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Drug Facts


Active ingredients (in each caplet)

Acetaminophen 250 mg

Aspirin 250 mg (NSAID*)

Diphenhydramine citrate 38 mg

*nonsteroidal anti-inflammatory drug


Purposes

Pain Reliever

Pain Reliever

Nighttime 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: Acetaminophen may cause severe skin reactions. Symptoms may include:

If a skin reaction occurs, stop use and seek medical help right away.

Allergy alert: Aspirin may cause a severe allergic reaction which may include:

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

  • •skin reddening
  • •blisters
  • •rash

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

  • •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
  • •you have glaucoma
  • •you have a breathing problem such as emphysema or chronic bronchitis
  • •you have trouble urinating due to an enlarged prostate gland

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
  • •any product that contains aspirin, acetaminophen, or any other pain reliever/fever reducer
  • •sedatives or tranquilizers

When using this product

  • •drowsiness will occur
  • •avoid alcoholic drinks
  • •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 faint•vomit blood•have bloody or black stools•have stomach pain that does not get better
  • •sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness.
  • •pain gets worse or last for more than 10 days
  • •painful area is red or swollen
  • •ringing in the ears or a loss of hearing occurs
  • •any 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 overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.


Directions

  • •do not use more than directed
  • •do not use in children under 12 years of age
  • •adults and children 12 years of age 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

Other information

  • •each caplet contains: 75 mg calcium
  • •store at 20°-25°C (68°-77°F).
  • •close cap tightly after use.
  • •read all product information before using. Keep this box for important information.

Inactive ingredients

benzoic acid, calcium carbonate, FD&C blue no. 1 aluminum lake, ferric oxide yellow, hypromellose, low substituted hydroxypropyl cellulose, magnesium stearate, maltodextrin, medium-chain triglycerides, polydextrose, polysorbate 80, povidone, pregelatinized corn starch, silicified microcrystalline cellulose, stearic acid, talc, titanium dioxide, zinc stearate