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  5. Label Information: Low Dose Aspirin Chewable

FDA Label for Low Dose Aspirin Chewable

View Indications, Usage & Precautions

Table of Contents

    1. DRUG FACTS
    2. PURPOSE
    3. USES
    4. WARNINGS
    5. ALLERGY ALERT
    6. STOMACH BLEEDING WARNING
    7. IF PREGNANT OR BREAST-FEEDING
    8. KEEP OUT OF REACH OF CHILDREN
    9. DIRECTIONS
    10. OTHER INFORMATION
    11. INACTIVE INGREDIENTS
    12. PRINCIPAL DISPLAY PANEL

Low Dose Aspirin Chewable 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.

Drug Facts



Active Ingredient (in each Tablet)

Aspirin 81mg (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 behaviour 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:

  • facial swelling
  • hives
  • shock
  • 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

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 overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.


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



  • TAMPER EVIDENT: DO NOT USE THIS PRODUCT IF THE IMPRINTED FOIL SEAL OVER THE MOUTH OF THE BOTTLE IS CUT, TORN, BROKEN OR MISSING
  • store at 25°C (77°F); excursion permitted between 15°-30°C (59°-86°F)
  • use by expiration date on package

Inactive Ingredients



  • Butylated Hydroxytoluene
  • Dextrates
  • FD&C Yellow No.6
  • Cellulose, Microcrystalline
  • Corn Starch
  • Orange
  • Modified corn starch
  • Saccharin soidum 
  • Stearic acid 

Principal Display Panel



Low Dose

ASPIRIN 81mg

30 Chewable Tablets 


* Please review the disclaimer below.