Pharbest Aspirin 325mg
FDA Label NDC 67046-169

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Contract Pharmacy Services-pa for the product Pharbest Aspirin 325mg (NDC 67046-169). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient (in each tablet), purpose, uses, warnings, do not use, ask a doctor before use if, ask a doctor or pharmacist before use if you are, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

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

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