Extra Strength Excedrin® Express Gels® Product Information

Drug Facts


Active ingredients (in each gelcap) Purposes
Acetaminophen 250 mg ………………………………………………………………………………………..Pain reliever
Aspirin 250 mg (NSAID)* …………………………………………………………………………………….....Pain reliever

Caffeine 65 mg ……………………………………………………………………………………………...Pain reliever aid
*nonsteroidal anti-inflammatory drug


Uses

• temporarily relieves minor aches and pains due to:
    • headache      • a cold            • arthritis         • muscular aches
    • sinusitis         • toothache     • premenstrual & 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 gelcaps in 24 hours
• with other drugs containing acetaminophen
• 3 or more alcoholic drinks every day while using this product

Stomach bleeding warning: This product contains a nonsteroidal anti-inflammatory drug (NSAID), which may cause 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 an NSAID (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 heart beat.


Do not use
• if you have ever had an allergic reaction to aspirin or any other pain reliever/fever reducer
• with any other drug containing acetaminophen (prescription or nonprescription). Ask a doctor or pharmacist before using with other drugs if you are not sure.


Ask a doctor before use if you have
• liver disease
• stomach problems that last or come back, such as heartburn, upset stomach, or stomach pain
• ulcers
• bleeding problems
• high blood pressure
• heart or kidney disease
• taken a diuretic
• reached age 60 or older
• asthma


Ask a doctor or pharmacist before use if you are taking:
• any other drug containing an NSAID (prescription or nonprescription)
• a blood thinning (anticoagulant) or steroid drug
• 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 a doctor if
• an allergic reaction occurs. Seek medical help right away.
• you feel faint, vomit blood, or have bloody or black stools. These are signs of stomach bleeding.
• stomach pain or upset gets worse or lasts
• 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
• any new symptoms appear


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.


Directions

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; not more than 8 gelcaps in 24 hours
• children under 12 years: ask a doctor


Other information

• store at controlled room temperature 20°-25°C (68°-77°F)
• read all product information before using. Keep this box for important information.


Inactive ingredients

benzoic acid, D&C red # 28, D&C yellow #10, FD&C green #3, gelatin, hydroxypropyl cellulose, hypromellose, light mineral oil, microcrystalline cellulose, pepsin, polysorbate 20, povidone, propylene glycol, simethicone emulsion, sorbitan monolaurate, stearic acid, titanium dioxide


Questions or comments? 1-800-468-7746

It's important to use Extra Strength Excedrin® Express Gels® according to label instructions. As with any medication, if you have any questions, contact your healthcare professional.


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