CLEAR CHOICE NAPROXEN SODIUM- naproxen sodium tablet

Clear Choice Naproxen Sodium by

Drug Labeling and Warnings

Clear Choice Naproxen Sodium by is a Otc medication manufactured, distributed, or labeled by Athlete's Needs Inc, Allegiant Health. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

CLEAR CHOICE NAPROXEN SODIUM 
naproxen sodium tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53185-004
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
NAPROXEN SODIUM (UNII: 9TN87S3A3C) (NAPROXEN - UNII:57Y76R9ATQ)	NAPROXEN SODIUM	220 mg

Inactive Ingredients
Ingredient Name	Strength
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)
POLYVINYL ALCOHOL (UNII: 532B59J990)
POVIDONE (UNII: FZ989GH94E)
STARCH, CORN (UNII: O8232NY3SJ)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	blue (Light Blue)	Score	no score
Shape	ROUND	Size	9mm
Flavor		Imprint Code	141
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53185-004-00	1 in 1 CARTON	05/06/2013
1		50 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA079096	05/06/2013

Labeler - Athlete's Needs Inc (619703945)

Establishment
Name	Address	ID/FEI	Business Operations
Allegiant Health		079501930	manufacture(53185-004)