NAPROXEN SODIUM- naproxen sodium capsule, liquid filled 
PuraCap Pharmaceutical LLC

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Naproxen Sodium Capsules, 220 mg

Drug Facts

Active ingredient (in each capsule)

Naproxen sodium 220 mg (naproxen 200 mg) (NSAID)*    

*nonsteroidal anti-inflammatory drug

Purposes

Pain reliever/fever reducer

Purposes

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:

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

Ask a doctor before use if

Ask a doctor or pharmacist before use if you are

When using this product

Stop use and ask a doctor if

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

adults and children 12 years and older:
  • take 1 capsule every 8 to 12 hours while symptoms last
  • for the first dose you may take 2 capsules within the first hour
  • do not exceed 2 capsules in any 8- to 12-hour period
  • do not exceed 3 capsules in a 24-hour period
children under 12 years:
  • ask a doctor

Other information

Inactive ingredients

FD&C blue#1, gelatin, glycerin, lactic acid, lecithin, light mineral oil, n-butyl alcohol, polyethylene glycol, povidone, propylene glycol, purified water, shellac glaze, sorbitol sorbitan solution, titanium dioxide, white ink

Questions or comments?

Call toll free: 1-855-215-8180

PRINCIPAL DISPLAY PANEL

Naproxen Sodium Capsules, 220 mg (NSAID)

pain reliever/fever reducer

NDC 51013-137-15

20 LIQUID GELS (LIQUID FILLED CAPSULES)

NAPROXEN-20CT-carton

NAPROXEN-20CT-bottle-front

NAPROXEN-20CT-bottle-back

PRINCIPAL DISPLAY PANEL

Naproxen Sodium Capsules, 220 mg (NSAID)

pain reliever/fever reducer

NDC 51013-137-28

160 LIQUID GELS (LIQUID FILLED CAPSULES)

NAPROXEN-160CT-LABEL-carton

NAPROXEN-160CT-LABEL-bottle

NAPROXEN SODIUM 
naproxen sodium capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51013-137
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NAPROXEN SODIUM (UNII: 9TN87S3A3C) (NAPROXEN - UNII:57Y76R9ATQ) NAPROXEN220 mg
Inactive Ingredients
Ingredient NameStrength
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
LACTIC ACID (UNII: 33X04XA5AT)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
LIGHT MINERAL OIL (UNII: N6K5787QVP)  
BUTYL ALCOHOL (UNII: 8PJ61P6TS3)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POVIDONE (UNII: FZ989GH94E)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SHELLAC (UNII: 46N107B71O)  
SORBITOL (UNII: 506T60A25R)  
SORBITAN (UNII: 6O92ICV9RU)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
Colorblue (CLEAR) Scoreno score
Shapecapsule (OBLONG) Size20mm
FlavorImprint Code PC19
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51013-137-151 in 1 CARTON03/20/2018
120 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:51013-137-281 in 1 CARTON03/20/2018
2160 in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:51013-137-60160 in 1 BOTTLE; Type 0: Not a Combination Product03/20/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20836303/20/2018
Labeler - PuraCap Pharmaceutical LLC (962106329)
Establishment
NameAddressID/FEIBusiness Operations
Humanwell PuraCap Pharmaceuticals (Wuhan) Co., Ltd421293287manufacture(51013-137) , analysis(51013-137)

Revised: 12/2019
Document Id: 9a223804-f229-442b-85a9-7f0f8fd74ba1
Set id: fc865e81-164c-48e9-8fb9-6fc27d1c33cf
Version: 4
Effective Time: 20191210
 
PuraCap Pharmaceutical LLC