ALEVE Caplet / Capsule / Tablet Ref.[27537] Active ingredients: Naproxen

Source: Health Products and Food Branch (CA)  Revision Year: 2021 

Indications and clinical use

ALEVE Caplets, ALEVE Liquid Gels, and ALEVE Back and Body Pain (naproxen sodium)
are indicated for the reduction of fever and the treatment of pain:

  • ALEVE is clinically proven to relieve arthritis pain. ALEVE relieves the daily pain and stiffness of arthritis. ALEVE relieves morning stiffness and arthritis pain at rest, on passive motion, on weight bearing, pain experienced day or night due to arthritis
  • ALEVE helps relieve the night pain associated with arthritis
  • ALEVE relieves the pain of inflammation
  • ALEVE relieves the pain or stiffness of rheumatic or arthritic conditions
  • ALEVE relieves joint and body pain
  • ALEVE relieves muscular ache
  • ALEVE relieves the pain of muscle sprains and strains
  • ALEVE relieves backache
  • ALEVE relieves headache
  • ALEVE relieves migraine pain
  • ALEVE relieves the pain of menstrual cramps (dysmenorrhoea)
  • ALEVE relieves the pain of minor surgery
  • ALEVE relieves toothache
  • ALEVE relieves the pain of dental extractions
  • ALEVE relieves minor aches and pain associated with the common cold

Dosage and administration

Dosing Considerations

  • In self-medication, ALEVE should only be used for a short term treatment period of up to five days for pain and 3 days for fever. Otherwise a doctor should be consulted.
  • Each dose should be swallowed with a full glass of water and can be taken fasting or with meals and/or antacids. Absorption may be slightly delayed with meals.
  • If symptoms change, a doctor should be consulted.
  • The recommended dosage should be adhered to unless directed by a doctor.
  • ALEVE is as safe on the stomach as Tylenol Extra Strength 500 mg and Advil 200mg if the maximum daily dose and the recommended length of use for each product is not exceeded.
  • ALEVE provides non-prescription pain relief that lasts up to 12 hours with 1 pill.

Recommended Dose and Dosage Adjustment

Adults (12-65 years): 1 caplet/capsule every 8-12 hours. For individuals over 65 years, 1 caplet/capsule every 12 hours. Do not take more than 2 caplets/capsules in a 24 hour period. Drink a full glass of water with each dose.

Under 12 years: Children under 12 should not take this drug. The safety in pediatric use has not been established.

Overdosage

Significant overdose can be characterized by drowsiness, heartburn, indigestion, nausea and vomiting.A few patients have experienced convulsions but it is not clear if these were naproxen related. Some cases with acute, reversible renal failure have been described. It is not known what dose of the drug would be life-threatening. Should a patient ingest a large quantity of naproxen sodium the stomach may be emptied and usual supportive measures like administration of activated charcoal employed. Hemodialysis does not decrease the plasma concentration of naproxen because of the high degree of its protein binding. There is no specific antidote.

Storage and stability

ALEVE Caplets: Store at room temperature (15-30°C).

ALEVE Liquid Gels and ALEVE Back and Body Pain (Capsules): Store at 15-25°C.

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