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

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

Stomach bleeding warning: This product contains a nonsteroidal anti-inflammatory drug (NSAID), which may cause severe stomach bleeding. The chance is higher if you

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

  • 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

  • an allergic reaction occurs. Seek medical help right away.
  • 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
  • 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 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 right away.

Directions

 adults and children 12 years and over take 1 to 2 tablets every 4 hours while symptoms persist. Do not exceed 12 tablets in 24 hours unless diretced by a physician. 
 children under 12 years consult a physician

Other information

Inactive ingredients

croscarmellose sodium, D&C yellow #10 Lake, FD&C red #6, hypromellose, methacrylic acid copolymer, microcrystalline cellulose, polyethylene glycol, propylene glycol, sodium lauryl sulfate, starch, stearic acid, talc, titanium dioxide, triacetin. 

Questions or comments?

Adverse drug event call: 1-866-562-2756 

Compare to Ecotrin® active ingredient

Leader 

Regular Strength Aspirin

Enteric Coated Aspirin 325 mg

Pain Reliever (NSAID)

image of label

ASPIRIN 
aspirin tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49781-096
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN325 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
D&C RED NO. 6 (UNII: 481744AI4O)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1) (UNII: 74G4R6TH13)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
STARCH, CORN (UNII: O8232NY3SJ)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TRIACETIN (UNII: XHX3C3X673)  
Product Characteristics
ColororangeScoreno score
ShapeROUNDSize10mm
FlavorImprint Code PH024
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49781-096-531 in 1 CARTON
1125 in 1 BOTTLE
2NDC:49781-096-58300 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: 761b3a57-a538-4698-a09d-2917a29081b5
Set id: 24ab6288-a0f1-475f-963f-0a75994954ae
Version: 1
Effective Time: 20140927
 
CARDINAL HEALTH