ASPIRIN- aspirin 325 mg tablet 
Allegiant Health

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Drug Facts

Active ingredient

Aspirin 325 mg (NSAID*)
*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever

Uses

temporarily relieves:

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 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 
  • if you have ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if

you have asthma

  • stomach bleeding warning applies to you
  • you have a history of stomach problems, such as heartburn
  • you are taking a diuretic
  • 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
  • ringing in the ears or a loss of hearing occurs
  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • new symptoms occur
    These could be signs of a serious condition.

If pregnant or breast-feeding

ask a health professional before use. It is especially important not to use aspirin at 20 weeks or later in 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 PoisonControlCenter right away.

Directions

Other Information

Inactive Ingredients

corn starch

Package/Label Principal Display Panel

Aspirin

Aspirin

ASPIRIN 
aspirin 325 mg tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69168-312
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)  
Product Characteristics
ColorwhiteScoreno score
ShapeROUNDSize11mm
FlavorImprint Code ASPIRIN
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69168-312-01100 in 1 BOTTLE; Type 0: Not a Combination Product12/18/2014
2NDC:69168-312-17300 in 1 BOTTLE; Type 0: Not a Combination Product12/18/2014
3NDC:69168-312-4040 in 1 BOTTLE; Type 0: Not a Combination Product08/23/2023
4NDC:69168-312-98200 in 1 BOTTLE; Type 0: Not a Combination Product08/23/2023
5NDC:69168-312-06120 in 1 BOTTLE; Type 0: Not a Combination Product11/06/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01312/18/2014
Labeler - Allegiant Health (079501930)

Revised: 11/2018
Document Id: 9d8da072-5538-4dfa-91fe-8aa7f3c09010
Set id: 88b54062-8b3d-4024-a957-62b3255184b9
Version: 11
Effective Time: 20181107
 
Allegiant Health