Xpect Pain Away Extra Strength

Xpect Pain Away Extra Strength
SPL v3
SPL
SPL Set ID 1269d069-afaf-4ca5-b369-f74249a348db
Route
ORAL
Published
Effective Date 2025-09-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (250 mg) Aspirin (65 mg) Caffeine
Inactive Ingredients
Starch, Corn Crospovidone Hypromellose, Unspecified Microcrystalline Cellulose Povidone Propylene Glycol Sodium Lauryl Sulfate Sodium Starch Glycolate Type A Stearic Acid Titanium Dioxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 2023-07-26 Until 2024-12-27

Description

Active ingredients (in each tablet) Acetaminophen 250 mg Aspirin 250 mg (NSAID)* Caffeine 65 mg *nonsteroidal anti-inflammatory drug


Medication Information

Warnings and Precautions

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. 

Indications and Usage

Uses

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

Active ingredients (in each tablet) Acetaminophen 250 mg Aspirin 250 mg (NSAID)* Caffeine 65 mg *nonsteroidal anti-inflammatory drug

Section 50565-1

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. 

Section 50566-9

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. 

Section 50568-5

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 
Section 50569-3

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
Section 50570-1

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
Section 51727-6

Inactive ingredients

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

Section 53413-1

Questions? 

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

Section 53414-9

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.

Section 55105-1

Purpose

Pain reliever

Pain reliever

Pain reliever aid

Section 55106-9

Active ingredients (in each tablet)

Acetaminophen 250 mg

Aspirin 250 mg (NSAID)*

Caffeine 65 mg

*nonsteroidal anti-inflammatory drug

Section 60561-8

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 
Principal Display Panel 42961 234 04

†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

80 Tablets • 40 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®.

Principal Display Panel 42961 234 05

†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

160 Tablets • 80 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®.


Structured Label Content

Indications and Usage (34067-9)

Uses

  • temporarily relieves minor aches and pains due to: • a cold • toothache • headache • muscular aches • arthritis • premenstrual and menstrual cramps 
Dosage and Administration (34068-7)

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 
Warnings and Precautions (34071-1)

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. 

Section 50565-1 (50565-1)

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. 

Section 50566-9 (50566-9)

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. 

Section 50568-5 (50568-5)

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 
Section 50569-3 (50569-3)

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
Section 50570-1 (50570-1)

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
Section 51727-6 (51727-6)

Inactive ingredients

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

Section 53413-1 (53413-1)

Questions? 

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

Section 53414-9 (53414-9)

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.

Section 55105-1 (55105-1)

Purpose

Pain reliever

Pain reliever

Pain reliever aid

Section 55106-9 (55106-9)

Active ingredients (in each tablet)

Acetaminophen 250 mg

Aspirin 250 mg (NSAID)*

Caffeine 65 mg

*nonsteroidal anti-inflammatory drug

Section 60561-8 (60561-8)

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 
Principal Display Panel 42961 234 04 (Principal Display Panel - 42961-234-04)

†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

80 Tablets • 40 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®.

Principal Display Panel 42961 234 05 (Principal Display Panel - 42961-234-05)

†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

160 Tablets • 80 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®.


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