headache relief

Publix Super Markets Inc

Publix Super Markets, Inc. Headache Relief Drug Facts

FULL PRESCRIBING INFORMATION: CONTENTS*

• Active ingredient (in each tablet)
• Purpose
• headache relief Uses
• Warnings
  • When using this product
  • Do not use
  • Ask a doctor before use if
  • Ask a doctor or pharmacist before use if you are
  • Stop use and ask a doctor if
  • If pregnant or breast-feeding,
  • Keep out of reach of children.
• Directions
• headache relief Other information
• Inactive ingredients
• Principal Display Panel

FULL PRESCRIBING INFORMATION

Active ingredient (in each tablet)

Acetaminophen 250 mg

Aspirin 250 mg (NSAID)*

Caffeine 65 mg

*nonsteriodal anti-inflammatory drug

Purpose

Pain reliever

Pain reliever aid

headache relief Uses

• temporarily relieves minor aches and pains due to:
• headache
• muscular aches
• sinusitis
• arthritis
• a cold
• toothache
• premenstrual 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: 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 tablets 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

When using this product

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 heart beat.

Do not use

• if you have ever had an allergic reaction to any other pain reliever/fever reducer
• if you are allergic to aspirin
• 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

Ask a doctor or pharmacist before use if you are

taking a prescription drug for

• 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
• redness or swelling is present
• any new symptoms occur
• pain gets worse or lasts more than 10 days
• fever gets worse or lasts more than 3 days
• ringing in the ears or a loss of hearing occurs

These could be signs of a serious condition

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.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) 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 (see Liver warning)
• drink a full glass of water with each dose
• adults and children 12 years and over: take 2 tablets every 6 hours; do not exceed 8 tablets in 24 hours
• children under 12 years: ask a doctor

headache relief Other information

store at 20º-25ºC (68º-77ºF)

Inactive ingredients

carnauba wax, crospovidone, FD&C blue no. 1 lake, hypromellose, microcrystalline cellulose**, povidone, propylene glycol, saccharin sodium, starch, stearic acid, titanium dioxide **may contain this ingredient

Principal Display Panel

SEE NEW WARNINGS INFORMATION

ADDED STRENGTH

headache relief

ACETAMINOPHEN, ASPIRIN (NSAID) & CAFFEINE

PAIN RELIEVER/PAIN RELIEVER AID

headaches

muscle aches

menstrual pain

minor arthritis pain

ACTUAL SIZE

Compare to the Active Ingredients in Excedrin® Extra Strength Tablets