PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.
Principal Display Panel (Excedrin Tension Headache) NDC 0067-8139-02 EXCEDRIN TENSION HEADACHE Acetaminophen and Caffeine Pain Reliever / Pain Reliever Aid Aspirin Free 100 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 2016 GSK group of companies or its licensor. All rights reserved. Trademarks are owned by or licensed to the GSK group of companies Visit us at www.excedrin.com 46177300
OTC - ACTIVE INGREDIENT SECTION.
Active Ingredients (in each caplet) Acetaminophen 500 mg Caffeine 65 mg
INDICATIONS & USAGE SECTION.
Uses temporarily relieves minor aches and pain due to: oheadache muscular aches
DOSAGE & ADMINISTRATION SECTION.
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
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 benzoic acid, D&C red #27 aluminum lake, FD&C blue #2 aluminum lake, FD&C yellow #6 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, stearic acid, talc, titanium dioxide
OTC - QUESTIONS SECTION.
Questions or comments? 1-800-452-0051
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 heart beat 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. Ask a doctor before use if you have liver disease 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 If pregnant or breast-feeding, ask a health professional before use. 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 aid