Headache Extra Strength, 25ct Unit Dose Box, Lil' Drug Store Products, Inc. ®

Headache Extra Strength, 25ct Unit Dose Box, Lil' Drug Store Products, Inc. ®
SPL v2
SPL
SPL Set ID 0c41deda-490b-f5d2-e063-6394a90a5047
Route
ORAL
Published
Effective Date 2022-04-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Pill Appearance
Imprint: S53 Shape: oval Color: white Size: 18 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-04-19

Description

​Drug Facts

Purpose

Purposes Pain reliever Pain reliever Pain reliever aid


Medication Information

Purpose

Purposes Pain reliever Pain reliever Pain reliever aid

Description

​Drug Facts

Uses

Uses

temporarily relieves minor aches and pains due to:

  • headache
  • a cold
  • arthritis
  • muscular aches
  • toothache
  • premenstrual & menstrual cramps
Purposes

Purposes

Pain reliever

Pain reliever

Pain reliever aid

Warnings

Warnings

Directions

Directions

  • do not use more than directed
  • drink a full glass of water with each dose
adults and children (12 years and over) 2 caplets every 6 hours as needed; 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.
Drug Facts

​Drug Facts

Allergy Alert

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

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
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 heartbeat.

Other Information

Other information

  • store at 68°-77°F (20°-25°C); excursions permitted between 59°-86°F (15°-30°C)
  • avoid excessive heat and humidity
  • each caplet contains: Magnesium 0.58 mg
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.

Active Ingredients

Active ingredients (in each caplet)

Acetaminophen 250 mg

Aspirin (NSAID*) 250 mg

Caffeine 65 mg

*nonsteroidal anti-inflammatory drug

Inactive Ingredients

Inactive ingredients

colloidal silicon dioxide, hypromellose, microcrystalline cellulose, polyethylene glycol, povidone K30, pregelatinized starch, stearic acid, talc

Questions Or Comments?

Questions or comments?

call toll-free 1-877-507-6516 (M-F 8AM-4:30PM CST)

Ask A Doctor Before Use

Ask a doctor before use if

  • you have liver disease
  • the 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 A Doctor If

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 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 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.

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 (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Ask A Doctor Or Pharmacist Before Use

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
Extra Strength Headache Relief, 25ct, Lil' Drug Store ®

Extra Strength

Headache Relief

Acetaminophen 250 mg Pain Reliever

Aspirin (NSAID*) 250 mg Pain Reliever

Caffeine 65 mg Pain Reliever Aid

[caplets image]

ACTUAL SIZE

50 CPLETS

25 POUCHES 2 CAPLETS PER POUCH

[Lil' Drug Store ® logo]


Structured Label Content

Uses

Uses

temporarily relieves minor aches and pains due to:

  • headache
  • a cold
  • arthritis
  • muscular aches
  • toothache
  • premenstrual & menstrual cramps
Purposes

Purposes

Pain reliever

Pain reliever

Pain reliever aid

Warnings

Warnings

Directions

Directions

  • do not use more than directed
  • drink a full glass of water with each dose
adults and children (12 years and over) 2 caplets every 6 hours as needed; not more than 8 caplets in 24 hours
children under 12 years ask a doctor

Do Not Use (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.
Drug Facts

​Drug Facts

Allergy Alert (Allergy alert)

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 (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
Caffeine Warning (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 heartbeat.

Other Information (Other information)

Other information

  • store at 68°-77°F (20°-25°C); excursions permitted between 59°-86°F (15°-30°C)
  • avoid excessive heat and humidity
  • each caplet contains: Magnesium 0.58 mg
Reye’s Syndrome (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.

Active Ingredients (Active ingredients)

Active ingredients (in each caplet)

Acetaminophen 250 mg

Aspirin (NSAID*) 250 mg

Caffeine 65 mg

*nonsteroidal anti-inflammatory drug

Inactive Ingredients (Inactive ingredients)

Inactive ingredients

colloidal silicon dioxide, hypromellose, microcrystalline cellulose, polyethylene glycol, povidone K30, pregelatinized starch, stearic acid, talc

Questions Or Comments? (Questions or comments?)

Questions or comments?

call toll-free 1-877-507-6516 (M-F 8AM-4:30PM CST)

Ask A Doctor Before Use (Ask a doctor before use)

Ask a doctor before use if

  • you have liver disease
  • the 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)

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 A Doctor If (Stop use and ask a doctor if)

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 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)

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.

Keep Out of Reach of Children. (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 (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Ask A Doctor Or Pharmacist Before Use (Ask a doctor or pharmacist before use)

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
Extra Strength Headache Relief, 25ct, Lil' Drug Store ®

Extra Strength

Headache Relief

Acetaminophen 250 mg Pain Reliever

Aspirin (NSAID*) 250 mg Pain Reliever

Caffeine 65 mg Pain Reliever Aid

[caplets image]

ACTUAL SIZE

50 CPLETS

25 POUCHES 2 CAPLETS PER POUCH

[Lil' Drug Store ® logo]


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)