MedPath

Naproxen Sodium

Approved
Approval ID

09b52dd4-0434-237c-e063-6294a90ab9b5

Product Type

HUMAN OTC DRUG LABEL

Effective Date

May 23, 2025

Manufacturers
FDA

WALMART INC.

DUNS: 051957769

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 Code79903-231
Application NumberANDA205497
Product Classification
M
Marketing Category
C73584
G
Generic Name
Naproxen Sodium
Product Specifications
Route of AdministrationORAL
Effective DateMay 23, 2025
FDA Product Classification

INGREDIENTS (10)

NAPROXEN SODIUMActive
Quantity: 220 mg in 1 1
Code: 9TN87S3A3C
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
HYPROMELLOSE 2910 (5 MPA.S)Inactive
Code: R75537T0T4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3B
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 5/23/2025

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 220 mg (50 Tablets Carton Label)

NDC 79903-231-50
** equate****™******


** Compare**
** to Aleve****®******
** caplets**
active
** ingredient
********


** All Day**
** Pain Relief**


** Naproxen Sodium**
** Tablets USP,220 mg
** (NSAID)


** Pain Reliever/**
Fever Reducer
** Strength to
12**
****Last 12 HoursHOURS


** 220 50**
** mg CAPLETS****†******
****** EACH**
Actual Size**†**Capsule-Shaped Tablets



****PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 220 mg (100 Tablets Carton Label)

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 5/23/2025

Uses

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

OTC - WHEN USING SECTION

LOINC: 50567-7Updated: 5/23/2025

When using this product

  • take with food or milk if stomach upset occurs

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 5/23/2025

Inactive ingredients

colloidal silicon dioxide, FD&C blue #2 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, talc, and titanium dioxide

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 5/23/2025

Naproxen Sodium Tablets, USP 220 mg

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 5/23/2025

Active ingredient (in each caplet)

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

*nonsteroidal anti-inflammatory drug

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 5/23/2025

Purposes

Pain reliever/fever reducer

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 5/23/2025

Questions or comments?

1-888-287-1915


DISTRIBUTED BY:
****Walmart Inc.,
****Bentonville, AR 72716

PRODUCT OF INDIA

**This product is not manufactured or distributed by
Bayer HealthCare LLC, distributor of Aleve® Caplets.

WARNINGS SECTION

LOINC: 34071-1Updated: 5/23/2025

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.

OTC - DO NOT USE SECTION

LOINC: 50570-1Updated: 5/23/2025

Do not use

  • if you have ever had an allergic reaction to any other pain reliever/fever reducer
  • right before or after heart surgery

OTC - ASK DOCTOR SECTION

LOINC: 50569-3Updated: 5/23/2025

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

OTC - ASK DOCTOR/PHARMACIST SECTION

LOINC: 50568-5Updated: 5/23/2025

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

OTC - STOP USE SECTION

LOINC: 50566-9Updated: 5/23/2025

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

OTC - PREGNANCY OR BREAST FEEDING SECTION

LOINC: 53414-9Updated: 5/23/2025

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 5/23/2025

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 5/23/2025

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: 5/23/2025

Other information

*each caplet contains: sodium 20 mg

  • store at 20° to 25°C (68° to 77°F). Avoid high humidity and excessive heat above 40°C (104°F).

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Naproxen Sodium - FDA Drug Approval Details