Extra Strength Headache Relief
WOONSOCKET PRESCRIPTION CENTER,INCORPORATED
FULL PRESCRIBING INFORMATION: CONTENTS*
- Active ingredients (in each caplet)
- Extra Strength Headache Relief Uses
- Extra Strength Headache Relief Other information
- Inactive ingredients
- Questions or comments?
- Principal Display Panel
FULL PRESCRIBING INFORMATION
Active ingredients (in each caplet)
Acetaminophen 250 mg
Aspirin 250 mg (NSAID)*
Caffeine 65 mg
*nonsteroidal anti-inflammatory drug
Pain reliever aid
Extra Strength Headache Relief Uses
- temporarily relieves minor aches and pains due to:
- a cold
- muscular aches
- premenstrual and mesntrual cramps
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:
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
you have a history of stomach problems, such as heartburn
stomach bleeding warning applies to you
you have asthma
you have high blood pressure, heart disease, liver cirrhosis or kidney disease
you are taking a diuretic
Ask a doctor or pharmacist before use if you are
taking a prescription drug for diabetes, gout, or arthritis
taking any other drug or are under a doctor’s care for any serious condition
Stop use and ask a doctor if
you experience any of the following signs of stomach bleeding:
have bloody or black stools
have stomach pain that does not get better
an allergic reaction occurs. Seek medical help right away.
any new symptoms appear
ringing in the ears or loss of hearing occurs
pain gets worse or lasts for more than 10 days
fever gets worse or lasts for more than 3 days
painful area is red or swollen
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 (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
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
Extra Strength Headache Relief Other information
- store at 25ºC (77ºF); excursions permitted between 15°-30°C (59°-86°F)
- see end flap for expiration date and lot number
corn starch, crospovidone, hypromellose, microcrystalline cellulose, povidone, propylene glycol, sodium lauryl sulfate, sodium starch glycolate, stearic acid, titanium dioxide
Questions or comments?
Principal Display Panel
Compare to the active ingredients in Excedrin® Extra Strength†
ACETAMINOPHEN, ASPIRIN (NSAID)
PAIN RELEIVER AID
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
†This product is not manufactured or distributed by Novartis Consumer Health, owner of the registered trademark Excedrin® Extra Strength.
Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
© 2014 CVS/pharmacy
CVS.com® 1-800-SHOP CVS
Extra Strength Headache Relief
Acetaminophen, Aspirin and Caffeine TABLET, FILM COATED