FDA Label for Pharbest Aspirin 325mg

View Indications, Usage & Precautions

Pharbest Aspirin 325mg Product Label

The following document was submitted to the FDA by the labeler of this product Contract Pharmacy Services-pa. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Active Ingredient (In Each Tablet)



Aspirin 325mg (NSAID)*

*nonsteroidal anti-inflammatory drug


Purpose



Pain reliever


Uses



  • temporarily relieves minor aches and pains due to • colds • headache • muscle pain • menstrual pain • minor pains of arthritis • toothache
  • or as receommended by your doctor

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 a nonsteroidal anti-inflammatory drug (NSAID), which may cause severe stomach bleeding. The chance is higher if you

    • are age 60 or older
    • take a blood thinning (anticoagulant) or steroid drug
    • take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
    • take more or for a longer time than directed
    • have had stomach ulcers or bleeding problems
    • have 3 or more alcoholic drinks every day while using this product

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 while symptoms persist. Do not exceed 12 tablets in 24 hours unless diretced by a physician. 
     children under 12 years consult a physician


Other Information



  • avoid excess heat and moisture
  • store below 25 0 C (77 0 F)

Inactive Ingredients



croscarmellose sodium, D&C yellow #10 Lake, FD&C red #6, hypromellose, methacrylic acid copolymer, microcrystalline cellulose, polyethylene glycol, propylene glycol, sodium lauryl sulfate, starch, stearic acid, talc, titanium dioxide, triacetin. 


Questions Or Comments?



Adverse drug event call: 1-866-562-2756 


Package Label.Principal Display Panel



Manufactured in the U.S.A

PHARBEST

Aspirin Regimen 

Compare to the active ingredient in Ecotrin ® Regular Strength

#1 Choise of Cardiologists

Aspirin 325mg

Regular Strength

Safety Coated Aspirin 325mg

PAIN RELIEVER (NSAID)

NOT FOR HOUSEHOLDS WITH YOUNG CHILDREN


* Please review the disclaimer below.