Perrigo Naproxen Sodium Drug Facts

Manufacturer
L. Perrigo Company
Effective date
2026-05-11
Label type
HUMAN OTC DRUG LABEL
Version
10
Source
full-release
Hydrated at
2026-06-01 01:58:38

Key Label Information#

Active Ingredients And Purpose

Active ingredient (in each caplet)

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

Purposes

Pain reliever/fever reducer

Uses

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

Warnings

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.

Directions And Dosage

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

Other Label Information

Other information

• each caplet contains: sodium 22 mg • store at 20-25°C (68-77°F). Avoid high humidity and excessive heat above 40°C (104°F).

Inactive ingredients

FD&C blue no. 2 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, talc, titanium dioxide

Questions or comments?

1-800-719-9260

Principal Display Panel

GOODSENSE ® Strength To Last 12 Hours Naproxen Sodium Tablets, 220 mg Pain Reliever Fever Reducer (NSAID) Actual Size Compare to active ingredient of Aleve ® Caplets 50 Caplets** **Capsule-Shaped Tablets

Label Images#

goodsense-naproxen-sodium-carton-image
goodsense-naproxen-sodium-carton-image

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
849574naproxen sodium 220 MG Oral TabletPSN10
849574naproxen sodium 220 MG Oral TabletSCD10
849574naproxen sodium 220 MG (as naproxen 200 MG) Oral TabletSY10

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
NAPROXEN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20191108

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fef6ad89-235f-4274-ba49-a8e53642473eProduct name220250225
87fed3e6-8fba-48ef-96b0-3a7fb54b96ffProduct name320230306
b5fdaaec-7251-4da6-9cb2-4e9e76939ec8Product name120200623
e76dbbc1-775d-722c-08ff-ed45e8a80defProduct name320181002
6f4f4521-fd56-1ae6-888b-3b021bd75c7cProduct name120140508
ce67e27d-1d21-5465-4409-b0662dd99d4dProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0113-4368-00Good Sense Naproxen Sodium200 in 1 BOTTLETABLET, FILM COATED20010
0113-4368-62Good Sense Naproxen Sodium24 in 1 BOTTLETABLET, FILM COATED2410
0113-4368-62Good Sense Naproxen Sodium1 in 1 CARTONTABLET, FILM COATED110
0113-4368-71Good Sense Naproxen Sodium50 in 1 BOTTLETABLET, FILM COATED5010
0113-4368-71Good Sense Naproxen Sodium1 in 1 CARTONTABLET, FILM COATED110
0113-4368-75Good Sense Naproxen Sodium1 in 1 CARTONTABLET, FILM COATED110
0113-4368-75Good Sense Naproxen Sodium90 in 1 BOTTLETABLET, FILM COATED9010
0113-4368-76Good Sense Naproxen Sodium1 in 1 CARTONTABLET, FILM COATED110
0113-4368-76Good Sense Naproxen Sodium120 in 1 BOTTLETABLET, FILM COATED12010
0113-4368-78Good Sense Naproxen Sodium1 in 1 CARTONTABLET, FILM COATED110
0113-4368-78Good Sense Naproxen Sodium100 in 1 BOTTLETABLET, FILM COATED10010
0113-4368-79Good Sense Naproxen Sodium400 in 1 BOTTLETABLET, FILM COATED40010
0113-4368-82Good Sense Naproxen Sodium1 in 1 CARTONTABLET, FILM COATED110

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0113-4368-62EA - Each0113-4368bc67d066-2a1e-4806-a7c1-e232b732e93b12018-02-20
0113-4368-71EA - Each0113-4368993338e5-109e-4ef6-9be0-b5f443412b5712018-02-20
0113-4368-76EA - Each0113-436844440010-53b4-4de7-9f66-fda678f65a3512024-02-14
0113-4368-78EA - Each0113-4368e8dafb0f-462d-4fc5-bfb9-c6567df41bbd12017-03-06
0113-4368-79EA - Each0113-43684abd9a15-8206-4d60-bf29-504433dc3b2912023-03-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
NAPROXEN SODIUMACTIVE INGREDIENT9TN87S3A3C3
NAPROXENACTIVE MOIETY57Y76R9ATQ3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61U3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WO3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I303
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1A3
POVIDONESINACTIVE INGREDIENTFZ989GH94E3
TALCINACTIVE INGREDIENT7SEV7J4R1U3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JP3

Products#

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0113-43680113-4368-62, 0113-4368-71, 0113-4368-78, 0113-4368-76, 0113-4368-79, 0113-4368-75, 0113-4368-00, 0113-4368-82

Ingredients#

Complete SPL Sections#

Active ingredient (in each caplet)

OTC - ACTIVE INGREDIENT SECTION

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

Purposes

OTC - PURPOSE SECTION

Pain reliever/fever reducer

Uses

INDICATIONS & USAGE SECTION

• 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

Warnings

WARNINGS SECTION

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.

Directions

DOSAGE & ADMINISTRATION SECTION

• 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

Other information

STORAGE AND HANDLING SECTION

• each caplet contains: sodium 22 mg • store at 20-25°C (68-77°F). Avoid high humidity and excessive heat above 40°C (104°F).

Inactive ingredients

INACTIVE INGREDIENT SECTION

FD&C blue no. 2 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, talc, titanium dioxide

Questions or comments?

OTC - QUESTIONS SECTION

1-800-719-9260

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

GOODSENSE ® Strength To Last 12 Hours Naproxen Sodium Tablets, 220 mg Pain Reliever Fever Reducer (NSAID) Actual Size Compare to active ingredient of Aleve ® Caplets 50 Caplets** **Capsule-Shaped Tablets

Source Document#

Source XML