Flanax Pain Reliever/Fever Reducer

Manufacturer
Belmora LLC
Effective date
2020-05-15
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:14:24

Label at a glance#

ProductFlanax Pain Reliever/Fever Reducer
Active ingredientNAPROXEN SODIUM
Label structure10 sections

Storage and handling

■ each tablet contains: sodium 20 mg ■ store at 20°-25°C (68°-77°F). Avoid high humidity and excessive heat above 40°C (104°F) ■ see end flap for expiration date and lot number

Label contents#

Full prescribing information#

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

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

*nonsteroidal anti-inflammatory drug

Purpose

OTC - PURPOSE SECTION

Pain reliever/ fever reducer

INDICATIONS & USAGE SECTION

Uses ■ temporarily relieves minor aches and pain due to: ■ headache ■ muscular aches ■ toothache ■ the common cold ■ backache ■ menstrual cramps ■ minor pain of arthritis

■ 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: ■ shock ■ facial swelling ■ asthma (wheezing) ■ hives ■ skin reddening ■ blisters ■ rash

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

■ have had stomach ulcers or bleeding problems

■ take blood thinning (anticoagulant) or steroid drug

■ are age 60 or older

■ take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]

■ take more or for a longer time than directed

■ have 3 or more alcoholic drinks every day while using this product.

Heart attack and stroke warning: NSAIDs, except aspirin, increases 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 are taking a diuretic

■ you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had a stroke

■ you have a 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 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: ■ leg swelling ■ chest pain ■ slurred speech ■ trouble breathing ■ weakness in one part or side of body

■ 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 during the last 3 months of 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 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 12 years and older

   ■ take 1 tablet every 8 to12 hours while symptoms last
   ■ for the first dose, you may take 2 tablets within the first hour
   ■ do not exceed 2 tablets in any 8-to 12-hour period
   ■ do not exceed 3 tablets in a 24-hour period

■ children under 12 years: ask a doctor

Other information

STORAGE AND HANDLING SECTION

■ each tablet contains: sodium 20 mg

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

■ see end flap for expiration date and lot number

INACTIVE INGREDIENT SECTION

Inactive ingredients colloidal silicon dioxide, FD & C Blue#2 Aluminum Lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, titanium dioxide, talc

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-888-779-2877 M-F 9AM-5PM EST

SPL UNCLASSIFIED SECTION

Longer Lasting Pain Relief

12 HOURS of pain relief

KEEP OUTER PACKAGE FOR COMPLETE PRODUCT INFORMATION

Distributed by Belmora LLC, 2011 Crystal Dr.#400 Arlington, VA 22202      
www.flanaxusa.com      

Made in India

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

FLX700FLX700

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
849574naproxen sodium 220 MG Oral TabletPSN1
849574naproxen sodium 220 MG Oral TabletSCD1
849574naproxen sodium 220 MG (as naproxen 200 MG) Oral TabletSY1

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
27854-700-01Flanax Pain Reliever/Fever Reducer24 in 1 BOTTLETABLET, FILM COATED241
27854-700-01Flanax Pain Reliever/Fever Reducer1 in 1 CARTONTABLET, FILM COATED11
27854-700-10Flanax Pain Reliever/Fever Reducer10 in 1 BOTTLETABLET, FILM COATED101
27854-700-10Flanax Pain Reliever/Fever Reducer1 in 1 CARTONTABLET, FILM COATED11
27854-700-99Flanax Pain Reliever/Fever Reducer1 in 1 CARTONTABLET, FILM COATED11
27854-700-99Flanax Pain Reliever/Fever Reducer100 in 1 BOTTLETABLET, FILM COATED1001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
27854-700FLANAX PAIN RELIEVER/FEVER REDUCER (NAPROXEN SODIUM) TABLET, FILM COATED [BELMORA LLC]1Current NDC, Legacy NDC, 6 package rows20200523_a93e4966-9dd3-40ba-b7d6-6ca8fef229c6.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
27854-70027854-700-01, 27854-700-10, 27854-700-99

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A205497-001NAPROXEN SODIUMNAPROXEN SODIUM220MGTABLET / ORAL2016-03-18

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A205497-001NAPROXEN SODIUM220MGTABLET / ORAL2016-03-1884e616aacf4f…
2026-08-18 06:07:402026-07A205497-001NAPROXEN SODIUM220MGTABLET / ORAL2016-03-18caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A205497-001NAPROXEN SODIUM220MGTABLET / ORAL2016-03-18011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205497-001NAPROXEN SODIUM220MGTABLET / ORAL2016-03-1831067a03dcf5…
2025-08-23 18:47 UTC2025-08A205497-001NAPROXEN SODIUM220MGTABLET / ORAL2016-03-186a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205497-001NAPROXEN SODIUM220MGTABLET / ORAL2016-03-18fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205497-001NAPROXEN SODIUM220MGTABLET / ORAL2016-03-18b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205497-001NAPROXEN SODIUM220MGTABLET / ORAL2016-03-1803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205497-001NAPROXEN SODIUM220MGTABLET / ORAL2016-03-182680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205497-001NAPROXEN SODIUM220MGTABLET / ORAL2016-03-185bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205497-001NAPROXEN SODIUM220MGTABLET / ORAL2016-03-18d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A205497-001NAPROXEN SODIUM220MGTABLET / ORAL2016-03-18d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205497-001NAPROXEN SODIUM220MGTABLET / ORAL2016-03-1879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205497-001NAPROXEN SODIUM220MGTABLET / ORAL2016-03-18301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A205497-001NAPROXEN SODIUM220MGTABLET / ORAL2016-03-181e350fbaab3a…
2024-05-31 18:47 UTC2024-05A205497-001NAPROXEN SODIUM220MGTABLET / ORAL2016-03-188072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A205497-001NAPROXEN SODIUM220MGTABLET / ORAL2016-03-185c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A205497-001NAPROXEN SODIUM220MGTABLET / ORAL2016-03-185d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A205497-001NAPROXEN SODIUM220MGTABLET / ORAL2016-03-184b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A205497-001NAPROXEN SODIUM220MGTABLET / ORAL2016-03-1874a2ff9319b5…
2022-03-09 01:35 UTC2022-03A205497-001NAPROXEN SODIUM220MGTABLET / ORAL2016-03-18bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A205497-001NAPROXEN SODIUM220MGTABLET / ORAL2016-03-18782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A205497-001NAPROXEN SODIUM220MGTABLET / ORAL2016-03-1887673890dc5c…
2021-03-12 10:30 UTC2021-03A205497-001NAPROXEN SODIUM220MGTABLET / ORAL2016-03-185aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A205497-001NAPROXEN SODIUM220MGTABLET / ORAL2016-03-188869cabd3fbd…
2020-11-12 02:37 UTC2020-11A205497-001NAPROXEN SODIUM220MGTABLET / ORAL2016-03-18c0c555d07b60…
2019-12-14 00:12 UTC2019-12A205497-001NAPROXEN SODIUM220MGTABLET / ORAL2016-03-183f01610625f2…
2019-09-15 20:21 UTC2019-09A205497-001NAPROXEN SODIUMEQ 200MG BASETABLET / ORAL2016-03-18b00525d2431f…
2019-07-19 19:46 UTC2019-07A205497-001NAPROXEN SODIUMEQ 200MG BASETABLET / ORAL2016-03-18ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A205497-001NAPROXEN SODIUM220MGTABLET / ORAL2016-03-186a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A205497-001NAPROXEN SODIUM220MGTABLET / ORAL2016-03-181c564ffb4f44…
2023-12-20 04:57 UTC2023-12A205497-001NAPROXEN SODIUM220MGTABLET / ORAL2016-03-18ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A205497-001NAPROXEN SODIUM220MGTABLET / ORAL2016-03-18a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A205497-001NAPROXEN SODIUM220MGTABLET / ORAL2016-03-189b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A205497-001NAPROXEN SODIUM220MGTABLET / ORAL2016-03-18a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A205497-001NAPROXEN SODIUM220MGTABLET / ORAL2016-03-183f0d92c62455…
2023-05-13 08:27 UTC2023-05A205497-001NAPROXEN SODIUM220MGTABLET / ORAL2016-03-18053a50430f4f…
2023-01-26 05:58 UTC2023-01A205497-001NAPROXEN SODIUM220MGTABLET / ORAL2016-03-183bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A205497-001NAPROXEN SODIUM220MGTABLET / ORAL2016-03-183a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A205497-001NAPROXEN SODIUM220MGTABLET / ORAL2016-03-18f41ea6bd6efb…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Flanax Pain Reliever/Fever ReducerNAPROXEN SODIUMBelmora LLCa93e4966-9dd3-40ba-b7d6-6ca8fef229c62020-05-15WarningsExact identifier
ndc (package): 27854-700-10
ndc (package): 27854-700-99
ndc (package): 27854-700-01
ndc (product): 27854-700
ndc11 (package): 27854070010
ndc11 (package): 27854070099
ndc11 (package): 27854070001
spl id: 4215c852-11ed-4b06-b132-3674265078e3
spl set id: a93e4966-9dd3-40ba-b7d6-6ca8fef229c6

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.