Drug Facts

Active ingredients (in each caplet)

Uses

for the temporary relief of occasional headache 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 ● asthma (wheezing) ● shock

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

● 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

● take more or for a longer time than directed

Do not use

● if you are allergic to aspirin or any other pain reliever/fever reducer

● in children under 12 years of age

● with any other product containing diphenhydramine, even one used on the skin

● if you have ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if

● 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

● a breathing problem such as emphysema or chronic bronchitis

● glaucoma

● trouble urinating due to an enlarged prostate gland

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 ● arthritis

● taking tranquilizers or sedatives

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

● 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

● pain gets worse or lasts more than 10 days

● redness or swelling is present

● new symptoms occur

● ringing in the ears or a loss of hearing occurs

● sleeplessness lasts for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness.

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.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

● do not exceed recommended dosage

● drink a full glass of water with each dose

● adults and children 12 years and over: take 2 caplets at bedtime, if needed, or as directed by a doctor

● children under 12 years: do not use

Other Information

● store at room temperature

● save carton for full directions and warnings

Inactive ingredients

anhydrous citric acid, carnauba wax, colloidal silicon dioxide, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, hypromellose, microcrystalline cellulose, pregelatinized starch, propylene glycol, shellac, titanium dioxide, zinc stearate

Questions or comments? 1-800-331-4536 (Mon-Fri 9AM – 5PM EST)