5004-cvs

5004-cvs
SPL v6
SPL
SPL Set ID 6deb854f-863e-24ad-e053-2991aa0afb17
Route
oral
Published
Effective Date 2025-10-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
caffeine (65 mg) aspirin (250 mg) acetaminophen
Inactive Ingredients
microcrystalline cellulose povidone k30 starch, pregelatinized corn medium-chain triglycerides hypromelloses maltodextrin polydextrose silicon dioxide titanium dioxide stearic acid talc

Identifiers & Packaging

Pill Appearance
Imprint: 2793 Shape: oval Color: white Size: 17 mm Score: 1
Marketing Status
otc monograph drug active Since 2018-06-22

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


Advanced Ingredient Data


Raw Label Data

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