EXTRA STRENGTH HEADACHE RELIEF- acetaminophen, aspirin, and caffeine capsule
Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
|Active ingredients (in each softgel)||Purposes
|Acetaminophen 250 mg||Pain reliever
|Aspirin 250 mg (NSAID)
|Caffeine 65 mg||Pain reliever aid
temporarily relieves minor aches and pains due to:
- a cold
- muscular aches
- premenstrual & menstrual cramps
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.
Acetaminophen may cause severe skin reactions. Symptoms may include:
- skin reddening
If a skin reaction occurs, stop use and seek medical help right away.
Aspirin may cause a severe allergic reaction which may include:
- facial swelling
- asthma (wheezing)
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
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 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 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, or arthritis
- any other drug, or are under a doctor's care for any serious condition
Stop use and ask 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
- 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 occur
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. 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 softgels every 6 hours; not more than 8 softgels in 24 hours
- children under 12 years: ask a doctor
- store at 20° - 25° C (68° - 77° F)
- close cap tightly after use
- read all product information before using.
Beeswax, carboxymethyl cellulose, D&C Yellow No.10, ethanol, FD&C Blue No.1, gelatin, glycerin, HPMC, light liquid paraffin, PEG 400, purified water, shellac, sorbitol sorbitan solution, soya bean oil, soya lecithin, stearic acid, titanium dioxide
Questions or comments
DISTRIBUTED BY: WALGREEN CO., 200 WILMOT RD., DEERFIELD, IL 60015
PRINCIPAL DISPLAY PANEL - 80 Softgel Bottle Label
Caffeine / Pain Reliever /
Pain Reliever Aid
Compare to Excedrin
® Extra Strength active ingredients