ASPIRIN- aspirin tablet 
PAR Pharmaceuticals

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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Aspirin 325mg

Active ingredient(s)

Aspirin 325mg

Purpose

Pain reliever

Use(s)

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

  • headache 
  • toothache
  • muscle pain 
  • minor arthritis pain  
  • menstrual pain 
  • colds
  • or as recommended by a doctor.

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 
  • asthma (wheezing) 
  • 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 (anti-coagulant) 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

For external use only

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 have high blood pressure, heart disease, liver cirrhosis, or kidney disease 
  • you are taking a diuretic 
  • you have asthma

Ask a doctor or pharmacist before use if

taking a prescription drug for diabetes, gout, or arthritis

When using this product

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.
  • new symptoms occur 
  • ringing in the ears or loss of hearing occurs 
  • redness or swelling is present 
  • pain gets worse or lasts more than 10 days 
  • fever gets worse or lasts more than 3 days  These could be signs of a serious condition.

Pregnancy/Breastfeeding

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 overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

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: ask a doctor

Other information

save carton for full directions and warnings  

Storage

  • store at room temperature   
  • do not use if imprinted safety seal under cap is broken or missing

Inactive ingredients

corn starch, croscarmellose sodium, D&C yellow #10 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, methacrylic acid copolymer, microcrystalline cellulose, mineral oil, polysorbate 80, simethicone, sodium hydroxide, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate

Questions

Call 1-888-952-0050 Monday through Friday 9AM – 5PM EST.   

Principal Display Panel

Aspirin 325mg

Aspirin 325mg


ASPIRIN 
aspirin tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0603-0168
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)  
HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P)  
STARCH, CORN (UNII: O8232NY3SJ)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
HYPROMELLOSE PHTHALATE (31% PHTHALATE, 40 CST) (UNII: G4U024CQK6)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
MINERAL OIL (UNII: T5L8T28FGP)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
Product Characteristics
ColorORANGEScoreno score
ShapeROUNDSize8mm
FlavorImprint Code A
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0603-0168-21100 in 1 BOTTLE; Type 0: Not a Combination Product11/03/200905/31/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34311/03/200905/31/2018
Labeler - PAR Pharmaceuticals (092733690)

Revised: 10/2020
 
PAR Pharmaceuticals