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  5. Label Information: Pain Reliever

FDA Label for Pain Reliever

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. OTC - PURPOSE
    3. USES
    4. REYE'S SYNDROME
    5. ALLERGY ALERT
    6. STOMACH BLEEDING WARNING
    7. DO NOT USE
    8. ASK A DOCTOR BEFORE USE IF
    9. ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
    10. STOP USE AND ASK A DOCTOR IF
    11. OTC - PREGNANCY OR BREAST FEEDING
    12. OTC - KEEP OUT OF REACH OF CHILDREN
    13. DIRECTIONS
    14. OTHER INFORMATION
    15. INACTIVE INGREDIENTS
    16. QUESTIONS OR COMMENTS?
    17. PRINCIPAL DISPLAY PANEL

Pain Reliever Product Label

The following document was submitted to the FDA by the labeler of this product Healthlife Of Usa. 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.

Other



Drug Facts


Otc - Purpose



Active Ingredients (in each tablet)                          Purpose

Aspirin 81 mg (NSAID)* ........................................ Pain reliever

*nonsteroidal anti-inflammatory drug


Uses



  • temporary relief of minor aches and pains or as recommended by your doctor. Because of its delayed action, this product will not provide fast relief of headaches or other symptoms needing immediate relief.
  • ask your doctor about other uses for 81 mg Aspirin

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
  • shock
  • facial swelling
  • asthma (wheezing)

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



  • you have asthma
  • 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 You Are



  • taking a prescription drug for diabetes, gout, or arthritis
  • under a doctor's care for any serious condition
  • taking any other drug

Stop Use And Ask A Doctor If



  • you experience any of the following signs of stomach bleeding:
  • feel faint
  • have bloody or black stools
  • vomit blood
  • have stomach pain that does not get better
  • an allergic reaction occurs.

    •    Seek medical help right away.

    • ringing in the ears or loss of hearing occurs
    • pain gets worse or lasts for more than 10 days
    • fever gets worse or lasts for more than 3 days
    • redness or swelling present in the painful area
    • new symptoms occur

      • These could be sign of a serious condition


Otc - Pregnancy Or Breast Feeding



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.


Otc - Keep Out Of Reach Of Children



Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.


Directions



  • drink a full glass of water with each dose
  • adults and children 12 years and over: take 4 to 8 tablets every 4 hours; not to exceed 48 tablets in 24 hours unless directed by a doctor
  • children under 12 years: consult a doctor

Other Information



  • store at room temperature 15-30°C (59-86°F)
  • read all product information before using.
  • Keep this box for important information

  • TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING


Inactive Ingredients



Anhydrous Lactose, Carnuba Wax Colloidal Sillicon Dioxide, Crosscarmellose Sodium,FD&C Yellow #10 al lake, FD&C Yellow#6 al Lake, Iron Oxide Ochre, Methacrylic acid copolymer, Micro crystalline cellulose, Polysorbate 80, simethiocone, sodium hydroxide, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate


Questions Or Comments?



Call toll free 1-844-832-1138 Monday through Friday 9AM – 5PM EST or www.healthlifeofusa.com


Principal Display Panel



See New Warnings Information & Directions

Compare to Bayer® Low Dose Aspirin active ingredients†

† This product is not manufactured or distributed by Bayer HealthCare LLC., owner of the registered trademark Bayer® Low Dose Aspirin.

Aspirin Delayed Release Tablets, 81 mg

Principal Display Panel - Aspirin

Principal Display Panel - Aspirin


* Please review the disclaimer below.