Extra Strength Headache Relief

Extra Strength Headache Relief
SPL v9
SPL
SPL Set ID b3a06e4b-0b31-4e2a-8dd1-9de85760477b
Route
ORAL
Published
Effective Date 2022-10-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (250 mg) Aspirin (65 mg) Caffeine
Inactive Ingredients
Silicon Dioxide Talc Microcrystalline Cellulose Polyethylene Glycol, Unspecified Hypromellose, Unspecified Povidone K30 Stearic Acid Starch, Corn

Identifiers & Packaging

Pill Appearance
Imprint: S53 Shape: oval Color: white Size: 18 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Completed Since 2021-08-25 Until 2027-06-18

Description

Active ingredient (in each caplet) Purpose Acetaminophen 250 mg Pain reliever Aspirin 250 mg (NSAID) nonsteroidal anti-inflammatory drug Pain reliever Caffeine 65 mg Pain reliever aid

Purpose

Pain reliever/Pain reliever aid


Medication Information

Purpose

Pain reliever/Pain reliever aid

Description

Active ingredient (in each caplet) Purpose Acetaminophen 250 mg Pain reliever Aspirin 250 mg (NSAID) nonsteroidal anti-inflammatory drug Pain reliever Caffeine 65 mg Pain reliever aid

Uses

temporarily relieves minor aches and pains due to:

  • headache
  • a cold
  • arthritis
  • muscular aches
  • sinusitis
  • toothache
  • premenstrual & menstrual cramps
Section 42229-5

*This product is not manufactured or distributed by GSK Consumer Healthcare, distributor of EXCEDRIN® EXTRA STRENGTH tablets.

Distributed by: Lil’ Drug Store Products, Inc., Cedar Rapids, IA 52404

Made in India

Directions
  • do not use more than directed (see OVERDOSE WARNING)
  • 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
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.
Allergy Alert

Aspirin may cause a severe allergic reaction which may include:

  • hives
  • facial swelling
  • asthma (wheezing)
  • shock

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 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
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.

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.

Other Information
  • Each caplet contains: Magnesium 0.58 mg
  • store at controlled room temperature 20º - 25º C (68º - 77º F)
  • read all product information before using. Keep this box for important information
Inactive Ingredients

colloidal silicon dioxide, hypromellose, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, stearic acid, talc

Questions Or Comments

1-888-333-9792

Ask 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
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
Stop Use and Ask 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 loss of hearing occurs
  • 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
  • any new symptoms appear

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 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

Overdose Warning

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. 1(800) 222-1222

Active Ingredient (in Each Caplet)
Active ingredient (in each caplet) Purpose
Acetaminophen 250 mg Pain reliever
Aspirin 250 mg (NSAID)
nonsteroidal anti-inflammatory drug
Pain reliever
Caffeine 65 mg Pain reliever aid

Principal Display Panel 25 Count Box

COMPARE TO THE ACTIVE INGREDIENTS IN

EXCEDRIN® EXTRA STRENGTH

Extra Strength

Headache

Relief

Acetaminophen Aspirin (NSAID)

and Caffeine

Pain Reliever/Fever Reducer

25 POUCHES

2 CAPLETS PER POUCH

Ask A Doctor Or Pharmacist Before Use If You Are
  • any other drug containing an NSAID (prescription or nonprescription)
  • a prescription drug for diabetes, gout, or arthritis
  • any other drug, or are under a doctor's care for any serious condition
  • a blood thinning (anticoagulant) or steroid drug

Structured Label Content

Uses (USES)

temporarily relieves minor aches and pains due to:

  • headache
  • a cold
  • arthritis
  • muscular aches
  • sinusitis
  • toothache
  • premenstrual & menstrual cramps
Section 42229-5 (42229-5)

*This product is not manufactured or distributed by GSK Consumer Healthcare, distributor of EXCEDRIN® EXTRA STRENGTH tablets.

Distributed by: Lil’ Drug Store Products, Inc., Cedar Rapids, IA 52404

Made in India

Purpose

Pain reliever/Pain reliever aid

Directions
  • do not use more than directed (see OVERDOSE WARNING)
  • 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
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.
Allergy Alert (Allergy alert)

Aspirin may cause a severe allergic reaction which may include:

  • hives
  • facial swelling
  • asthma (wheezing)
  • shock

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 (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
Reye's Syndrome (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.

Caffeine Warning (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.

Other Information
  • Each caplet contains: Magnesium 0.58 mg
  • store at controlled room temperature 20º - 25º C (68º - 77º F)
  • read all product information before using. Keep this box for important information
Inactive Ingredients

colloidal silicon dioxide, hypromellose, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, stearic acid, talc

Questions Or Comments (Questions or Comments)

1-888-333-9792

Ask Doctor Before Use If (Ask 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
Stomach Bleeding Warning (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
Stop Use and Ask Doctor If (Stop use and ask 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 loss of hearing occurs
  • 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
  • any new symptoms appear

These could be signs of a serious condition

If Pregnant Or Breast Feeding (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 (Keep out of reach of children)

Overdose Warning

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. 1(800) 222-1222

Active Ingredient (in Each Caplet) (Active Ingredient (in each caplet))
Active ingredient (in each caplet) Purpose
Acetaminophen 250 mg Pain reliever
Aspirin 250 mg (NSAID)
nonsteroidal anti-inflammatory drug
Pain reliever
Caffeine 65 mg Pain reliever aid

Principal Display Panel 25 Count Box (Principal Display Panel- 25 Count Box)

COMPARE TO THE ACTIVE INGREDIENTS IN

EXCEDRIN® EXTRA STRENGTH

Extra Strength

Headache

Relief

Acetaminophen Aspirin (NSAID)

and Caffeine

Pain Reliever/Fever Reducer

25 POUCHES

2 CAPLETS PER POUCH

Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)
  • any other drug containing an NSAID (prescription or nonprescription)
  • a prescription drug for diabetes, gout, or arthritis
  • any other drug, or are under a doctor's care for any serious condition
  • a blood thinning (anticoagulant) or steroid drug

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)