ASPIRIN LOW DOSE CHEWABLE- aspirin tablet, chewable 
Contract Pharmacy Services-PA

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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Aspirin Low Dose Chewable Tablets

DRUG FACTS

ACTIVE INGREDIENT (IN EACH TABLET)

Aspirin 81 mg (NSAID*)

*nonsteroidal anti-inflammatory drug

PURPOSE

Pain reliever

USES

Temporarily relieves minor aches and pains
for other uses, see your doctor, but do not use for more
than 10 days without consulting your doctor because
serious side effects may occur

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 a nonsteroidal anti-inflammatory drug (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

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

Ask a doctor or pharmacist before use if

taking a prescription drug for diabetes, gout or arthritis

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
  • pain gets worse or lasts for more than 10 days
  • redness or swelling is present
  • any new symptoms appear
  • 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 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.

Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

DIRECTIONS

OTHER INFORMATION

store at 20° to 25°C (68° to 77°F)

QUESTIONS OR COMMENTS?

Manufactured by:

Pharbest Pharmaceuticals

14 Engineers Lane

Farmingdale, L.I., New York

call toll free 631-249-5133

Repackaged by:

Contract Pharmacy Services-PA
125 Titus Ave Suite 200
Warrington, PA 18976 USA

Original--08/2010--NJW

Package Label

Blister of 30 Tablets

Blister of 30 Tablets

ASPIRIN LOW DOSE CHEWABLE 
aspirin tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67046-165(NDC:16103-366)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN81 mg
Product Characteristics
ColorORANGEScoreno score
ShapeROUNDSize8mm
FlavorImprint Code PH;034
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67046-165-3030 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34308/09/2010
Labeler - Contract Pharmacy Services-PA (945429777)

Revised: 7/2010
Document Id: 390334bc-5c58-4c43-8d1c-6a9dc017891b
Set id: 390334bc-5c58-4c43-8d1c-6a9dc017891b
Version: 1
Effective Time: 20100730
 
Contract Pharmacy Services-PA