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Naproxen Sodium Tablets, USP Pain Reliever/ Fever Reducer (NSAID) 220 mg


Compared to the active ingredient of Aleve® †

Drug Facts


ACTIVE INGREDIENT

(in each Tablet)

Naproxen sodium 220 mg

(naproxen 200 mg) (NSAID)*

*nonsteroidal anti-inflammatory drug


PURPOSE

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

Allergy alert:  Naproxen sodium may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:

If an allergic reaction occurs, stop use and seek medical help right away.

Stomach bleeding warning: This product contains an (NSAID), which may cause severe stomach bleeding. The chance is higher if you:

Do not use

Ask a doctor before use if you have

Ask a doctor or pharmacist before use if you are

When using this product

Stop use and ask a doctor if

If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use naproxen sodium 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.

  • hives
  • facial swelling
  • asthma (wheezing)
  • shock
  • skin reddening
  • rash
  • blisters

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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


INACTIVE INGREDIENT SECTION

croscarmellose sodium, FD&C Blue #2, macrogol, magnesium stearate, polyvinyl alcohol, povidone, pregelatinized starch, talc and titanium dioxide.


DIRECTIONS

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

Other information

  • each tablet contains: sodium 20 mg
  • store at 20 to 25°C (68 to77°F). Avoid high humidity and excessive heat above 40°C (104°F)

Distributed by:

Amneal Pharmaceuticals

Glasgow, KY 42141

Relabeling of "Additional barcode label" by:

Physicians Total Care, Inc.Tulsa, OK      74146


†This product is not manufactured or distributed by Bayer Healthcare, LLC., distributor of Aleve®

Rev. 06-2010