Gc 226l (216)

Gc 226l (216)
SPL v1
SPL
SPL Set ID bf365bfc-35cc-47f9-a50b-ff2b38d7316b
Route
ORAL
Published
Effective Date 2024-11-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Pill Appearance
Imprint: 44;334 Shape: capsule Color: white Size: 17 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-02-01

Description

ACETAMINOPHEN 250 MG ASPIRIN 250 MG (nsaid-nonsteroidal anti-inflammatory drug) CAFFEINE 65 MG

Purpose

PAIN RELIEVER - PAIN RELIEVER AID


Medication Information

Purpose

PAIN RELIEVER - PAIN RELIEVER AID

Description

ACETAMINOPHEN 250 MG ASPIRIN 250 MG (nsaid-nonsteroidal anti-inflammatory drug) CAFFEINE 65 MG

Section 50565-1

Keep out of reach of children. In case of accidental overdose, get medical help or contact

a Poison Control Center (1-800-222-1222) 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 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

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
  • taking 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 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
  • 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 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.

Purposes

PAIN RELIEVER - PAIN RELIEVER AID

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: Aspirin may cause a severe allergic reaction which may include:

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

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include: • rash

• skin reddening • blisters 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) • are age 60 or older

• 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 heartbeat.

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: ask a doctor
Package Label
Other Information
  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
Inactive Ingredients

corn starch, crospovidone, hypromellose,

microcrystalline cellulose, povidone, propylene glycol, sodium lauryl sulfate,

sodium starch glycolate, stearic acid, titanium dioxide

Questions Or Comments?

1-800-540-3765

Active Ingredients (in Each Caplet)

ACETAMINOPHEN 250 MG

ASPIRIN 250 MG (nsaid-nonsteroidal anti-inflammatory drug)

CAFFEINE 65 MG


Structured Label Content

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 (1-800-222-1222) 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 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

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
  • taking 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 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
  • 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 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.

Purposes

PAIN RELIEVER - PAIN RELIEVER AID

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

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: Aspirin may cause a severe allergic reaction which may include:

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

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include: • rash

• skin reddening • blisters 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) • are age 60 or older

• 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 heartbeat.

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: ask a doctor
Package Label (Package label)
Other Information (Other information)
  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
Inactive Ingredients (INACTIVE INGREDIENTS)

corn starch, crospovidone, hypromellose,

microcrystalline cellulose, povidone, propylene glycol, sodium lauryl sulfate,

sodium starch glycolate, stearic acid, titanium dioxide

Questions Or Comments? (Questions or comments?)

1-800-540-3765

Active Ingredients (in Each Caplet) (Active ingredients (in each caplet))

ACETAMINOPHEN 250 MG

ASPIRIN 250 MG (nsaid-nonsteroidal anti-inflammatory drug)

CAFFEINE 65 MG


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)