Extra Strength Headache Relief
WOONSOCKET PRESCRIPTION CENTER,INCORPORATED
FULL PRESCRIBING INFORMATION: CONTENTS*
- Active ingredients (in each gelcap)
- 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 gelcap)
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 menstrual cramps
Reye's syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use 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:
- facial swelling
- asthma (wheezing)
Liver 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
- have 3 or more alcoholic drinks every day while using this product
- take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]
- 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, occassionally, rapid heartbeat.
Do not use
- if you ever had an allergic reaction to 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 have asthma
- 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:
- feel faint
- have bloody or black stools
- vomit blood
- 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 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 gelcaps every 6 hours
- do not take more than 8 gelcaps in 24 hours
- children under 12 years: do not use unless directed by a doctor
Extra Strength Headache Relief Other information
- store at controlled room temperature 15º-30ºC (59º-86ºF)
- see end flap for expiration date and lot number
corn starch, D&C yellow #10, FD&C blue #1, FD&C yellow #6, gelatin, hydroxypropyl cellulose, hypromellose, microcyrstalline cellulose, polyethylene glycol, povidone, pregelatinized starch, propylene glycol, shellac glaze, simethicone, 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 Express Gels™
RAPID RELEASE GELCAPS
ASPIRIN (NSAID) AND CAFFEINE
Pain reliever aid
FAST RELEASE GELS
†This product is not manufactured or distributed by Novartis Consumer Health Inc., owner of the registered trademark Excedrin® Extra Strength Express Gels.
Distributed by: CVS/pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
Extra Strength Headache Relief
Acetaminophen, Aspirin, Caffeine CAPSULE, GELATIN COATED