Drug Facts

Drug Facts
SPL v3
SPL
SPL Set ID b3c7b322-fe13-4f66-9035-fd4c9bd97bf0
Route
ORAL
Published
Effective Date 2024-11-13
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 Starch, Corn Hypromelloses Cellulose, Microcrystalline Povidone Stearic Acid Talc Polyethylene Glycol, Unspecified

Identifiers & Packaging

Pill Appearance
Imprint: S53 Shape: capsule Color: white Size: 17 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Completed Since 2020-07-30 Until 2026-05-30

Description

Acetaminophen 250 mg Aspirin 250 mg (NSAID)* Caffeine 65 mg *nonsteroidal anti-inflammatory drug

Purpose

Pain reliever Pain reliever Pain reliever aid


Medication Information

Purpose

Pain reliever Pain reliever Pain reliever aid

Description

Acetaminophen 250 mg Aspirin 250 mg (NSAID)* Caffeine 65 mg *nonsteroidal anti-inflammatory drug

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

Pain reliever

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: 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.

Allergy alert: Aspirin may cause a severe allergic reaction, which may include:

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

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

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

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; do not take more than 8 caplets in 24 hours
  • children under 12 years: do not use unless directed by 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.
Package Label
TOPCARE HEALTH Extra Strength Headache Relief
Other Information
  • store between 20º-25ºC (68º-77ºF)
Inactive Ingredients

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

Questions Or Comments?

Call toll free 1-888-423-0139

Principal Display Panel

COMPARE TO EXCEDRIN® EXTRA STRENGTH ACTIVE INGREDIENTS

EXTRA STRENGTH

Headache Relief

ACETAMINOPHEN, ASPIRIN (NSAID) & CAFFEINE

PAIN RELIEVER • PAIN RELIEVER AID

CAPLETS

†This product is not manufactured or distributed by GSK Consumer Healthcare, distributor of Excedrin® Extra Strength.

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

DISTRIBUTED BY TOPCO ASSOCIATES LLC

ELK GROVE VILLAGE, IL 60007

[email protected]   www.topcarebrand.com

Stop Use and Ask Doctor If
  • an allergic reaction occurs. Seek medical help right away.
    • any new symptoms appear
  • 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
  • pain gets worse or lasts for more than 10 days
  • fever gets worse or lasts for more than 3 days
  • painful area is red or swollen

These could be signs of a serious condition.

Ask A doctor Before Use If
  • you have liver disease
  • stomach bleeding warning applies to you
  • you have asthma
  • you are taking a diuretic
  • you have a history of stomach problems, such as heartburn
  • you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
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.

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.

Active Ingredients (in Each Caplet)

Acetaminophen 250 mg

Aspirin 250 mg (NSAID)*

Caffeine 65 mg

*nonsteroidal anti-inflammatory drug

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

Structured Label Content

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

Pain reliever

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: 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.

Allergy alert: Aspirin may cause a severe allergic reaction, which may include:

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

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

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

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; do not take more than 8 caplets in 24 hours
  • children under 12 years: do not use unless directed by 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.
Package Label
TOPCARE HEALTH Extra Strength Headache Relief
Other Information (Other information)
  • store between 20º-25ºC (68º-77ºF)
Inactive Ingredients (Inactive ingredients)

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

Questions Or Comments? (Questions or comments?)

Call toll free 1-888-423-0139

Principal Display Panel

COMPARE TO EXCEDRIN® EXTRA STRENGTH ACTIVE INGREDIENTS

EXTRA STRENGTH

Headache Relief

ACETAMINOPHEN, ASPIRIN (NSAID) & CAFFEINE

PAIN RELIEVER • PAIN RELIEVER AID

CAPLETS

†This product is not manufactured or distributed by GSK Consumer Healthcare, distributor of Excedrin® Extra Strength.

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

DISTRIBUTED BY TOPCO ASSOCIATES LLC

ELK GROVE VILLAGE, IL 60007

[email protected]   www.topcarebrand.com

Stop Use and Ask Doctor If (Stop use and ask doctor if)
  • an allergic reaction occurs. Seek medical help right away.
    • any new symptoms appear
  • 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
  • pain gets worse or lasts for more than 10 days
  • fever gets worse or lasts for more than 3 days
  • painful area is red or swollen

These could be signs of a serious condition.

Ask A doctor Before Use If (Ask a doctor before use if)
  • you have liver disease
  • stomach bleeding warning applies to you
  • you have asthma
  • you are taking a diuretic
  • you have a history of stomach problems, such as heartburn
  • you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
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.)

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.

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

Acetaminophen 250 mg

Aspirin 250 mg (NSAID)*

Caffeine 65 mg

*nonsteroidal anti-inflammatory drug

Ask A Doctor Or Pharmacist Before Use If You Are (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

Advanced Ingredient Data


Raw Label Data

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