Naproxen Sodium Tablet, Coated
FDA Label NDC 68196-255

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Sam's West Inc for the product Naproxen Sodium (NDC 68196-255). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient (in each tablet/caplet), purposes, uses, warnings, directions, other information, inactive ingredients, questions or comments?, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient (In Each Tablet/Caplet)

Naproxen sodium USP, 220 mg
(naproxen USP, 200 mg) (NSAID)

nonsteroidal anti-inflammatory drug

Purposes

Pain reliever/fever reducer

Uses

  • temporarily relieves minor aches and pains due to:
    • minor pain of arthritis
    • muscular aches
    • backache
    • menstrual cramps
    • headache
    • toothache
    • the common cold
    • temporarily reduces fever

Warnings

Directions

  • do not take more than directed
  • the smallest effective dose should be used
  • drink a full glass of water with each dose
    • Adults and children 12 years and older
    • take 1 tablet/caplet every 8 to 12 hours while symptoms last
    • for the first dose you may take 2 tablets/caplets within the first hour
    • do not exceed 2 tablets/caplets in any 8 to 12 hour period
    • do not exceed 3 tablets/caplets in a 24-hour period
    Children under 12 years
    • ask a doctor

Other Information

  • each tablet/caplet contains: sodium 20 mg
  • store at 20-25°C (68-77°F). Avoid high humidity and excessive heat above 40°C (104°F).

Inactive Ingredients

FD &C Blue # 2, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, talc, titanium dioxide

Questions Or Comments?

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