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ALEVE PM
Sleep-wake disorders
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Drug Name:

ALEVE PM OTC

Generic Name and Formulations:
Naproxen sodium 220mg, diphenhydramine HCl 25mg; caplets.

Company:
Bayer Healthcare Pharmaceuticals Inc.

Therapeutic Use:

Indications for ALEVE PM:

Relief of occasional sleeplessness when associated with minor aches and pains.

Adult:

Take with fluids. 2 caplets at bedtime. Max 2 caplets/24hrs.

Children:

<12yrs: not recommended.

Contraindications:

Aspirin allergy. Unless sufficient time for a full night's sleep. Immediately before or after cardiac surgery. Sleeplessness without pain. Concomitant with other diphenhydramine-containing products (including topicals).

Warnings/Precautions:

Increased risk of severe stomach bleeding (esp. ≥60yrs old). History of GI disorders (eg, heartburn, bleeding ulcers). Respiratory disorders (eg, emphysema, bronchitis). Increased risk of heart attack or failure, and stroke (may be fatal). Hypertension. Heart disease. Recent stroke. Liver cirrhosis. Renal disease. Asthma. Glaucoma. GI or urinary obstruction. Reevaluate if pain worsens or lasts >10 days or sleeplessness persists continuously >2 weeks. Elderly. Pregnancy (avoid during 3rd trimester). Nursing mothers.

Pharmacological Class:

NSAID + hypnotic (anticholinergic).

Interactions:

Avoid aspirin or other pain relievers. Increased risk of GI bleed with anticoagulants, corticosteroids, other OTC or Rx NSAID-containing products (eg, ibuprofen, naproxen, others), ≥3 alcoholic drinks/day, or prolonged use. Caution with diuretics. Additive effects with other antihistamines, anticholinergics, sedatives, tranquilizers, or any other sleep-aid.

Adverse Reactions:

Drowsiness, GI upset/bleed, vomit blood, feel faint, rash, redness, difficulty swallowing, symptoms of heart problems or stroke (eg, trouble breathing, chest pain, weakness, slurred speech, leg swelling), allergic reactions; discontinue if occur.

How Supplied:

Caplets—20, 40, 80, 160

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