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Aleve Pm Generic Name & Formulations
Legal Class
OTC
General Description
Naproxen sodium 220mg, diphenhydramine HCl 25mg; caplets.
Pharmacological Class
NSAID + hypnotic (anticholinergic).
How Supplied
Caplets—20, 50, 80, 120
Manufacturer
Aleve Pm Indications
Indications
Relief of occasional sleeplessness when associated with minor aches and pains.
Aleve Pm Dosage and Administration
Adult
Take with fluids. 2 caplets at bedtime. Max 2 caplets/24hrs.
Children
<12yrs: not recommended.
Aleve Pm Contraindications
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).
Aleve Pm Boxed Warnings
Not Applicable
Aleve Pm Warnings/Precautions
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. 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 (esp. during ≥20 weeks): not recommended. Nursing mothers.
Aleve Pm Pharmacokinetics
See Literature
Aleve Pm Interactions
Interactions
Avoid concomitant other pain relievers. Naproxen may decrease effects of aspirin. 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.
Aleve Pm Adverse Reactions
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.
Aleve Pm Clinical Trials
See Literature
Aleve Pm Note
Not Applicable
Aleve Pm Patient Counseling
See Literature
