Flanax Menstrual Pain Reliever

Manufacturer: Belmora LLC
Effective date: 2026-01-27
Label type: HUMAN OTC DRUG LABEL
Version: 15
Source: full-release
Hydrated at: 2026-06-01 01:34:53

Label at a glance#

ProductFlanax Menstrual Pain Reliever

Active ingredientNAPROXEN SODIUM

Label structure9 sections

Indications and uses

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

Dosage and administration

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

each caplet 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

Contacts and useful links#

PhoneLabel contact1-888-779-2877

Websitewww.flanaxusa.com

www.flanaxusa.com

Websitewww.flanax.com

WWW.FLANAX.COM

Label contents#

Full prescribing information#

Active ingredient (in each caplet)

OTC - ACTIVE INGREDIENT SECTION

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

Purpose

OTC - PURPOSE SECTION

Pain reliever/fever reducer

Uses

INDICATIONS & USAGE SECTION

temporarily relieves minor aches and pains due to:
- menstrual cramps
- headache
- the common cold
- toothache
- muscular aches
- backache
- 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:

asthma (wheezing)
shock
facial swelling
rash
hives
skin reddening
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
take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]
take more or for a longer time than directed
have had stomach ulcers or bleeding problems
take a blood thinning (anticoagulant) or steroid drug
have 3 or more alcoholic drinks every day while using this product

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.

Do not use

OTC - DO NOT USE SECTION

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

OTC - ASK DOCTOR SECTION

you are taking a diuretic
the stomach bleeding warning applies to you
you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had a stroke
you have a history of stomach problems, such as heartburn
you have problems or serious side effects from taking pain relievers or fever reducers

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

taking aspirin for heart attack or stroke, because naproxen may decrease this benefit of aspirin
under a doctor’s care for any serious condition
taking any other drug

When using this product

OTC - WHEN USING SECTION

take with food or milk if stomach upset occurs

Stop use and ask a doctor if

OTC - STOP USE SECTION

you experience any of the following signs of stomach bleeding:
- have bloody or black stools
- have stomach pain that does not get better
- feel faint
- vomit blood
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
you have difficulty swallowing
fever gets worse or lasts more than 3 days
any new symptoms appear
it feels like the pill is stuck in your throat
redness or swelling is present in the painful area

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

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.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away.

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 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 ingredients

INACTIVE INGREDIENT SECTION

croscarmellose sodium, FD&C blue #2 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, talc, titanium dioxide

Questions or comments?

OTC - QUESTIONS SECTION

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

Principal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 27854-165-10

Belmora LLC

FLANAX^®

MENSTRUAL
PAIN RELIEVER

Naproxen Sodium Tablets,
220 mg (NSAID)

PAIN RELIEVER/
FEVER REDUCER

Actual Size

10 | CAPLETS

UP TO 12 HOURS
of menstrual pain relief

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

Distributed by: Belmora LLC
3101 Wilson Blvd. Suite 500
Arlington, VA 22201
www.flanaxusa.com

WWW.FLANAX.COM

REV1221C60403

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
849574	naproxen sodium 220 MG Oral Tablet	PSN	15
849574	naproxen sodium 220 MG Oral Tablet	SCD	15
849574	naproxen sodium 220 MG (as naproxen 200 MG) Oral Tablet	SY	15

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
NAPROXEN Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20191108

Product Linked Resources#

Resource, Code type, Value table
Resource	Code type	Value	Equivalent identifiers	Source image
Barcode	EAN-13	0853030002250	GTIN-13: 0853030002250 EAN-13: 0853030002250 GTIN-12: 853030002250 UPC-A: 853030002250 GTIN storage (14 digits): 00853030002250	flanax-44-604-1.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
fef6ad89-235f-4274-ba49-a8e53642473e	Product name	2	20250225
87fed3e6-8fba-48ef-96b0-3a7fb54b96ff	Product name	3	20230306
b5fdaaec-7251-4da6-9cb2-4e9e76939ec8	Product name	1	20200623
e76dbbc1-775d-722c-08ff-ed45e8a80def	Product name	3	20181002
6f4f4521-fd56-1ae6-888b-3b021bd75c7c	Product name	1	20140508
ce67e27d-1d21-5465-4409-b0662dd99d4d	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
27854-165-10	Flanax Menstrual Pain Reliever	1 in 1 CARTON	TABLET, FILM COATED	1		15
27854-165-10	Flanax Menstrual Pain Reliever	10 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	10		15

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

Flanax Menstrual Pain Reliever
Naproxen Sodium
NAPROXEN
CROSCARMELLOSE SODIUM
FD&C BLUE NO. 2 ALUMINUM LAKE
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
POLYETHYLENE GLYCOL, UNSPECIFIED
POLYVINYL ALCOHOL, UNSPECIFIED
POVIDONE, UNSPECIFIED
SILICON DIOXIDE
TALC
TITANIUM DIOXIDE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
27854-165	27854-165-10

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
NAPROXEN SODIUM	9TN87S3A3C	ACTIB
CROSCARMELLOSE SODIUM	M28OL1HH48	IACT
FD&C BLUE NO. 2 ALUMINUM LAKE	4AQJ3LG584	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
MICROCRYSTALLINE CELLULOSE	OP1R32D61U	IACT
POLYETHYLENE GLYCOL, UNSPECIFIED	3WJQ0SDW1A	IACT
POLYVINYL ALCOHOL, UNSPECIFIED	532B59J990	IACT
POVIDONE, UNSPECIFIED	FZ989GH94E	IACT
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
TALC	7SEV7J4R1U	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT

Source Document#

Source XML · Source PDF

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 44.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A204872-001	NAPROXEN SODIUM	NAPROXEN SODIUM	220MG	TABLET / ORAL			2017-01-23

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 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204872-001	NAPROXEN SODIUM	EQ 200MG BASE	TABLET / ORAL	2017-01-23	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A204872-001	NAPROXEN SODIUM	EQ 200MG BASE	TABLET / ORAL	2017-01-23	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`3a93d1ddd44b…`

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Flanax Menstrual Pain Reliever	NAPROXEN SODIUM	Belmora LLC	2b4135b3-389c-46e2-ae86-7674c2ab9a32	2026-01-27	Warnings	Exact identifier ndc (package): 27854-165-10 ndc (product): 27854-165 ndc11 (package): 27854016510 spl id: 6cbf25c7-2930-4fa4-84fa-01fe19cf6299 spl set id: 2b4135b3-389c-46e2-ae86-7674c2ab9a32

Reported adverse events (FAERS/openFDA)#

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