MedPath

Naproxen Sodium

Premier Value 44-604

Approved
Approval ID

0ee710df-d284-4219-b914-81f8bf623abc

Product Type

HUMAN OTC DRUG LABEL

Effective Date

May 12, 2025

Manufacturers
FDA

Chain Drug Consortium

DUNS: 101668460

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Naproxen Sodium

PRODUCT DETAILS

NDC Product Code68016-676
Application NumberANDA204872
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateMay 12, 2025
Generic NameNaproxen Sodium

INGREDIENTS (11)

NAPROXEN SODIUMActive
Quantity: 220 mg in 1 1
Code: 9TN87S3A3C
Classification: ACTIB
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
FD&C BLUE NO. 2 ALUMINUM LAKEInactive
Code: 4AQJ3LG584
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 5/12/2025

Principal display panel

COMPARE TO THE ACTIVE INGREDIENT
** IN ALEVE
®**** CAPLETS**

Premier Value**®**

Naproxen Sodium Caplets
Naproxen Sodium Tablets, 220 mg
Pain Reliever/Fever Reducer**(NSAID)**

STRENGTH TO LAST 12 HOURS

100 Film Coated Caplets**
**CAPSULE-SHAPED TABLETS

actual
size

PV
INDEPENDENTLY TESTED
SATISFACTION GUARANTEED

TAMPER EVIDENT: DO NOT USE IF IMPRINTED
** SAFETY SEAL UNDER CAP IS BROKEN OR MISSING**

†This product is not manufactured or distributed by
Bayer HealthCare LLC, owner of the registered trademark
Aleve® Caplets.

50844 REV1221B60412

Distributed By:
** Pharmacy Value Alliance, LLC**
** 407 East Lancaster Avenue,**
** Wayne, PA 19087**

PV
INDEPENDENTLY TESTED
SATISFACTION GUARANTEED

If for any reason you are not satisfied with
** this product, please return it to the store**
** where purchased for a full refund.**

![Premier Value 44-604](/dailymed/image.cfm?name=premier- value-44-604-1.jpg&id=874723)

Premier Value 44-604

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 5/12/2025

Uses

  • temporarily relieves minor aches and pains due to:
    • headache
    • muscular aches
    • the common cold
    • toothache
    • backache
    • menstrual cramps
    • minor pain of arthritis
  • temporarily reduces fever

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 5/12/2025

Active ingredient (in each caplet)

Naproxen sodium 220 mg (naproxen 200 mg) (NSAID)*
*nonsteroidal anti-inflammatory drug

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 5/12/2025

Purpose

Pain reliever/fever reducer

WARNINGS SECTION

LOINC: 34071-1Updated: 5/12/2025

Warnings

Allergy alert: Naproxen sodium may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:

  • asthma (wheezing)
  • skin reddening
  • shock
  • blisters
  • rash
  • facial swelling
  • hives

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

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

  • 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 have problems or serious side effects from taking pain relievers or fever reducers
  • you are taking a diuretic

Ask a doctor or pharmacist before use if you are

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

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:
    • feel faint
    • vomit blood
    • have bloody or black stools
    • have stomach pain that does not get better
  • you have symptoms of heart problems or stroke:
    • leg swelling
    • chest pain
    • slurred speech
    • trouble breathing
    • weakness in one part or side of body
  • 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 at 20 weeks or later in 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.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 5/12/2025

Directions

*do not take more than directed *the smallest effective dose should be used

  • drink a full glass of water with each dose
  • adults and children 12 years and older
    • take 1 caplet every 8 to 12 hours while symptoms last
    • for the first dose you may take 2 caplets within the first hour
    • do not exceed 2 caplets in any 8- to 12-hour period
    • do not exceed 3 caplets in a 24-hour period
  • children under 12 years: ask a doctor

STORAGE AND HANDLING SECTION

LOINC: 44425-7Updated: 5/12/2025

Other information

*each caplet contains: sodium 20 mg

  • store at 20°-25°C (68°-77°F). Avoid high humidity and excessive heat above 40°C (104°F)
  • see end flap for expiration date and lot number

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 5/12/2025

Inactive ingredients

croscarmellose sodium, FD&C blue #2 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, talc, titanium dioxide

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 5/12/2025

Questions or comments?

Call 1-800-426-9391 8:30 AM-4:00 PM ET, Monday-Friday

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.

Naproxen Sodium - FDA Drug Approval Details