EXCEDRIN EXTRA STRENGTH
-
acetaminophen,
aspirin and
caffeine tablet, film coated
Novartis Consumer Health, Inc.
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DRUG FACTSActive ingredient (in each tablet)
Acetaminophen 250 mg
Aspirin 250 mg (NSAID)*
Caffeine 65 mg
*nonsteroidal anti-inflammatory drug
Purpose
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 & 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 tables 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 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). 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
- high blood pressure
- you have asthma
Ask a doctor or pharmacist before use
- 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 doctor if
- an allergic reaction occurs. Seek medical help right away.
- you experience any of the following signs os 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
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
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 (see Overdose Warning)
- drink a full glass of water with each dose
- adults and children 12 years and over: take 2 tablets every 6 hours; not more than 8 tables in 24 hours
- children under 12 years: ask a doctor
Other information
- store at controlled room temperature 200 - 250 C (680 - 770 F)
- read all product information before using. Keep this box for important information
Inactive ingredients
benzoic acid, carnauba wax, FD&C blue #1, hydroxypropylcellulose, hypromellose, light mineral oil, microcrystalline cellulose, polysorbate 20, povidone, propylene glycol, simethicone emulsion, sorbitan monolaurate, stearic acid, titanium dioxide
Principal Display Panel
| EXCEDRIN
EXTRA STRENGTH
acetaminophen, aspirin (nsaid), and caffeine tablet, film coated |
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| OTC monograph final | part343 | 09/27/2006 | |
| Labeler - Novartis Consumer Health, Inc. (879821635) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| Novartis Consumer Health | 129836151 | MANUFACTURE, ANALYSIS | |