INDICATIONS & USAGE SECTION.
Uses temporarily relieves minor aches and pains due to: toothache arthritis a cold headache muscular aches premenstrual and menstrual cramps
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.
Principal Display Panel Well at Walgreens WALGREENS PHARMACIST RECOMMENDED NDC 0363-0159-15 EXTRA STRENGTH Headache Relief Acetaminophen / Aspirin (NSAID) / Caffeine / Pain Reliever / Pain Reliever Aid 50 ANALGESIC TABLETS Compare to Excedrin Extra Strength active ingredients Walgreens Pharmacist Survey Study, November 2016. This product is not manufactured or distributed by Novartis AG, owner of the registered trademark Excedrin Extra Strength. 50844REV0117C15915 DISTRIBUTED BY: WALGREEN CO. 200 WILMOT RD., DEERFIELD, IL 60015 100% SATISFACTION GUARANTEED walgreens.com 2017 Walgreen Co. TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING Walgreens 44-159B
OTC - ACTIVE INGREDIENT SECTION.
Active ingredients (in each tablet) Acetaminophen 250 mg Aspirin 250 mg (NSAID)* Caffeine 65 mg *nonsteroidal anti-inflammatory drug
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 tablets every 6 hours do not take more than 8 tablets in 24 hours children under 12 years: ask a doctor
SPL UNCLASSIFIED SECTION.
Questions or comments? 1-800-426-9391
INACTIVE INGREDIENT SECTION.
Inactive ingredients corn starch, crospovidone, hypromellose, microcrystalline cellulose, povidone, propylene glycol, sodium lauryl sulfate, sodium starch glycolate, stearic acid, titanium dioxide
STORAGE AND HANDLING SECTION.
Other information store at25C (77F); excursions permitted between15-30C (59-86F) see end flap for expiration date and lot number
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 shock facial swelling asthma (wheezing) 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 4,000 mg in 24 hours, which is the maximum daily amount 3 or more alcoholic drinks every day while using this product with other drugs containing acetaminophen 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 heartbeat. Do not use if you 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 are taking a diuretic you have high blood pressure, heart disease, liver cirrhosis or kidney disease you have asthma Ask a doctor or pharmacist before use if you are taking a prescription drug for diabetes, gout, or arthritis taking any other drug or are under a doctor's care for any serious condition Stop use and ask a doctor if 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 an allergic reaction occurs. Seek medical help right away. any new symptoms appear 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 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 accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
OTC - PURPOSE SECTION.
Purpose Pain reliever Pain reliever Pain reliever aid