FDA Label for Xpect Pain Away Extra Strength

Otc - Active Ingredient

Active ingredients (in each tablet)

Acetaminophen 250 mg

Aspirin 250 mg (NSAID)*

Caffeine 65 mg

*nonsteroidal anti-inflammatory drug

Otc - Purpose

Purpose

Pain reliever

Pain reliever

Pain reliever aid

Indications & Usage

Uses

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

Warnings

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 bahavior with nausea and vomiting occur, consult a doctor becuase 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: • shock • facial swelling • hives • 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 of acetaminophen in 24 hours
• 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

• 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
• are age 60 or older
• 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. 

Otc - Do Not Use

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
• if you have ever had an allergic reaction to this product or any of its ingredients

Otc - Ask Doctor

Ask a doctor before use if

• you have liver disease
• you have asthma
• 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

Otc - Ask Doctor/Pharmacist

Ask a doctor or pharmacist before use if you are

• taking a precription drug for diabetes, gout, or arthritis
• taking any other drug or are under a doctor's care for any serious condition 

Otc - Stop Use

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 • have bloody or black stools • vomit blood • have stomach pain that does not get better
• ringing in the ears or a loss of hearing occurs
• redness or swelling is present
• pain gets worse or lasts for more than 10 days
• fever gets worse or lasts for more than 3 days
• new symptoms occur

These could be signs of a serious condition. 

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use aspirin at 20 weeks or later in pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms. 

Dosage & Administration

Directions

• do not take 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 

Other Safety Information

Other information

• store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
• see packet for expiration date and lot number 

Inactive Ingredient

Inactive ingredients

corn starch, crospovidone, hypromellose, microcrystalline cellulose, povidone, propylene glycol, sodium lauryl sulfate, sodium starch glycolate, stearic acid, titanium dioxide 

Otc - Questions

Questions? 

1-877-973-2811 Monday-Friday 8:00 AM-5:00 PM

Principal Display Panel - 42961-234-02

†Compare to the active ingredients of Excedrin®

EXTRA STRENGTH PAIN AWAY®

Active Ingredients:

Acetaminophen

Aspirin (NSAID)

Caffeine

Pain Reliever / Pain Reliever Aid

• Relief from headaches
• Contains caffeine

Xpect® First aid

WORKPLACE READY®

• Single Dose
• Tamper Evident

100 Tablets • 50 Packets (2 tablets per packet) per Box

†This product is not manufactured or distributed by GSK Consumer Healthcare SARL, owner of the registered trademark Excedrin®.

111689

100_Box - 100 Box

Principal Display Panel - 42961-234-03

†Compare to the active ingredients of Excedrin®

EXTRA STRENGTH PAIN AWAY®

Active Ingredients:

Acetaminophen

Aspirin (NSAID)

Caffeine

Pain Reliever / Pain Reliever Aid

• Relief from headaches
• Contains caffeine

Xpect® First aid

WORKPLACE READY®

• Single Dose
• Tamper Evident

250 Tablets • 125 Packets (2 tablets per packet) per Box

†This product is not manufactured or distributed by GSK Consumer Healthcare SARL, owner of the registered trademark Excedrin®.

111699

250_Box - 250 Box