Excedrin Extra Strength and Excedrin Tension Headache ACETAMINOPHEN ASPIRIN NSAID AND CAFFEINE HALEON US HOLDINGS LLC FDA Approved Uses • temporarily relieves minor aches and pains due to: • headache • muscular aches Uses • temporarily relieves minor aches and pains due to: • headache • a cold • arthritis • muscular aches • toothache • premenstrual & menstrual cramps

Drug Facts

Composition & Profile

Active Ingredients
Active ingredients (in each caplet) Acetaminophen 500 mg Caffeine 65 mg Active ingredients (in each caplet) Acetaminophen 250 mg Aspirin 250 mg (NSAID*) Caffeine 65 mg *nonsteroidal anti-inflammatory drug
Inactive Ingredients
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 Inactive ingredients 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
Strengths
500 mg 65 mg 250 mg
Quantities
46177299 count 46172044 count
Treats Conditions
Uses Temporarily Relieves Minor Aches And Pains Due To Headache Muscular Aches Uses Temporarily Relieves Minor Aches And Pains Due To Headache A Cold Arthritis Muscular Aches Toothache Premenstrual Menstrual Cramps
Pill Appearance
Shape: oval Color: red Imprint: E

Identifiers & Packaging

Container Type BOTTLE
Packaging

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 ©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 46177299 46177299_Excedrin Tension HA_24 caps.JPG; Principal Display Panel (Excedrin Extra Strength) NDC 0067-2000-91 EXCEDRIN ® EXTRA STRENGTH Acetaminophen, Aspirin (NSAID) and Caffeine Pain Reliever / Pain Reliever Aid 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 ©2015 GSK group of companies or its licensor. All rights reserved. Visit us at www.excedrin.com DO NOT TAKE BOTH PRODUCTS AT THE SAME TIME. USE PRODUCTS AS DIRECTED. 46172044 46172044_Excedrin Extra Strength Caplets_100 ct

Package Descriptions
  • 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 ©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 46177299 46177299_Excedrin Tension HA_24 caps.JPG
  • Principal Display Panel (Excedrin Extra Strength) NDC 0067-2000-91 EXCEDRIN ® EXTRA STRENGTH Acetaminophen, Aspirin (NSAID) and Caffeine Pain Reliever / Pain Reliever Aid 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 ©2015 GSK group of companies or its licensor. All rights reserved. Visit us at www.excedrin.com DO NOT TAKE BOTH PRODUCTS AT THE SAME TIME. USE PRODUCTS AS DIRECTED. 46172044 46172044_Excedrin Extra Strength Caplets_100 ct

Overview

Uses • temporarily relieves minor aches and pains due to: • headache • muscular aches Uses • temporarily relieves minor aches and pains due to: • headache • a cold • arthritis • muscular aches • toothache • premenstrual & menstrual cramps

Indications & Usage

Uses • temporarily relieves minor aches and pains due to: • headache • muscular aches Uses • temporarily relieves minor aches and pains due to: • headache • a cold • arthritis • muscular aches • toothache • premenstrual & menstrual cramps

Dosage & Administration

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 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

Warnings & Precautions
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. 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. 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: 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 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: • 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 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 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.
Purpose

Purposes Pain reliever Pain reliever aid Purpose s Pain reliever Pain reliever Pain reliever aid

Do Not Use

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. 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.

Stop Use & Ask a Doctor

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 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: • 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 These could be signs of a serious condition

Keep Out of Reach of Children

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. 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.

Questions

Questions or comments? 1-800-468-7746 Questions or comments? 1-800-468-7746


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