Naproxen Sodium description, usages, side effects, indications, overdosage, supplying and lots more!

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Naproxen Sodium

Rugby Laboratories Inc

RugbyNaproxen Sodium 220 mgPain Reliever/ Fever Reducer (NSAID)




FULL PRESCRIBING INFORMATION

(in each caplet)

Naproxen sodium 220 mg

(naproxen 200 mg) (NSAID)*

*nonsteroidal anti-inflammatory drug

Pain reliever/fever reducer

  • 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

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

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

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:

  • are age 60 or older
  • have had stomach ulcers or bleeding problems
  • take a blood thinning (anticoagulant) or steroid drug
  • take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
  • have 3 or more alcoholic drinks every day while using this product
  • take more or for a longer time than directed
  • if you have ever had an allergic reaction to any other pain reliever/fever reducer
  • right before or after heart surgery
  • the stomach bleeding problems apply to you
  • you have a history of stomach problems, such as heartburn
  • you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
  • you are taking a diuretic
  • you have problems or serious side effects from taking pain relievers or fever reducers
  • you have asthma
  • under a doctor’s care for any serious condition
  • taking any other drug
  • take with food or milk if stomach upset occurs
  • the risk of heart attack or stroke may increase if you use more than directed or for longer than directed
  • you experience any of the following signs of stomach bleeding
  • feel faint
  • vomit blood
  • have bloody or black stools
  • have stomach pain that does not get better
  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days
  • you have difficulty swallowing
  • it feels like the pill is stuck in your throat
  • redness or swelling is present in the painful area
  • any new symptoms appear

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.

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

  • 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 caplet every 8 to 12 hours while symptoms last
  • for the first dose you may take 2 caplets within the first hour
  • do not exceed 2 caplets in any 8- to 12-hour period
  • do not exceed 3 caplets in a 24-hour period
 Children under 12 years  
  • ask a doctor
  • each caplet contains: sodium 20 mg
  • store at 20 to 25°C (68 to77°F). Avoid high humidity and excessive heat above 40°C (104°F)
  • read all warnings and directions before use. Keep carton.
  • do not use if inner seal under bottle cap imprinted wiht "Sealed for Your Protection" is broken or missing

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

Call 1-800-645-2158  9am–5pm ET, Monday-Friday

Compare to Active ingredient in Aleve®**

**Rugby Laboratories, Inc. is not affiliated wiht the owner of the trademark Aleve®.

Rugby Naproxen Sodium 220 mg is distributed by Rugby Laboratories, Inc.

Rugby® Duluth, Georgia  30097

www.rugbylaboratories.com

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

 Naproxen Sodium

Naproxen Sodium 220 mg

Naproxen Sodium

Naproxen Sodium TABLET

Product Information

Product Type Human otc drug label Item Code (Source) NDC:0536-4113(NDC:53746-192)
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
naproxen sodium NAPROXEN 220 mg

Inactive Ingredients

Ingredient Name Strength
CROSCARMELLOSE SODIUM
FD&C BLUE NO. 2
POLYETHYLENE GLYCOLS
MAGNESIUM STEARATE
POLYVINYL ALCOHOL
POVIDONES
STARCH, CORN
talc
titanium dioxide

Product Characteristics

Color Size Imprint Code Shape
BLUE 13 mm I7 CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0536-4113-06 50 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA079096 2009-11-25


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Be sure to consult your doctor before taking any medication!
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