EXCEDRIN BACK AND BODY- acetaminophen, aspirin tablet, film coated
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
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
Buffered aspirin equal to 250 mg aspirin (NSAID)*
(buffered with calcium carbonate)
*nonsteroidal anti-inflammatory drug
Purposes
Pain reliever
Pain reliever
Uses
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- for the temporary relief of minor aches and pains due to:
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- minor pain of arthritis
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- backache
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- 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)
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- shock
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
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- 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
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 blood thinning (anticoagulant) or steroid drug
- •
- a prescription drug for diabetes, gout, or arthiritis
- •
- 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
- o
- feel faint
- o
- vomit blood
- o
- hoave bloody or black stools
- o
- have stomach pain that does not get better
- •
- ringing in the ears or loss of hearing occurs
- •
- painful area is red or swollen
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- 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.
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
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-
do not use more than directed
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- drink a full glass of water with each dose
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- adults and children 12 years and over: take 2 caplets every 6 hours; not more than 8 caplets in 24 hours
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- children under 12 years: ask a doctor
Other information
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-
each caplet contains: calcium 80 mg
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- store at controlled room temperature 20°-25°C (68°-77°F)
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- 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
Principal Display Panel
NDC 0067-6238-24
EXCEDRIN
BACK & BODY
EXTRA STRENGTH
Acetaminophen and Buffered Aspirin (NSAID)
Pain Reliever
See new warnings information
24 BI-LAYER CAPLETS
TAMPER-EVIDENT BOTTLE
DO NOT USE IF INNER FOIL SEAL IMPRINTED WITH “SELAED for YOUR PROTECTION” IS BROKEN OR MISSING
Distributed by: Novartis Consumer Health, Inc.
Parsippany, NJ 07054-0622 USA
©2009
Visit us at www.excedrin.com
2005826A