PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.
Principal Display Panel NDC 0067-8104-50 EXCEDRIN EXTRA STRENGTH Acetaminophen, Aspirin (NSAID) and Caffeine Pain Relieve/Pain Reliever Aid 50 CAPLETS DO NOT USE IF PRINTED FOIL SEAL UNDER CAP IS BROKEN OR MISSING KEEP BOX FOR REFERENCE Distributed by: Novartis Consumer Health, Inc. Parsippany, NJ 07054-0622 2014 Visit us at www.excedrin.com 12043
OTC - ACTIVE INGREDIENT SECTION.
Active ingredients (in each caplet) Acetaminophen 250 mg Aspirin 250 mg (NSAID*) Caffeine 65 mg *nonsteroidal anti-inflammatory drug
INDICATIONS & USAGE SECTION.
Uses temporarily relieves minor aches and pains due to: headache a cold arthritis muscular aches toothache premenstrual & menstrual cramps
DOSAGE & ADMINISTRATION SECTION.
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
SPL UNCLASSIFIED SECTION.
Other information store at 20- 25C (68- 77F) close cap tightly after use read all product information before using. Keep this box for important information
INACTIVE INGREDIENT SECTION.
Inactive ingredients carnauba wax, crospovidone, FD&C blue #1 aluminum lake, hypromellose, microcrystalline cellulose, povidone, pregelatinized starch, propylene glycol, saccharin sodium, stearic acid, titanium dioxide
OTC - QUESTIONS SECTION.
Questions or comments? 1-800-468-7746
Warnings Reyes 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 Reyes 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 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 doctors 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 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 occur These could be signs of a serious condition 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.
OTC - PURPOSE SECTION.
Purposes Pain reliever Pain reliever Pain reliever aid