ASPIRIN REGULAR STRENGTH REGULAR STRENGTH- aspirin tablet 
Major 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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Perrigo Aspirin Drug Facts

Active ingredient (in each tablet)

Aspirin 325 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever/fever reducer

Uses

temporarily relieves minor aches and pains due to:
muscular aches
the common cold
headache
minor pain of arthritis
premenstrual and menstrual cramps
toothache
temporarily reduces fever

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 (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

Do not use

if you have ever had an allergic reaction to 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 you are

taking a prescription drug for:

diabetes
gout
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
fever gets worse or lasts for more than 3 days
pain gets worse or lasts for more than 10 days
ringing in the ears or a loss of hearing occurs
redness or swelling is present
new symptoms occur

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

Directions

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

Inactive ingredients

starch

Questions or comments?

1-800-616-2471

Principal Display Panel

Aspirin

Regular Strength

Pain Reliever/Fever Reducer (NSAID)

Aid For Relief of Simple Headache, Neuralgia Pains,

Cold Discomforts, Muscular Aches

See New Warnings Information

325 mg. each

Aspirin 325 mg Tablets
ASPIRIN REGULAR STRENGTH  REGULAR STRENGTH
aspirin tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-2009
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN325 mg
Inactive Ingredients
Ingredient NameStrength
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
Product Characteristics
ColorWHITEScoreno score
ShapeROUNDSize11mm
FlavorImprint Code Aspirin;A1
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0904-2009-59100 in 1 BOX05/24/200603/01/2012
1100 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:0904-2009-40500 in 1 BOTTLE; Type 0: Not a Combination Product05/24/200606/15/2018
3NDC:0904-2009-60100 in 1 BOTTLE; Type 0: Not a Combination Product05/24/200609/30/2018
4NDC:0904-2009-801000 in 1 BOTTLE; Type 0: Not a Combination Product05/24/200603/01/2012
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34305/24/200609/30/2018
Labeler - Major Pharmaceuticals (191427277)
Registrant - Major Pharmaceuticals (191427277)
Establishment
NameAddressID/FEIBusiness Operations
Major Pharmaceuticals191427277REPACK(0904-2009)

Revised: 8/2018
 
Major Pharmaceuticals