Naproxen Sodium
09b52dd4-0434-237c-e063-6294a90ab9b5
HUMAN OTC DRUG LABEL
May 23, 2025
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
Product Classification
Product Specifications
INGREDIENTS (10)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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 to12**
****Last 12 HoursHOURS
** 220 50**
** mg CAPLETS****†******
****** EACH**
Actual Size**†**Capsule-Shaped Tablets
****
INDICATIONS & USAGE SECTION
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
When using this product
- take with food or milk if stomach upset occurs
INACTIVE INGREDIENT SECTION
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
Naproxen Sodium Tablets, USP 220 mg
Drug Facts
OTC - ACTIVE INGREDIENT SECTION
Active ingredient (in each caplet)
Naproxen sodium USP 220 mg (naproxen 200 mg) (NSAID)*
*nonsteroidal anti-inflammatory drug
OTC - PURPOSE SECTION
Purposes
Pain reliever/fever reducer
OTC - QUESTIONS SECTION
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
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
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
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
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
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
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
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
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 |
|
Children under 12 years |
|
STORAGE AND HANDLING SECTION
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).