ASPIRIN THIN COATED- 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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Quality Plus 44-157

Active ingredient (in each tablet)

Aspirin 325 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever/fever reducer


Uses

temporary relieves:

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

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 more or for a longer time than directed
  • take a blood thinning (anticoagulant) or steroid drug
  • take other drugs containing prescription and nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
  • 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

  • the stomach bleeding warning applies to you
  • you have liver cirrhosis
  • you have a history of stomach problems, such as heartburn
  • you have heart or kidney disease
  • you are taking a diuretic
  • you have high blood pressure
  • you have asthma

Ask a doctor or pharmacist before use if you are

taking a prescription drug for

  • gout
  • diabetes
  • arthiritis

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
  • redness or swelling is present
  • any new symptoms occur
  • fever gets worse or lasts more than 3 days
  • ringing in the ears or loss of hearing occurs

If pregnant or breast-feeding,

ask a health professional before use.  It is especially important not tuse 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 (-1800-222-1222) 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 or 3 tablets every 6 hours, not to exceed 12 tablets in 24 hours.
  • children under 12 years: consult a doctor

Other information

  • use by expiration date on package
  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)

Inactive ingredients

corn starch, hypromellose, polyetheylene glycol, propylene glycol

Questions or comments?

1-800-616-2471

Principal display panel

MAJOR PHARMACEUTICALS

NDC 0904-2019-59

Compare to the active ingredient in Genuine Bayer® Aspirin

Aspirin
325 mg

Pain reliever/
Fever reducer (NSAID)

100 Tablets

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

†This product is not manufactured or distributed by Bayer® HealthCare LLC, owner of the registered trademark Genuine Bayer® Aspirin.
50844    ORG091315712

Aspirin 325 mg tablets
ASPIRIN  THIN COATED
aspirin tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-2019
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)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
Product Characteristics
ColorWHITEScoreno score
ShapeROUNDSize11mm
FlavorImprint Code ASPIRIN;44157
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0904-2019-59100 in 1 BOX05/07/201408/20/2019
1100 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34305/07/201408/20/2019
Labeler - Major Pharmaceuticals (191427277)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867837MANUFACTURE(0904-2019)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.967626305PACK(0904-2019)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.038154464PACK(0904-2019)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.868734088PACK(0904-2019)

Revised: 8/2019
 
Major Pharmaceuticals