MedPath

Naproxen Sodium

1144-QCH-2025-0520

Approved
Approval ID

84b9e9a4-b805-420e-83be-ebe98776d1ee

Product Type

HUMAN OTC DRUG LABEL

Effective Date

May 20, 2025

Manufacturers
FDA

CHAIN DRUG MARKETING ASSOCIATION, INC.

DUNS: 011920774

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

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code83324-109
Application NumberANDA079096
Product Classification
M
Marketing Category
C73584
G
Generic Name
NAPROXEN SODIUM
Product Specifications
Route of AdministrationORAL
Effective DateMay 20, 2025
FDA Product Classification

INGREDIENTS (10)

CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYVINYL ALCOHOLInactive
Code: 532B59J990
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
STARCH, PREGELATINIZED CORNInactive
Code: O8232NY3SJ
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
NAPROXEN SODIUMActive
Quantity: 220 mg in 1 1
Code: 9TN87S3A3C
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 5/20/2025

PRINCIPAL DISPLAY PANEL

QUALITY CHOICE®

NDC 83324-109-50

†Compare to the Active ingredient in Aleve®

Naproxen Sodium

Tablets, 220 mg

Pain Reliever/Fever Reducer

(NSAID)

Strength to Last 12 Hours

Actual Size

50 TABLETS

image description

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 1/4/2013

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

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 1/4/2013

Inactive ingredients

croscarmellose sodium, FD&C blue #2, macrogol, magnesium stearate, polyvinyl alcohol, povidone, pregelatinized starch, talc, titanium dioxide

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 5/20/2025

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 5/15/2025

Active ingredient (in each caplet)

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

*nonsteroidal anti-inflammatory drug

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 5/15/2025

Purposes

Pain reliever/fever reducer

WARNINGS SECTION

LOINC: 34071-1Updated: 5/15/2025

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

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 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

  • 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:
■ chest pain
■ trouble breathing
■ weakness in one part or side of body
■ slurred speech
■ 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 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. (1-800-822-1222)

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 5/15/2025

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: 5/15/2025

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).

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Naproxen Sodium - FDA Drug Approval Details