and is administered via form. The product is distributed in 4 packages with assigned NDC codes 12634-120-01 100 tablet in 1 bottle , 12634-120-10 1000 tablet in 1 bottle , 12634-120-60 60 tablet in 1 bottle , 12634-120-74 24 tablet in 1 bottle . 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 Code12634-120
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.
Aspirin
Product Labeler Information What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.
Apotheca, Inc
Labeler Code12634
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.
04-15-1983
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.
12-31-2019
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 Aspirin?


Product Characteristics

Color(s)WHITE (C48325)
ShapeROUND (C48348)
Size(s)10 MM
Imprint(s)TCL;011
Score1

Product Packages

NDC Code 12634-120-01

Package Description: 100 TABLET in 1 BOTTLE

NDC Code 12634-120-10

Package Description: 1000 TABLET in 1 BOTTLE

NDC Code 12634-120-60

Package Description: 60 TABLET in 1 BOTTLE

NDC Code 12634-120-74

Package Description: 24 TABLET in 1 BOTTLE

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

Product Details

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:

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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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



Each tablet contains Aspirin 325 mg
Aspirin (Acetysalicylic Acid) 325 mg (5gr.) (NSAID)*


Purpose



Pain Reliever

Uses:

For the temporary relief of minor aches and pains due to:

headache, colds, muscle pain, menstrual pain, toothache, minor pain of arthritis or as directed by your doctor.


Keep Out Of Reach Of Children



Keep out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.


Uses



Provides temporary relief of

  • headache
  • pain and fever of colds
  • muscle pain
  • toothache
  • menstrual pain
  • minor pain of arthritis.

Warnings



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 include, hives, facial swelling, shock, asthma (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 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.


Dosage & Administration



Drink a full glass of water with each dose

Adults 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 doctor.

Children under 12 years: consult a doctor


Principal Display Panel



MANUFACTURED BY:

Time-Cap Labs, Inc

Farmingdale, NY 11735

Repackaged & Relabeled by:

Apotheca, Inc

Phoenix, AZ 85006

Repackaged & Relabeled for:

RejuviLife

Phoenix, AZ 85006

NDC 12634-120-74

ASPIRIN

ANALGESIC

PAIN RELIEVER

REJUVILIFE

24 TABLETS

325 MG (5 GR EACH)


* Please review the disclaimer below.