Cvs 44-674-delisted

Cvs 44-674-delisted
SPL v13
SPL
SPL Set ID ddd78b28-6e10-4708-bed1-8aea087b3d82
Route
ORAL
Published
Effective Date 2026-02-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (250 mg) Aspirin (38 mg) Diphenhydramine
Inactive Ingredients
Starch, Corn Crospovidone, Unspecified Fd&c Blue No. 1 Aluminum Lake Hypromellose, Unspecified Maltodextrin Medium-chain Triglycerides Microcrystalline Cellulose Polydextrose Povidone, Unspecified Sodium Lauryl Sulfate Sodium Starch Glycolate Type A Potato Sodium Sulfate Stearic Acid Talc Titanium Dioxide Ferric Oxide Yellow Zinc Stearate

Identifiers & Packaging

Pill Appearance
Imprint: 674 Shape: oval Color: blue Size: 17 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Completed Since 2016-08-31 Until 2027-06-30

Description

Acetaminophen 250 mg Aspirin 250 mg (NSAID)* Diphenhydramine citrate 38 mg *nonsteroidal anti-inflammatory drug

Purpose

Pain reliever Pain reliever Nighttime sleep-aid


Medication Information

Purpose

Pain reliever

Pain reliever

Nighttime sleep-aid

Description

Acetaminophen 250 mg Aspirin 250 mg (NSAID)* Diphenhydramine citrate 38 mg *nonsteroidal anti-inflammatory drug

Uses

for the temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness

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
  • shock
  • asthma (wheezing)

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

  • blisters
  • rash
  • skin reddening

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

  • are age 60 or older
  • take more or for a longer time than directed
  • take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]
  • have had stomach ulcers or bleeding problems
  • take a blood thinning (anticoagulant) or steroid drug
  • have 3 or more alcoholic drinks every day while using this product
Directions
  • do not take more than directed
  • adults and children 12 years and over: take 2 caplets at bedtime, with a full glass of water
  • do not take more than 2 caplets in 24 hours, unless directed by a doctor
  • children under 12 years: 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.
  • with any other product containing diphenhydramine, even one used on skin
  • in children under 12 years of age
Other Information
  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • see end flap for expiration date and lot number
Inactive Ingredients

corn starch, crospovidone, FD&C blue #1 aluminum lake, hypromellose, maltodextrin, medium chain triglycerides, microcrystalline cellulose, polydextrose, povidone, sodium lauryl sulfate, sodium starch glycolate, sodium sulfate, stearic acid, talc, titanium dioxide, yellow iron oxide, zinc stearate

Questions Or Comments?

1-800-426-9391

Principal Display Panel

♥︎CVSHealth®

Compare to the active ingredients

in Excedrin® PM Headache

Caplets

Pain Relief PM

ACETAMINOPHEN,
250 mg

ASPIRIN (NSAID), 250 mg

DIPHENHYDRAMINE CITRATE, 38 mg

Pain reliever, Nighttime sleep-aid

• Non-habit forming

• For pain with sleeplessness

100 CAPLETS

Actual Size

Package Contains One Bottle

TAMPER EVIDENT: DO NOT USE IF IMPRINTED

SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

This product is not manufactured or distributed by

GSK Consumer Healthcare SARL, owner of the registered

trademark Excedrin® PM Headache.

50844      REV1121A67412

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

© 2022 CVS/pharmacy CVS.com® 1-800-SHOP CVS V-11112

CVS 44-674
When Using This Product
  • avoid alcoholic beverages
  • drowsiness may occur
  • do not drive a motor vehicle or operate machinery
Ask A Doctor Before Use If
  • stomach bleeding warning applies to you
  • you have a history of stomach problems, such as heartburn
  • you have difficulty in urination due to enlargement of the prostate gland
  • you have liver disease
  • you have a breathing problem such as emphysema or chronic bronchitis
  • you are taking a diuretic
  • you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
  • you have glaucoma
  • you have asthma
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 a loss of hearing occurs
  • sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness.
  • pain gets worse or lasts for more than 10 days
  • redness or swelling is present
  • 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 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.

Keep Out of Reach of Children.

In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Active Ingredients (in Each Caplet)

Acetaminophen 250 mg

Aspirin 250 mg (NSAID)*

Diphenhydramine citrate 38 mg

*nonsteroidal anti-inflammatory drug

Ask A Doctor Or Pharmacist Before Use If You Are
  • a prescription drug for:
    • diabetes
    • gout
    • arthritis
  • any other drug, or are under a doctor’s care for any serious condition
  • sedatives or tranquilizers
  • any product that contains aspirin, acetaminophen, or any other pain reliever/fever reducer

Structured Label Content

Uses

for the temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness

Purpose

Pain reliever

Pain reliever

Nighttime sleep-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
  • shock
  • asthma (wheezing)

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

  • blisters
  • rash
  • skin reddening

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

  • are age 60 or older
  • take more or for a longer time than directed
  • take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]
  • have had stomach ulcers or bleeding problems
  • take a blood thinning (anticoagulant) or steroid drug
  • have 3 or more alcoholic drinks every day while using this product
Directions
  • do not take more than directed
  • adults and children 12 years and over: take 2 caplets at bedtime, with a full glass of water
  • do not take more than 2 caplets in 24 hours, unless directed by a doctor
  • children under 12 years: do not use
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.
  • with any other product containing diphenhydramine, even one used on skin
  • in children under 12 years of age
Other Information (Other information)
  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • see end flap for expiration date and lot number
Inactive Ingredients (Inactive ingredients)

corn starch, crospovidone, FD&C blue #1 aluminum lake, hypromellose, maltodextrin, medium chain triglycerides, microcrystalline cellulose, polydextrose, povidone, sodium lauryl sulfate, sodium starch glycolate, sodium sulfate, stearic acid, talc, titanium dioxide, yellow iron oxide, zinc stearate

Questions Or Comments? (Questions or comments?)

1-800-426-9391

Principal Display Panel

♥︎CVSHealth®

Compare to the active ingredients

in Excedrin® PM Headache

Caplets

Pain Relief PM

ACETAMINOPHEN,
250 mg

ASPIRIN (NSAID), 250 mg

DIPHENHYDRAMINE CITRATE, 38 mg

Pain reliever, Nighttime sleep-aid

• Non-habit forming

• For pain with sleeplessness

100 CAPLETS

Actual Size

Package Contains One Bottle

TAMPER EVIDENT: DO NOT USE IF IMPRINTED

SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

This product is not manufactured or distributed by

GSK Consumer Healthcare SARL, owner of the registered

trademark Excedrin® PM Headache.

50844      REV1121A67412

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

© 2022 CVS/pharmacy CVS.com® 1-800-SHOP CVS V-11112

CVS 44-674
When Using This Product (When using this product)
  • avoid alcoholic beverages
  • drowsiness may occur
  • do not drive a motor vehicle or operate machinery
Ask A Doctor Before Use If (Ask a doctor before use if)
  • stomach bleeding warning applies to you
  • you have a history of stomach problems, such as heartburn
  • you have difficulty in urination due to enlargement of the prostate gland
  • you have liver disease
  • you have a breathing problem such as emphysema or chronic bronchitis
  • you are taking a diuretic
  • you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
  • you have glaucoma
  • you have asthma
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
    • vomit blood
    • have bloody or black stools
    • have stomach pain that does not get better
  • ringing in the ears or a loss of hearing occurs
  • sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness.
  • pain gets worse or lasts for more than 10 days
  • redness or swelling is present
  • new symptoms occur

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 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.

Keep Out of Reach of Children. (Keep out of reach of children.)

In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Active Ingredients (in Each Caplet) (Active ingredients (in each caplet))

Acetaminophen 250 mg

Aspirin 250 mg (NSAID)*

Diphenhydramine citrate 38 mg

*nonsteroidal anti-inflammatory drug

Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)
  • a prescription drug for:
    • diabetes
    • gout
    • arthritis
  • any other drug, or are under a doctor’s care for any serious condition
  • sedatives or tranquilizers
  • any product that contains aspirin, acetaminophen, or any other pain reliever/fever reducer

Advanced Ingredient Data


Raw Label Data

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