ASPIRIN - aspirin tablet, chewable 
Physicians Total Care, 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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Perrigo Aspirin Drug Facts

Active ingredient (in each tablet)

Aspirin 81 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever

Uses

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 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

Other information

Inactive ingredients

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

Questions or comments?

1-800-719-9260

Principal Display Panel

Chewable

See New Warnings Information

Aspirin 81 mg

Pain Reliever (NSAID)

Orange Flavor

Low Dose

Aspirin Regimen

NDC 54868-4864-0

Aspirin Carton



Distributed by:
L Perrigo Company
Allegan, MI    49010


Additional barcode labeling by:
Physicians Total Care, Inc.
Tulsa, Oklahoma      74146

ASPIRIN 
aspirin tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54868-4864(NDC:0113-0467)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN81 mg
Inactive Ingredients
Ingredient NameStrength
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
DEXTROSE (UNII: IY9XDZ35W2)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
Product Characteristics
ColorORANGEScoreno score
ShapeROUNDSize8mm
FlavorORANGEImprint Code L467
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54868-4864-01 in 1 CARTON
136 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34311/01/2007
Labeler - Physicians Total Care, Inc. (194123980)
Establishment
NameAddressID/FEIBusiness Operations
Physicians Total Care, Inc.194123980relabel

Revised: 2/2012
Document Id: 790831a1-b88b-4279-b34c-4d76dd20a266
Set id: 6ef93883-10b9-4742-ad27-b9327be5dee6
Version: 1
Effective Time: 20120221
 
Physicians Total Care, Inc.