drug facts

drug facts
SPL v1
SPL
SPL Set ID 081ca362-bfd1-4eeb-b2a1-b47f05ee0e2f
Route
oral
Published
Effective Date 2013-09-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
acetaminophen (250 mg) aspirin (65 mg) caffeine
Inactive Ingredients
benzoic acid carnauba wax cellulose, microcrystalline dimethicone 410 fd&c blue no. 1 hydroxypropyl cellulose hypromellose 2910 (15 mpa.s) light mineral oil polysorbate 20 povidone propylene glycol sorbitan monolaurate stearic acid titanium dioxide

Identifiers & Packaging

Pill Appearance
Imprint: E Shape: round Color: white Size: 11 mm Score: 1
Marketing Status
otc monograph not final active Since 2013-01-01

Purpose

Pain reliever Pain reliever Pain reliever aid

Description

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


Medication Information

Active Ingredient

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
    • sinusitis
    • toothache
    • premenstrual & menstrual cramps
Purpose

Pain reliever

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 tablets  every 6 hours; not more than 8 tables  in 24 hours
  • children under 12 years: ask a doctor
Inactive Ingredients

benzoic acid, carnauba wax, FD&C blue #1, hydroxypropyl cellulose, hypromellose, light mineral oil, microcrystalline cellulose, polysorbate 20, povidone, propylene glycol, simethicone emulsion, sorbitan monolaurate, stearic acid, titanium dioxide

Description

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

Principal Display Panel

Do Not Use
  • if you have ever had an allergic reaction to 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
Liver Warning:

This product contains acetaminophen. Severe liver damage may occur if you take

  • more than 8 tables 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

 

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.

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 
  • store at controlled room temperature 200 -  250 C (680 -  770 F)
  • read all product information before using. Keep this box for important information

 

Questions Or Comments

1-800-468-7746

This product is supplied by State of Florida DOH Central Pharmacy as follows:

NDC Strength Quantity/Form Color Source Prod. Code
53808-0834-1 250 mg / 250 mg / 65 mg 30 Tablets in a Blister Pack White 0067-2030

This product was Manufactured By:

Novartis Pharmaceuticals Corporation

One Health Plaza


And Repackaged By:

State of Florida DOH Central Pharmacy

104-2 Hamilton Park Drive

Tallahassee, FL 32304

United States

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
  • high blood pressure
  • you have asthma
Stomach Bleeding Warning:

This product contains a nonsteroidal anti-inflammatory drug (NSAID), which may cause 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 an NSAID (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 os 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
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.

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

 


Structured Label Content

Active Ingredient (Active ingredient (in each tablet))

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
    • sinusitis
    • toothache
    • premenstrual & menstrual cramps
Purpose

Pain reliever

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 tablets  every 6 hours; not more than 8 tables  in 24 hours
  • children under 12 years: ask a doctor
Inactive Ingredients (Inactive ingredients)

benzoic acid, carnauba wax, FD&C blue #1, hydroxypropyl cellulose, hypromellose, light mineral oil, microcrystalline cellulose, polysorbate 20, povidone, propylene glycol, simethicone emulsion, sorbitan monolaurate, stearic acid, titanium dioxide

Principal Display Panel

Do Not Use (Do not use)
  • if you have ever had an allergic reaction to 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
Liver Warning: (Liver warning:)

This product contains acetaminophen. Severe liver damage may occur if you take

  • more than 8 tables 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

 

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.

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  (Other information )
  • store at controlled room temperature 200 -  250 C (680 -  770 F)
  • read all product information before using. Keep this box for important information

 

Questions Or Comments (Questions or comments)

1-800-468-7746

This product is supplied by State of Florida DOH Central Pharmacy as follows:

NDC Strength Quantity/Form Color Source Prod. Code
53808-0834-1 250 mg / 250 mg / 65 mg 30 Tablets in a Blister Pack White 0067-2030

This product was Manufactured By:

Novartis Pharmaceuticals Corporation

One Health Plaza


And Repackaged By:

State of Florida DOH Central Pharmacy

104-2 Hamilton Park Drive

Tallahassee, FL 32304

United States

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
  • high blood pressure
  • you have asthma
Stomach Bleeding Warning: (Stomach bleeding warning:)

This product contains a nonsteroidal anti-inflammatory drug (NSAID), which may cause 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 an NSAID (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 os 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
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.

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

 


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