EXTRA STRENGTH HEADACHE- acetaminophen/aspirin/caffeine tablet tablet
Lil' Drug Store Products, Inc.
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.
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Active ingredients (in each caplet)
Acetaminophen 250 mg
Aspirin 250 mg (NSAID)*
Caffeine 65 mg
*nonsteroidal anti-inflammatory drug
Purposes
Pain reliever
Pain reliever
Pain reliever aid
Uses
- temporarily relieves minor aches and pains due to:
- headache
- a cold
- arthritis
- muscular aches
- sinusitis
- toothache
- premenstrual and menstrual cramps
Reye's Syndrome
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
Allergy alert:Aspirin may cause a severe allergic reaction,
which may include:
- hives
- facial swelling
- asthma (wheezing)
- shock
Allergy Alert
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
- skin reddening
- blisters
- rash
If a skin reaction occurs, stop use and seek medical help right away.
Liver Warning
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
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
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
Ask a doctor or pharmacist before use if you are taking
- any other drug containing an NSAID (prescription or nonprescription)
- a prescription drug for diabetes, gout, or arthritis
- any other drug or are under a doctor’s care for any serious condition
- a blood thinning (anticoagulant) or steroid drug
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
- 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
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.
Overdose warning
Overdose warning: 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 Overdose warning)
- 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: ask a doctor
Other information
- store between 20°-25°C (68°-77°F)
Inactive ingredients
colloidal silicon dioxide, hypromellose, microcrystalline cellulose, polyethylene glycol, povidone K30, pregelatinized starch, stearic acid, talc
Questions or comments?
Call toll-free
1-877-507-6516 (M-F 8AM-4:30PM CST)
PDP
[caduceus]
Compare to the Active
Ingredients in Excedrin®
Extra Strength**
Extra Strength
Headache
Acetaminophen 250 mg
Pain Reliever
Aspirin (NSAID) 250 mg Pain Reliever
Caffeine 65 mg Pain Reliever Aid
[caplets image]
ACTUAL SIZE
50
Caplets [Lil' Drug Store Logo]
Lil' Drug Store Products, Inc.