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Clear Choice Naproxen Sodium

Dosage form: tablet
Ingredients: NAPROXEN SODIUM 220mg
Labeler: Athlete's Needs Inc
NDC Code: 53185-004

Clear Choice Naproxen Sodium

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:

  • 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

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 are taking a diuretic
  • you have asthma

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
  • 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
  • you develop heartburn
  • redness or swelling is present in the painful area
  • any new symptoms appear

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 immediately.

Directions
  • do not take more than directed
  • the smallest effective dose should be used
  • do not take longer than 10 days, unless directed by a doctor (see Warnings)
  • drink a full glass of water with each dose

Adults and

children

12 years

and older
  • take 1 tablet every 8 to 12 hours while symptoms last
  • for the first dose you may take 2 tablets within the first hour
  • do not exceed 2 tablets in any 8- to 12-hour period
  • do not exceed 3 tablets in a 24-hour period

Children

under 12

years
  • ask a doctor

Other information
  • each tablet contains: sodium 20 mg
  • store at 20-25°C (68-77°F). Avoid high humidity and excessive heat above 40°C (104°F).
  • Do not use if tamper evident seal under bottle cap is broken or missing.

Inactive ingredients

croscarmellose, FD&C blue no. 2, macrogol, magnesium stearate, polyvinyl alcohol, povidone, talc, titanium dioxide.

Questions or comments?

1-800-326-8147

Principal Display Panel

Clear Choice

Naproxen

Sodium

(NSAID)

Modern Pain Medicine

PAIN AND FEVER RELIEF

CONTAINS NO ASPIRIN

CAFFEINE FREE

Compare to Aleve®

See New Warnings Information

50 tablet

220 mg Each

Manufactured for A.N.I. Toledo OH 436253

CLEAR CHOICE NAPROXEN SODIUM 
naproxen sodium tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53185-004
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NAPROXEN SODIUM (NAPROXEN) NAPROXEN SODIUM220 mg
Inactive Ingredients
Ingredient NameStrength
FD&C BLUE NO. 2 
CROSCARMELLOSE SODIUM 
MAGNESIUM STEARATE 
POLYETHYLENE GLYCOLS 
POLYVINYL ALCOHOL 
POVIDONE 
STARCH, CORN 
TALC 
TITANIUM DIOXIDE 
Product Characteristics
Colorblue (Light Blue) Scoreno score
ShapeROUNDSize9mm
FlavorImprint Code141
Contains    
Packaging
#Item CodePackage Description
1NDC:53185-004-001 BOTTLE in 1 CARTON
150 TABLET in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07909605/06/2013
Labeler - Athlete's Needs Inc (619703945)
Establishment
NameAddressID/FEIOperations
Allegiant Health079501930manufacture(53185-004)

 
Athlete's Needs Inc

Medically reviewed on Aug 24, 2017

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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