PAIN RELIEF- naproxen sodium tablet, film coated 
Gobrands, Inc

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Pain Relief

Naproxen Sodium

Drug Facts

Active Ingredient (in each tablet)

Naproxen Sodium 220 mg**

**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 a nonsteroidal anti-inflammatory drug (NSAID), which may cause severe stomach bleeding. The chance is higher if you:

Heart attack and stroke warning: NSAIDs, except aspirin increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer 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 you

  • 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, kidney disease, asthma, or had a stroke
  • you are taking a diuretic
  • you have problems or serious side effects from taking pain relievers or fever reducers

Ask a doctor or pharmacist before use if you are if you are

  • under a doctor's care for any serious condition
  • taking any other drug
  • taking aspirin for heart attack or stroke, because naproxen may decrease this benefit of aspirin

When using this product

  • take with food or milk if stomach upset occurs

Stop use and ask a doctor if

  • you experience any of the following signs of stomach bleeding: n feel faint n vomit blood
  • have bloody or black stools
  • have stomach pain that does not get better
  • you have symptoms of heart problems or stroke:
  • chest pain
  • trouble breathing
  • weakness in one part or side of body
  • slurred speech n leg swelling
  • 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

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

Microcrystalline cellulose, Starch, Sodium starch glycolate, povidone (K-30), stearic acid, purified water, hydroxy propyl methylcellulose, polyethylene glycol, titanium dioxide, FD&C Blue #2 aluminum lake

Questions or comments?

1-888-333-9792

PRINCIPAL DISPLAY PANEL

Compare to the active ingredient in Aleve


NDC 82501-1576-1

Good now

12 HOUR
Pain Relief
Naproxen Sodium Tablets, 220 mg

100 TABLETS

Pain Reliever + Fever Reducer (NSAID)

Naproxen label front

Naproxen label back

PAIN RELIEF 
naproxen sodium tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82501-1576
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NAPROXEN SODIUM (UNII: 9TN87S3A3C) (NAPROXEN - UNII:57Y76R9ATQ) NAPROXEN220 mg
Inactive Ingredients
Ingredient NameStrength
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
STARCH, POTATO (UNII: 8I089SAH3T)  
SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)  
POVIDONE K30 (UNII: U725QWY32X)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
METHYLCELLULOSE, UNSPECIFIED (UNII: Z944H5SN0H)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FD&C BLUE NO. 1 ALUMINUM LAKE (UNII: J9EQA3S2JM)  
Product Characteristics
ColorblueScoreno score
ShapeOVALSize12mm
FlavorImprint Code 220
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:82501-1576-1100 in 1 BOTTLE; Type 0: Not a Combination Product05/30/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09135305/30/2022
Labeler - Gobrands, Inc (057499049)

Revised: 12/2023
Document Id: 0c047e21-c3c8-1a6a-e063-6294a90a39c6
Set id: ae4bfa8c-ae41-4fcd-b584-872cc4d37683
Version: 4
Effective Time: 20231208
 
Gobrands, Inc