370r 11673-070 Headache Relief
8e953cef-135e-f1aa-e053-2995a90aaa8b
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Description
Active ingredients (in each caplet) Acetaminophen 250 mg Aspirin 250 mg (NSAID*) Caffeine 65 mg *nonsteroidal anti-inflammatory drug
Medication Information
Warnings and Precautions
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
-asthma (wheezing)
-shock
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.
Indications and Usage
Uses
- temporarily relieves minor aches and pains due to:
-headache
-a cold
-arthritis
-muscular aches
-toothache
-premenstrual and menstrual cramps
Dosage and Administration
Directions
- do not use more than directed
- drink a full glass of water with each dose
- adults and children 12 years of age and over: take 2 caplets every 6 hours; not more than 8 caplets in 24 hours
- children under 12 years: ask a doctor
Description
Active ingredients (in each caplet) Acetaminophen 250 mg Aspirin 250 mg (NSAID*) Caffeine 65 mg *nonsteroidal anti-inflammatory drug
Section 50565-1
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.
Section 50566-9
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 occur
These could be signs of a serious condition.
Section 50568-5
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
Section 50569-3
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
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.
Section 51727-6
Inactive ingredients
carnauba wax, colloidal silicon dioxide, hypromellose, microcrystalline cellulose, mineral oil, povidone, pregelatinized starch, sodium starch glycolate, stearic acid, titanium dioxide
Section 51945-4
Section 53413-1
Questions or comments? Call 1-800-910-6874
Section 53414-9
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.
Section 55105-1
Purposes
Pain reliever
Pain reliever aid
Section 55106-9
Active ingredients (in each caplet)
Acetaminophen 250 mg
Aspirin 250 mg (NSAID*)
Caffeine 65 mg
*nonsteroidal anti-inflammatory drug
Section 60561-8
Other information
- store at 20°- 25°C (68°- 77°F); excursions permitted between 15°-30°C (59°-86°F)
- use by expiration date on package
Structured Label Content
Indications and Usage (34067-9)
Uses
- temporarily relieves minor aches and pains due to:
-headache
-a cold
-arthritis
-muscular aches
-toothache
-premenstrual and menstrual cramps
Dosage and Administration (34068-7)
Directions
- do not use more than directed
- drink a full glass of water with each dose
- adults and children 12 years of age and over: take 2 caplets every 6 hours; not more than 8 caplets in 24 hours
- children under 12 years: ask a doctor
Warnings and Precautions (34071-1)
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
-asthma (wheezing)
-shock
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.
Section 50565-1 (50565-1)
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.
Section 50566-9 (50566-9)
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 occur
These could be signs of a serious condition.
Section 50568-5 (50568-5)
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
Section 50569-3 (50569-3)
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
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.
Section 51727-6 (51727-6)
Inactive ingredients
carnauba wax, colloidal silicon dioxide, hypromellose, microcrystalline cellulose, mineral oil, povidone, pregelatinized starch, sodium starch glycolate, stearic acid, titanium dioxide
Section 51945-4 (51945-4)
Section 53413-1 (53413-1)
Questions or comments? Call 1-800-910-6874
Section 53414-9 (53414-9)
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.
Section 55105-1 (55105-1)
Purposes
Pain reliever
Pain reliever aid
Section 55106-9 (55106-9)
Active ingredients (in each caplet)
Acetaminophen 250 mg
Aspirin 250 mg (NSAID*)
Caffeine 65 mg
*nonsteroidal anti-inflammatory drug
Section 60561-8 (60561-8)
Other information
- store at 20°- 25°C (68°- 77°F); excursions permitted between 15°-30°C (59°-86°F)
- use by expiration date on package
Advanced Ingredient Data
Raw Label Data
All Sections (JSON)
Additional Information
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Source: dailymed · Ingested: 2026-02-15T12:03:38.224107 · Updated: 2026-03-14T23:03:48.236290