ALL DAY PAIN RELIEF- naproxen sodium tablet 
Rebel Distributors Corp

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All Day Pain Relief 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

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

  • 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 right away. (1-800-222-1222)

Directions

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

Inactive ingredients

FD&C blue no. 2 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, talc, titanium dioxide

Questions or comments?

1-800-719-9260

Principal Display Panel

Strength to Last 12 Hours

See New Warnings Information

All Day Pain Relief

Naproxen Sodium Tablets, 220 mg

Pain Reliever & Fever Reducer (NSAID)

Actual Size

Compare to active ingredient of Aleve® Tablets

Naproxen Sodium 220mg

ALL DAY PAIN RELIEF 
naproxen sodium tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:42254-230(NDC:0113-9490)
Route of Administration ORAL DEA Schedule     
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)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
POVIDONES (UNII: FZ989GH94E)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
Color BLUE (Light Blue) Score no score
Shape ROUND Size 10mm
Flavor Imprint Code L490
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:42254-230-14 14 in 1 BOTTLE
2 NDC:42254-230-20 20 in 1 BOTTLE
3 NDC:42254-230-30 30 in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA074661 01/14/1997
Labeler - Rebel Distributors Corp (118802834)
Registrant - PSS World Medical, Inc. (101822862)
Establishment
Name Address ID/FEI Business Operations
PSS World Medical, Inc. 791528623 REPACK(42254-230)
Establishment
Name Address ID/FEI Business Operations
STAT RX USA LLC 786036330 REPACK(42254-230)
Establishment
Name Address ID/FEI Business Operations
Dispensing Solutions, Inc. 066070785 RELABEL(42254-230) , REPACK(42254-230)
Establishment
Name Address ID/FEI Business Operations
SCRIPT PAK 964420108 RELABEL(42254-230) , REPACK(42254-230)
Establishment
Name Address ID/FEI Business Operations
Keltman Pharmaceuticals, Inc. 362861077 REPACK(42254-230)
Establishment
Name Address ID/FEI Business Operations
Rebel Distirbutors Corp. 118802834 RELABEL(42254-230) , REPACK(42254-230)

Revised: 5/2012
Document Id: c863fdd7-5919-4ee0-b2d1-952c5faf3a09
Set id: c863fdd7-5919-4ee0-b2d1-952c5faf3a09
Version: 1
Effective Time: 20120529
 
Rebel Distributors Corp