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Dosage form: tablet
Ingredients: ASPIRIN 325mg
NDC Code: 49781-095

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Facts

Active ingredient (in each tablet)

Aspirin 325mg (NSAID)*

*nonsteroidal anti-inflammatory drug


Pain reliever/fever reducer

temporarily relieves

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

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

  • facial swelling
  • shock
  • hives
  • 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
  • take a blood thinning (anticoagulant) or steroid drug
  • take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
  • take more or for a longer time than directed
  • have had stomach ulcers or bleeding problems
  • have 3 or more alcoholic drinks every day while using this product

Do not use 

if you are allergic to aspirin or any other pain reliever/fever reducer

Ask a doctor before use if
  • stomach bleeding warning applies to you
  • you have a history of stomach problems, such as heartburn
  • you are taking a diuretic
  • you have asthma
  • you 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 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
  • an allergic reaction occurs. Seek medical help right away.
  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 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 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 (1-8000-222-1222) right away.

  • drink a full glass of water with each dose
 adults and children 12 years and over take 1 to 2 tablets every 4 hours or 3 tablets every 6 hours, not to exceed 12 tablets in 24 hours
 children under 12 years consult a doctor

Other information store at room temperature

Inactive ingredients

Corn starch, hypromellose, microcrystalline cellulose, stearic acid, triacetin & talc

Questions or comments?

Adverse drug event call: (866) 562-2756 

Compare to Genuine Bayer®Aspirin active ingredient

Leader Genuine Aspirin 325 mg

Pain Reliever/Fever Reducer (NSAID)

Fast, Safe Pain Relief

aspirin tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49781-095
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Inactive Ingredients
Ingredient NameStrength
Product Characteristics
ColorwhiteScoreno score
FlavorImprint CodePH041
#Item CodePackage Description
1NDC:49781-095-51100 TABLET (TABLET) in 1 BOTTLE
2NDC:49781-095-58300 TABLET (TABLET) in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34309/20/2014
Labeler - CARDINAL HEALTH (097537435)
Registrant - Pharbest Pharmaceuticals, Inc. (557054835)

Revised: 09/2014

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.