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  5. Label Information: Pharbest Regular Strength Aspirin

FDA Label for Pharbest Regular Strength Aspirin

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT (IN EACH TABLET)
    2. PURPOSE
    3. USES
    4. WARNINGS
    5. DO NOT USE IF
    6. ASK A DOCTOR BEFORE USE IF
    7. ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE TAKING A PRESCRIPTION DRUG FOR:
    8. STOP USE AND ASK A DOCTOR IF:
    9. IF PREGNANT OR BREAST-FEEDING,
    10. KEEP OUT OF REACH OF CHILDREN.
    11. DIRECTIONS
    12. OTHER INFORMATION
    13. INACTIVE INGREDIENTS
    14. QUESTIONS?
    15. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Pharbest Regular Strength Aspirin Product Label

The following document was submitted to the FDA by the labeler of this product Pharbest Pharmaceuticals, Inc. 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/ fever reducer


Uses



temporarily relieves

  • headache
  • muscle pain
  • toothache
  • menstrual pain
  • pain and fever of colds
  • minor pains of arthritis

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
  • asthma (wheezing)
  • facial swelling
  • 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 are allergic to aspirin or any other pain reliever/fever reducer


Ask A Doctor Before Use If



  • the 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 have asthma
  • you are taking a diuretic

Ask A Doctor Or Pharmacist Before Use If You Are Taking A Prescription Drug For:



  • gout
  • diabetes
  • 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
  • allergic reaction occurs
  • pain gets worse or lasts more than 10 days
  • redness or swelling is present
  • any new symptoms occur
  • ringing in the ears or loss of hearing occurs
  • fever lasts more than 3 days

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 accidental overdose, get medical help or contact a Poison Control Center right away.


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. Do not exceed 12 tablets in 24 hours
     children 6 to under 12 years consult a physician


Other Information



  • store at 20°-25°C (68°-77°F)
  • avoid excess heat and moisture

Inactive Ingredients



Corn starch


Questions?



Adverse drug event call: (866) 562-2756 (Mon- Fri 8 AM-5PM EST)


Package Label.Principal Display Panel



Manufactured in the U.S.A

Pharbest

Regular Strength

*Compare to active ingredient in Genuine Bayer® Aspirin

Aspirin

Pain Reliever • Fever Reducer (NSAID)

Aspirin, 325 mg each


* Please review the disclaimer below.