FDA Label for Excedrin Extra Strength Pain Reliever

View Indications, Usage & Precautions

Excedrin Extra Strength Pain Reliever Product Label

The following document was submitted to the FDA by the labeler of this product Glaxosmithkline Consumer Healthcare Holdings (us) Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Excedrin Tension Headache

[Enter Generic Section here]

Active Ingredients (In Each Caplet)

Acetaminophen 500 mg

Caffeine 65 mg

Acetaminophen 250 mg

Aspirin 250 mg (NSAID*)

Caffeine 65 mg

*nonsteroidal anti-inflammatory drug

Purposes

Pain reliever

Pain reliever aid

Pain reliever

Pain reliever aid

Uses

•temporarily relieves minor aches and pains due to:
•headache
•muscular aches

•temporarily relieves minor aches and pains due to:
- oheadache
- oa cold
- oarthritis
- omuscular aches
- otoothache
- opremenstrual & menstrual cramps

Warnings

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.

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take

•more than 6 caplets 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

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 heartbeat.

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 caplets 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

Do Not Use

•if you are allergic to acetaminophen
•with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

•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

•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 the blood thinning drug warfarin

Stop Use And Ask A Doctor If

•any new symptoms occur
•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

These could be signs of a serious condition

•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 a loss of hearing occurs
- •painful area is red or swollen
- •pain gets worse or last for more than 10 days
- •fever gets worse or lasts for more than 3 days
- •any new symptoms occur

If Pregnant Or Breast-Feeding,

ask a health professional before use.

ask a health professional before use. It is especially important not to use aspirin during the last three 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
•adults and children 12 years and over: take 2 caplets every 6 hours; not more than 6 caplets in 24 hours
•children under 12 years: ask a doctor

•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

•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.

•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 red no. 27 aluminum lake, FD&C blue no. 2 aluminum lake, FD&C yellow no. 6 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, stearic acid, talc, titanium dioxide

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

Questions Or Comments?

1-800-468-7746

Excedrin Extra Strength

[Enter Generic Section here]

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

Principal Display Panel (Excedrin Tension Headache)

NDC 0067-8139-01

EXCEDRIN_®

TENSION HEADACHE

Acetaminophen and Caffeine

Pain Reliever / Pain Reliever Aid

Aspirin Free

24 CAPLETS

TAMPER-EVIDENT BOTTLE

DO NOT USE IF INNER FOIL SEAL IMPRINTED WITH “SEALED for YOUR PROTECTION” IS BROKEN OR MISSING

Distributed by: GSK Consumer Healthcare,

Warren, NJ 07059

Visit us at www.excedrin.com

46177299

Principal Display Panel (Excedrin Extra Strength)

NDC 0067-2000-91