Circle K ™ Headache Relief Extra Strength

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - PURPOSE SECTION

Uses

• temporarily relieves minor aches and pains due to: headachea coldarthritismuscular achestoothachepremenstrual and menstrual cramps

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

Acetaminophen may cause severe skin reactions. Symptoms may include:

If a skin reaction occurs, stop use and seek medical help right away.

• skin reddening
• blisters
• rash

Allergy alert

Aspirin may cause a severe allergic reaction, which may include:

• hives
• facial swelling
• asthma (wheezing)
• shock

Liver warning

This product contains acetaminophen. Severe liver damage may occur if you take:

• more than 8 caplets in 24 hours, which is the maximum daily amount
• with other drugs containing acetaminophen
• 3 or more alcoholic drinks every day while using this product

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

Caffeine warning

The recommended dose of this product contains about as much caffeine as a cup of coffee. Limit the use of caffeine-containing medications, foods, or beverages while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness, and, occasionally, rapid heartbeat.

Do not use

• if you have ever had an allergic reaction to acetaminophen, aspirin or any other pain reliever/fever reducer
• with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

Ask a doctor before use if

• you have liver disease
• 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 diabetes, gout, or arthritis
• any other drug or are under a doctor's care for any serious condition

Stop use and ask a doctor if

These could be signs of a serious condition.

• an allergic reaction occurs. Seek medical help right away.
• you experience any of the following signs of stomach bleeding feel faintvomit bloodhave bloody or black stoolshave stomach pain that does not get better.
• ringing in the ears or loss of hearing occurs
• painful area is red or swollen
• pain gets worse or lasts for more than 10 days
• fever gets worse or lasts for more than 3 days
• any new symptoms appear

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. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

• do not use more than directed
• drink a full glass of water with each dose
• adults and children 12 years and over: take 2 caplets every 6 hours; do not take more than 8 caplets in 24 hours
• children under 12 years: do not use unless directed by a doctor

Other information

• store between 20°-25°C (68°-77°F)

Inactive ingredients

carnauba wax contains one or more of these ingredients, colloidal silicon dioxide, corn starch, hypromellose, microcrystalline cellulose, mineral oil , polyethylene glycol , povidone, sodium starch glycolate , stearic acid, talc , titanium dioxide

SPL UNCLASSIFIED SECTION

Proudly distributed by Circle K Stores Inc.