Gc 226l (216)
b670a898-2360-76e2-e053-2a95a90a3380
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
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
Uses
- temporarily relieves minor aches and pains
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 professionalbefore 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.
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 20°-25°C (68°-77°F); excursions permitted between 15°-30°C (59°-86°F)
- close cap tightly after use
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
Uses (USES)
- temporarily relieves minor aches and pains
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 professionalbefore 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.
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 20°-25°C (68°-77°F); excursions permitted between 15°-30°C (59°-86°F)
- close cap tightly after use
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)
Additional Information
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Source: dailymed · Ingested: 2026-02-15T12:07:16.183540 · Updated: 2026-03-14T23:10:32.676275