Gc 226l (216)
bf365bfc-35cc-47f9-a50b-ff2b38d7316b
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
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 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.
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 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
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
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 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.
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 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
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: 2026-02-15T12:04:20.448320 · Updated: 2026-03-14T23:04:59.717126