ASPIRIN- aspirin tablet 
CARDINAL HEALTH

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.

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Drug Facts

Active ingredient (in each tablet)

Aspirin 325mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever/fever reducer

temporarily relieves

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

Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you

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.

Directions

 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

image of label

ASPIRIN 
aspirin tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49781-095
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN325 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN (UNII: O8232NY3SJ)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TRIACETIN (UNII: XHX3C3X673)  
TALC (UNII: 7SEV7J4R1U)  
Product Characteristics
ColorwhiteScoreno score
ShapeROUNDSize10mm
FlavorImprint Code PH041
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49781-095-51100 in 1 BOTTLE
2NDC:49781-095-58300 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: 9/2014
Document Id: 688f138a-45d7-477f-988b-fb991ece1d4f
Set id: 077f3fb1-25d1-4ca6-b545-600849d7b40f
Version: 1
Effective Time: 20140924
 
CARDINAL HEALTH