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
■ 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
Naproxen sodium 220 mg (naproxen 200 mg) (NSAID)*
*nonsteroidal anti-inflammatory drug
Pain reliever/ fever reducer
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
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.
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
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
■ 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 ingredients colloidal silicon dioxide, FD & C Blue#2 Aluminum Lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, titanium dioxide, talc
Call 1-888-779-2877 M-F 9AM-5PM EST
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
| Class | Version | Type | Effective |
|---|---|---|---|
| NAPROXEN Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20191108 |
| 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 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 27854-700-01 | Flanax Pain Reliever/Fever Reducer | 24 in 1 BOTTLE | TABLET, FILM COATED | 24 | 1 | |
| 27854-700-01 | Flanax Pain Reliever/Fever Reducer | 1 in 1 CARTON | TABLET, FILM COATED | 1 | 1 | |
| 27854-700-10 | Flanax Pain Reliever/Fever Reducer | 10 in 1 BOTTLE | TABLET, FILM COATED | 10 | 1 | |
| 27854-700-10 | Flanax Pain Reliever/Fever Reducer | 1 in 1 CARTON | TABLET, FILM COATED | 1 | 1 | |
| 27854-700-99 | Flanax Pain Reliever/Fever Reducer | 1 in 1 CARTON | TABLET, FILM COATED | 1 | 1 | |
| 27854-700-99 | Flanax Pain Reliever/Fever Reducer | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 27854-700 | 27854-700-01, 27854-700-10, 27854-700-99 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| NAPROXEN SODIUM | 9TN87S3A3C | ACTIM |
| SILICON DIOXIDE | ETJ7Z6XBU4 | IACT |
| FD&C BLUE NO. 2 | L06K8R7DQK | IACT |
| HYPROMELLOSE 2910 (5 MPA.S) | R75537T0T4 | IACT |
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| MICROCRYSTALLINE CELLULOSE | OP1R32D61U | IACT |
| POLYETHYLENE GLYCOL 8000 | Q662QK8M3B | IACT |
| POVIDONE K30 | U725QWY32X | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
| TALC | 7SEV7J4R1U | IACT |
All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A205497-001 | NAPROXEN SODIUM | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2016-03-18 |
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.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A205497-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2016-03-18 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A205497-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2016-03-18 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A205497-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2016-03-18 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A205497-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2016-03-18 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A205497-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2016-03-18 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A205497-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2016-03-18 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A205497-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2016-03-18 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A205497-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2016-03-18 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A205497-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2016-03-18 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A205497-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2016-03-18 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A205497-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2016-03-18 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A205497-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2016-03-18 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A205497-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2016-03-18 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A205497-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2016-03-18 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A205497-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2016-03-18 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A205497-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2016-03-18 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A205497-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2016-03-18 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A205497-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2016-03-18 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A205497-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2016-03-18 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A205497-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2016-03-18 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A205497-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2016-03-18 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A205497-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2016-03-18 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A205497-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2016-03-18 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A205497-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2016-03-18 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A205497-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2016-03-18 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A205497-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2016-03-18 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A205497-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2016-03-18 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A205497-001 | NAPROXEN SODIUM | EQ 200MG BASE | TABLET / ORAL | 2016-03-18 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A205497-001 | NAPROXEN SODIUM | EQ 200MG BASE | TABLET / ORAL | 2016-03-18 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A205497-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2016-03-18 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A205497-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2016-03-18 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A205497-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2016-03-18 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A205497-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2016-03-18 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A205497-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2016-03-18 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A205497-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2016-03-18 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A205497-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2016-03-18 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A205497-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2016-03-18 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A205497-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2016-03-18 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A205497-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2016-03-18 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A205497-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2016-03-18 | f41ea6bd6efb… |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Flanax Pain Reliever/Fever Reducer | NAPROXEN SODIUM | Belmora LLC | a93e4966-9dd3-40ba-b7d6-6ca8fef229c6 | 2020-05-15 | Warnings | 27854-700-10 27854-700-99 27854-700-01 27854-700 27854070010 27854070099 27854070001 4215c852-11ed-4b06-b132-3674265078e3 a93e4966-9dd3-40ba-b7d6-6ca8fef229c6 |
Adverse event summaries are temporarily unavailable. Other product information remains available.