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CVS 44-674


Active ingredients (in each caplet)

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


Purpose

Pain relieverPain relieverNighttime sleep-aid


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:

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

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

Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you

  • hives
  • facial swelling
  • shock
  • asthma (wheezing)

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

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

Ask a doctor or pharmacist before use if you are taking

  • 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

When using this product

  • avoid alcoholic beverages
  • drowsiness may occur
  • do not drive a motor vehicle or operate machinery

Stop use and ask a doctor if

These could be signs of a serious condition.

  • an allergic reaction occurs. Seek medical help right away.
  • you experience any of the following signs of stomach bleeding:feel faintvomit bloodhave bloody or black stoolshave 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

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.


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

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