ASPIRIN  - aspirin  tablet, coated 
New World Imports, Inc

DRUG FACTS

Aspirin 81mg (NSAID*)

*nonsteroidal anti-inflammatory drug

Pain Reliever

Keep out of reach of Children.  In case of overdose, get medical help or contact a Poison Control Center immediately.

For the 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.

Rene'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 with may included hives, facial swelling, asthma (wheezing) and shock

Stomach Bleeding Warning: this product containers 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 2 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 relievers / fever reducers

Ask a doctor before use if:
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 have taken a diuretic

Ask a doctor or pharmacist before use if you are taking a prescription drug for anticoagulation (thinning of the blood), diabetes, gout, arthritis

Stop use and ask a doctor if:
An allergic reaction occurs.  Seek medical help right away
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
New symptoms occur
Redness or swelling is present
Ringing in the ears or loss of hearing occurs
Pain gets worse or lasts more than 10 days
You may report serious side effects to 1-888-952-0050

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 specifically directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery. 

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

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ASPIRIN  aspirin  tablet, coated

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 51824-547 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Aspirin (Aspirin) Aspirin 81 mg

Inactive Ingredients Ingredient Name Strength Anhydrous lactose   CARNAUBA WAX   SILICON DIOXIDE   Croscarmellose Sodium   D&C YELLOW NO. 10   Iron   Methacrylic Acid   CELLULOSE, MICROCRYSTALLINE   Polysorbate 80   Dimethicone   Silicon Dioxide   Sodium Hydroxide   Sodium Lauryl Sulfate   Titanium Dioxide   Triethyl Citrate

Product Characteristics Color yellow (yellow) Score no score Shape ROUND (round) Size 8mm Flavor Imprint Code A Contains

Packaging # NDC Package Description Multilevel Packaging 1 51824-547-01 120 TABLET In 1 BOTTLE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part343	01/25/2011

Labeler - New World Imports, Inc (075372276)

Revised: 01/2011New World Imports, Inc