FDA Label for Careall Aspirin

Active Ingredient

Aspirin 81mg (NSAID*)

*nonsteroidal anti-inflammatory drug

Purpose

Pain Reliever

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 immediately. 1-800-222-1222

Uses

For the temporary relief of minor aches and pain 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.

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 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 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 relievers / fever reducers

If you have ever had an allergic reaction to this product or any of its ingredients

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.

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 of age: consult a doctor

Inactive Ingredients

colloidal silicon dioxide, corn starch, crospovidone, D C yellow 10 aluminum lake, FD C yellow 6 aluminum lake, hypromellose, methacrylic acid copolymer, microcrystalline cellulose, stearic acid, talc, titanium dioxide, triethyl ceitrate