ASPIRIN- aspirin tablet, chewable 
Publix Super Markets Inc

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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Active ingredient (in each tablet)

Aspirin 81 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever

Uses

  • for the temporary relief of minor aches and pains

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
  • for at least 7 days after tonsillectomy or oral surgery unless directed by a doctor

Ask a doctor before use if

  • you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
  • stomach bleeding warning applies to you
  • you have a history of stomach problems, such as heartburn
  • 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 or 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 for more than 10 days
  • redness or swelling is present
  • new symptoms appear
  • ringing in the ears or a loss of hearing occurs

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 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 4 to 8 tablets every 4 hours not to exceed 48 tablets in 24 hours unless directed by a doctor
  • children under 12 years: ask a doctor

Other information

  • store at 20°-25°C (68°-77°F)

Inactive ingredients

dextrose excipient, FD&C yellow no. 6 lake, flavors, saccharin sodium, starch

Principal Display Panel

LOW DOSE

chewable aspirin

ASPIRIN REGIMEN

81 mg

RAIN RELIEVER (NSAID)

orange flavor

SEE NEW WARNINGS INFORMATION

Compare to the active ingredient in Bayer® Chewable Aspirin

Chewable Aspirin Carton Image 1

Chewable Aspirin Carton Image 1

Chewable Aspirin Carton Image 2

Chewable Aspirin Carton Image 2

ASPIRIN 
aspirin tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:56062-467
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASPIRIN (ASPIRIN) ASPIRIN81 mg
Inactive Ingredients
Ingredient NameStrength
SACCHARIN SODIUM 
Product Characteristics
ColorORANGEScoreno score
ShapeROUNDSize8mm
FlavorORANGEImprint Code L467
Contains    
Packaging
#Item CodePackage Description
1NDC:56062-467-681 in 1 CARTON
136 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34307/02/1999
Labeler - Publix Super Markets Inc (006922009)

Revised: 04/2010
Document Id: c51dae48-aa49-4926-b04a-0da264e08dfa
Set id: c51dae48-aa49-4926-b04a-0da264e08dfa
Version: 1
Effective Time: 20100429
 
Publix Super Markets Inc