EXCEDRIN® Back & Body Product Information
Drug Facts
Active ingredients (in each caplet) Purposes
Acetaminophen 250 mg ……………………………………………………………………………………….Pain reliever
Buffered aspirin equal to 250 mg aspirin (NSAID)* ………………………………………………………..Pain reliever
(buffered with calcium carbonate)
*nonsteroidal anti-inflammatory drug
Uses
• for the temporary relief of minor aches and pains due to:
• minor pain of arthritis
• backache
• muscular aches
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 caplets 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 3 or more alcoholic drinks every day while using this product
• 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)
• take more or for a longer time than directed
Do not use
• if you have ever had an allergic reaction to any aspirin or 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
• ulcers
• bleeding problems
• high blood pressure
• heart or kidney disease
• taken a diuretic
• reached age 60 or older
• asthma
• stomach problems that last or come back, such as heartburn, upset stomach, or stomach pain
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 caplets every 6 hours; not more than 8 caplets in 24 hours
• children under 12 years: ask a doctor
Other information
• each caplet contains: calcium 80 mg
• 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 yellow #10 lake, FD&C blue #1 lake, FD&C blue #2 lake, hydroxypropylcellulose, hypromellose, maltodextrin, medium chain triglycerides, microcrystalline cellulose, polydextrose, polysorbate 80, povidone, pregelatinized starch, silicone dioxide, stearic acid, talc, zinc stearate
Questions or comments? 1-800-468-7746
It's important to use Excedrin® Back & Body according to label instructions. As with any medication, if you have any questions, contact your healthcare professional.
