Direct Safety Aspirin

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each tablet)

Aspirin 325 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

OTC - PURPOSE SECTION

Purpose

Pain reliever/fever reducer

INDICATIONS & USAGE SECTION

Uses

temporarily relieves

■ headache

■ muscle pain

■ toothache

■ menstrual pain

■ pain and fever of colds

■ minor pain of arthritis

WARNINGS SECTION

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

■ facial swelling

■ asthma (wheezing)

■ shock

If an allergic reaction occurs, stop use and seek medical help right away.

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 alcohol drinks every day while using this product

■ take more or for a longer time than directed

OTC - DO NOT USE SECTION

Do not use if you are allergic to aspirin or to any other pain reliever/fever reducer

OTC - ASK DOCTOR SECTION

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 are taking a diuretic

■ you have asthma

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are taking a prescription drug for

■ gout

■ diabetes

■ arthritis

OTC - STOP USE SECTION

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

■ pain gets worse or lasts more than 10 days

■ fever lasts more than 3 days

■ if ringing in the ears or loss of hearing occurs

■ redness or swelling is present

■ new symptoms occur

OTC - PREGNANCY OR BREAST FEEDING SECTION

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 SECTION

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

Directions

■ drink a full glass of water with each dose

Adults and children 12 years and over: take 1 or 2 tablets every 4 hours or 3 tablets every 6 hours, not to exceed 12 tablets in 24 hours

Children under 12 years: consult a doctor

OTHER SAFETY INFORMATION

Other information

■ store at room temperature

■ avoid excessive heat and humidity

■ tamper evident sealed packets

■ do not use any opened or torn packets

INACTIVE INGREDIENT SECTION

I nactive ingredients

corn starch, hypromellose*, microcrystalline cellulose*, polyethylene glycol* povidone*, propylene glycol*

* may contain

OTC - QUESTIONS SECTION

Questions or comments? 1-800-356-9100

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Direct Safety®

Aspirin

Pain Reliever

Aspirin 325 mg (NSAID)

Aspirina 325 mg (AINE)

This Package is for Households without Young Children.

Este Paquete Es Hogares Sin Ninos Pequenos

Industrial Pack 500

(250 Packets of 2 Tablets)