FDA Label for Aerotab Pain Reliever

Drug Facts

Active ingredients (in each caplet)

​Aspirin (NSAID)* 500 mg

Caffeine 32.5 mg

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever

Pain reliever aid

Uses

for the temporary relief of
■ backache pain
■ muscle aches and pains
■ minor aches and 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

■ 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

■ take more or for a longer time than directed

■ take a blood thinning (anticoagulant) or steroid drug

■ are age 60 or older

■ have 3 or more alcohol drinks every day while using this product

■ have had stomach ulcers or bleeding problems

■ take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)

Do Not Use

■ if you are allergic to aspirin or any other pain reliever/fever reducer.
■ 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 asthma

■ you have high blood pressure, heart disease, liver cirrhosis, or kidney disease

■ you are taking a diuretic

Otc - Ask Doctor/Pharmacist

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

■ an allergic reaction occurs. Seek medical help right away.

■ you experience any of the following signs of stomach bleeding: ■ vomit blood ■ have bloody or black stools ■ feel faint ■ have stomach pain that does not get better

■ ringing in the ears or a loss of hearing occurs

■ pain gets worse or lasts more than 10 days

■ fever gets worse or lasts more than 3 days

■ redness or swelling is present

■ new symptoms occur

These could be signs 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 at 20 weeks or later in pregnancy unless specifically 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.

Directions

■ drink a full glass of water with each dose

Adults and children (12 years and over): take 2 caplets every 6 hours, not to exceed 8 caplets in 24 hours

Children under 12 years: do not use unless directed by a doctor

Other Information

■ store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)

■ tamper evident sealed packets

■ do not use any opened or torn packets

Inactive Ingredients

corn starch, hypromellose, maltodextrin, microcrystalline cellulose, polyethylene glycol, sodium lauryl sulfate

Otc - Questions

Questions or comments? 1-845-618-7037
(Monday through Friday 9AM - 5PM EST).

Package Label.Principal Display Panel

AEROTAB

Pain Reliever

Aspirin (NSAID) 500 mg, Caffeine 32.5 mg

Fast Acting Formula

Relieves aches and pains

Contains Caffeine

50 | 2 per packet

(25x2's) - V6.ATPR50US.BX page 0001 min