Active ingredients (in each GelTab)
Acetaminophen 250 mg
Aspirin 250 mg (NSAID)*
Caffeine 65 mg
*nonsteroidal anti-inflammatory drug
Uses
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- temporarily relieves minor aches and pains due to:
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- headache
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- a cold
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- arthritis
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- muscular aches
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- toothache
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- 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: 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.
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 geltabs 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 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 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
- •
- 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 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.
Directions
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- do not use more than directed
- •
- drink a full glass of water with each dose
- •
- adults and children 12 years and over: take 2 geltabs every 6 hours; not more than 8 geltabs in 24 hours
- •
- children under 12 years: ask a doctor
Other information
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- store at 20°-25°C (68°-77°F)
- •
- close cap tightly after use
- •
- read all product information before using. Keep this box for important information.
Inactive ingredients
benzoic acid, D&C yellow #10 aluminum lake, edetate disodium, FD&C blue #1, FD&C blue #1 aluminum lake, FD&C red #40 aluminum lake, gelatin, glycerin, hypromellose, iron oxide black, isopropyl alcohol, lactose monohydrate, light mineral oil, low-substituted hydroxypropyl cellulose, maltitol syrup, medium-chain triglycerides, microcrystalline cellulose, pepsin, polysorbate 20, povidone, propyl gallate, propylene glycol, simethicone, sorbitan monolaurate, stearic acid, titanium dioxide
Principal Display Panel
NDC 0067-2021-20
EXCEDRIN
EXTRA STRENGTH
Acetaminophen, Aspirin (NSAID) and Caffeine
Pain Reliever/Pain Reliever Aid
20 GELTABS
TAMPER-EVIDENT BOTTLE
DO NOT USE IF INNER FOIL SELA IMPRINTED WITH “SEALED for YOUR PROTECTION” IS BROKEN OR MISSING
Distributed by: GSK Consumer Healthcare
Warren, NJ 07059
©2015 GSK or its licensor.
Visit us at www.excedrin.com
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