Naproxen Sodium Capsule, 220mg

Manufacturer
VALU MERCHANDISERS COMPANY | Bionpharma Inc. | Patheon Softgels Inc.
Effective date
2023-10-03
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:56:25

Key Label Information#

Active Ingredients And Purpose

Active ingredient (in each capsule)

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

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 if taken with food, this product may take longer to work adults and children 12 years and older: take 1 capsule every 8 to 12 hours while symptoms last for the first dose you may take 2 capsules within the first hour do not exceed 2 capsules in any 8- to 12-hour period do not exceed 3 capsules in a 24-hour period children under 12 years: ask a doctor

Other Label Information

Other information

each capsule contains: sodium 20 mg store at 20-25°C (68-77°F). Avoid high humidity and excessive heat above 40°C (104°F). Protect from light. read all directions and warnings before use. Keep carton.

Inactive ingredients

FD&C blue #1, gelatin, glycerin, lactic acid, mannitol, pharmaceutical ink, polyethylene glycol, povidone, propylene glycol, purified water, sorbitan, sorbitol

Questions or comments?

1-888-235-2466 (Mon – Fri 9AM – 5PM EST)

PRINCIPAL DISPLAY PANEL - 220 mg Capsule Bottle Carton

*Compare to the active ingredient of ALEVE ® Liquid Gels Naproxen Sodium CAPSULES 220 mg (NSAID) PAIN RELIEVER FEVER REDUCER Strength to last 12 hours 50 CAPSULES

Label Images#

image001
image001

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1112231naproxen sodium 220 MG Oral CapsulePSN2
1112231naproxen sodium 220 MG Oral CapsuleSCD2
1112231naproxen sodium 220 MG (as naproxen 200 MG) Oral CapsuleSY2

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
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
b5fdaaec-7251-4da6-9cb2-4e9e76939ec8Product name120200623
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
e76dbbc1-775d-722c-08ff-ed45e8a80defProduct name320181002
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
6f4f4521-fd56-1ae6-888b-3b021bd75c7cProduct name120140508
ce67e27d-1d21-5465-4409-b0662dd99d4dProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63941-681-16Naproxen Sodium50 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED502
63941-681-16Naproxen Sodium1 in 1 CARTONCAPSULE, LIQUID FILLED12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63941-681NAPROXEN SODIUM CAPSULE, LIQUID FILLED [VALU MERCHANDISERS COMPANY]2Current NDC, 2 package rows20231004_fed305f1-e32d-e1ff-e053-6294a90a273d.zip

Products#

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63941-68163941-681-16

Ingredients#

Complete SPL Sections#

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each capsule)

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

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 if taken with food, this product may take longer to work adults and children 12 years and older: take 1 capsule every 8 to 12 hours while symptoms last for the first dose you may take 2 capsules within the first hour do not exceed 2 capsules in any 8- to 12-hour period do not exceed 3 capsules in a 24-hour period children under 12 years: ask a doctor

Other information

STORAGE AND HANDLING SECTION

each capsule contains: sodium 20 mg store at 20-25°C (68-77°F). Avoid high humidity and excessive heat above 40°C (104°F). Protect from light. read all directions and warnings before use. Keep carton.

Inactive ingredients

INACTIVE INGREDIENT SECTION

FD&C blue #1, gelatin, glycerin, lactic acid, mannitol, pharmaceutical ink, polyethylene glycol, povidone, propylene glycol, purified water, sorbitan, sorbitol

Questions or comments?

OTC - QUESTIONS SECTION

1-888-235-2466 (Mon – Fri 9AM – 5PM EST)

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

Do not use if printed safety seal under cap is torn or missing. ***This product is not manufactured or distributed by the owners of ALEVE ® Liquid Gels. PROUDLY DISTRIBUTED BY: ASSOCIATED WHOLESALE GROCERS, INC., KANSAS CITY, KANSAS 66106 For product information please visit: bestchoicebrand.com/66726 BEST CHOICE 66726 0923 BP L0000716 R0523

PRINCIPAL DISPLAY PANEL - 220 mg Capsule Bottle Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

*Compare to the active ingredient of ALEVE ® Liquid Gels Naproxen Sodium CAPSULES 220 mg (NSAID) PAIN RELIEVER FEVER REDUCER Strength to last 12 hours 50 CAPSULES

Source Document#

Source XML