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Naproxen Sodium (naproxen sodium - naproxen sodium 220 mg oral tablet) Dailymed

  1. Human OTC
  2. Archived
  3. TOP CARE (Topco Associates LLC)

Generic: naproxen sodium

Naproxen Sodium tablet - (naproxen sodium - naproxen sodium 220 mg oral tablet) image
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IMPRINT: 220     SHAPE: oval
    COLOR: blue

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naproxen sodium - naproxen sodium 220 mg oral tablet - 220 oval blue

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Active Ingredient (in Each Caplet)


Naproxen sodium 220 mg

(naproxen 200 mg) (NSAID)*

*nonsteroidal anti-inflammatory drug

Purposes


Pain reliever/fever reducer

Uses

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

Warnings


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
  • bulers

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
  • have 3 or more alcoholic drinks every day while using this product
  • take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
  • take more or for a longer time than directed

Do not use

  • if you have ever had an allergic reaction to any other pain reliever/fever reducer
  • right before or after heart surgery

Ask a doctor before use if

  • the stomach bleeding warning applies 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 have problems or serious side effects from taking pain relievers or fever reducers
  • you have asthma
  • you are taking a diuretic

Ask a doctor or pharmacist before use if you are

  • under a doctor’s care for any serious condition
  • taking any other drug

When using this product

  • 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

Stop use and ask a doctor if

  • you experience any of the following signs of stomach bleeding:
    • feel faint
    • have bloody or black stools
    • vomit blood
    • 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
  • redness or swelling is present in the painful area
  • any new symptoms appear
  • you have difficulty swallowing
  • it feels like the pill is stuck in your throat

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.

Keep out of reach of children.


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

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 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

Other Information

  • each caplet contains: sodium 20 mg
  • store at 20º to 25ºC (68º to 77ºF). Avoid high humidity and excessive heat above 40ºC (104ºF).
  • read all warnings and directions before use. Keep carton.

Inactive Ingredients


FD&C blue #2 aluminum lake, hypromellose 2910, maize starch, microcrystalline cellulose, polyethylene glycol, povidone k-30, sodium starch glycolate, stearic acid, titanium dioxide

Questions Or Comments?


Call toll free 1-888-423-0139

Principal Display Panel


NON-PRESCRIPTION STRENGTH

All Day Pain Relief

NAPROXEN SODIUM TABLETS/ 220 mg EACH
  • Pain Reliever/ Fever Reducer (NSAID)
  • Strength to Last 12 Hours

Caplets

COMPARE TO ALEVE® active ingredient†

†This product is not manufactured or distributed by Bayer Healthcare, LLC., owner of the registered trademark Aleve®.

DO NOT USE IF INNER SEAL UNDER BOTTLE CAP IMPRINTED WITH "SEALED FOR YOUR PROTECTION" IS BROKEN OR MISSING.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

DISTRIBUTED BY TOPCO ASSOCIATED LLC

ELK GROVE VILLAGE, IL 60007

topcare@topco.com

Product Label

Top Care All Day Pain Relief Caplets

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"This product uses publicly available data from the U.S. National Library of Medicine (NLM), National Institutes of Health, Department of Health and Human Services; NLM is not responsible for the product and does not endorse or recommend this or any other product."

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