drug facts
081ca362-bfd1-4eeb-b2a1-b47f05ee0e2f
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
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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Source: dailymed · Ingested: 2026-02-15T11:55:46.455578 · Updated: 2026-03-14T22:53:43.600487