5004-cvs
6deb854f-863e-24ad-e053-2991aa0afb17
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
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 ■ shock ■ asthma (wheezing)
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.
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take: ■ with other drugs containing acetaminophen ■ more than 8 caplets in 24 hours, which is the maximum daily amount ■ 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 ■ take more or for a longer time than directed ■ 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
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.
Uses
■ temporarily relieves minor aches and pains due to: ■ headache ■ muscular aches ■ a cold ■ arthritis ■ toothache ■ premenstrual and menstrual cramps
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
■ do not take more than 8 caplets in 24 hours
■ children under 12 years: ask a doctor
Other Information
■ Store in a dry place at 15° – 30°C (59° – 86°F)
■ use by expiration date on package
Description
Active ingredients (in each caplet) Acetaminophen 250 mg Aspirin 250 mg (NSAID*) Caffeine 65 mg *nonsteroidal anti-inflammatory drug
Section 34088-5
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 42229-5
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
†CVS™ is not affiliated with the owner of the registered trademark Excedrin® Extra Strength Headache.
Distributed by:
CVS Pharmacy, Inc.
One CVS Drive
Woonsocket, RI 02895
© 2025 CVS/pharmacy
CVS.com® 1-800-SHOP CVS
Section 50565-1
Keep out of reach of children.
Section 51727-6
hypromellose, maltodextrin, microcrystalline cellulose, polydextrose, polyvinylpyrrolidone, pregelatinized starch, silica, starch, stearic acid, talc, titanium dioxide, triglycerides
Section 51945-4
VALUE SIZE
CVS™
NDC 69842-541-17
Extra Strength HEADACHE RELIEF
Acetaminophen, 250 mg
Aspirin (NSAID), 250 mg
Caffeine, 65 mg
Pain Reliever, Pain Reliever Aid
Compare to Excedrin® Extra Strength Headache active ingredients†
300 CAPLETS
Section 55105-1
Purpose
Pain reliever
Pain reliever
Pain reliever aid
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.
Drug Facts
Active ingredients (in each caplet)
Acetaminophen 250 mg
Aspirin 250 mg (NSAID*)
Caffeine 65 mg
*nonsteroidal anti-inflammatory drug
Questions Or Comments?
1-800-231-4670
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 have asthma
■ you are taking a diuretic
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 ■ have bloody or black stools ■ vomit blood
■ have stomach pain that does not get better
■ ringing in the ears or loss of hearing occurs
■ pain gets worse or lasts for more than 10 days
■ fever gets worse or lasts for more than 3 days
■ painful area is red or swollen
■ any new symptoms appear.
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.
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
Structured Label Content
Warnings and Precautions (34071-1)
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 ■ shock ■ asthma (wheezing)
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.
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take: ■ with other drugs containing acetaminophen ■ more than 8 caplets in 24 hours, which is the maximum daily amount ■ 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 ■ take more or for a longer time than directed ■ 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
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.
Uses
■ temporarily relieves minor aches and pains due to: ■ headache ■ muscular aches ■ a cold ■ arthritis ■ toothache ■ premenstrual and menstrual cramps
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
■ do not take more than 8 caplets in 24 hours
■ children under 12 years: ask a doctor
Other Information (Other information)
■ Store in a dry place at 15° – 30°C (59° – 86°F)
■ use by expiration date on package
Section 34088-5 (34088-5)
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 42229-5 (42229-5)
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
†CVS™ is not affiliated with the owner of the registered trademark Excedrin® Extra Strength Headache.
Distributed by:
CVS Pharmacy, Inc.
One CVS Drive
Woonsocket, RI 02895
© 2025 CVS/pharmacy
CVS.com® 1-800-SHOP CVS
Section 50565-1 (50565-1)
Keep out of reach of children.
Section 51727-6 (51727-6)
hypromellose, maltodextrin, microcrystalline cellulose, polydextrose, polyvinylpyrrolidone, pregelatinized starch, silica, starch, stearic acid, talc, titanium dioxide, triglycerides
Section 51945-4 (51945-4)
VALUE SIZE
CVS™
NDC 69842-541-17
Extra Strength HEADACHE RELIEF
Acetaminophen, 250 mg
Aspirin (NSAID), 250 mg
Caffeine, 65 mg
Pain Reliever, Pain Reliever Aid
Compare to Excedrin® Extra Strength Headache active ingredients†
300 CAPLETS
Section 55105-1 (55105-1)
Purpose
Pain reliever
Pain reliever
Pain reliever aid
Do Not Use (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.
Drug Facts
Active ingredients (in each caplet)
Acetaminophen 250 mg
Aspirin 250 mg (NSAID*)
Caffeine 65 mg
*nonsteroidal anti-inflammatory drug
Questions Or Comments? (Questions or comments?)
1-800-231-4670
Ask A Doctor Before Use If (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 have asthma
■ you are taking a diuretic
Stop Use and Ask A Doctor If (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 ■ have bloody or black stools ■ vomit blood
■ have stomach pain that does not get better
■ ringing in the ears or loss of hearing occurs
■ pain gets worse or lasts for more than 10 days
■ fever gets worse or lasts for more than 3 days
■ painful area is red or swollen
■ any new symptoms appear.
These could be signs of a serious condition.
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 If You Are (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
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Source: dailymed · Ingested: 2026-02-15T12:03:03.929848 · Updated: 2026-03-14T23:13:10.446567