Indications and 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
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
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 to 12 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° to 25°C (68° to 77°F). Avoid high humidity and excessive heat above 40°C (104°F). read all warnings and directions before use
Naproxen sodium 220 mg
(naproxen 200 mg) (NSAID)*
*nonsteroidal anti-inflammatory drug
Pain reliever/fever reducer
Allergy alert: Naproxen sodium may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:
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:
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.
In case of overdose, get medical help or contact a Poison Control Center right away.
| Adults and children 12 years and older |
|
| Children under 12 years |
|
croscarmellose sodium, FD&C Blue #2, macrogol, magnesium stearate, polyvinyl alcohol, povidone, pregelatinized starch, talc and titanium dioxide
Call 1-877-753-3935 Monday-Friday 9AM-5PM EST
Compare to ALEVE® active ingredient
All Day Pain Relief
Naproxen Sodium Tablets, 220 mg
Pain Reliever/Fever Reducer (NSAID)
TABLETS
EASY OPEN CAP
NOT FOR HOUSEHOLDS WITH YOUNG CHILDREN
Do not use if inner seal under bottle cap imprinted with "Sealed for Your Protection" is broken or missing
†This product is not manufactured or distributed by Bayer Healthcare, LLC., owner of the registered trademark Aleve®.
DISTRIBUTED BY: CARDINAL HEALTH
DUBLIN, OH 43017
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| NAPROXEN SODIUM | ACTIVE INGREDIENT | 9TN87S3A3C | 1 | |
| NAPROXEN | ACTIVE MOIETY | 57Y76R9ATQ | 1 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | 1 | |
| FD&C BLUE NO. 2 | INACTIVE INGREDIENT | L06K8R7DQK | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | 1 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | 1 | |
| POLYVINYL ALCOHOL | INACTIVE INGREDIENT | 532B59J990 | 1 | |
| POVIDONES | INACTIVE INGREDIENT | FZ989GH94E | 1 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | 1 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 49781-046 | 49781-046-56 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| NAPROXEN SODIUM | 9TN87S3A3C | ACTIB |
| CROSCARMELLOSE SODIUM | M28OL1HH48 | IACT |
| FD&C BLUE NO. 2 | L06K8R7DQK | IACT |
| POLYETHYLENE GLYCOL, UNSPECIFIED | 3WJQ0SDW1A | IACT |
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| POLYVINYL ALCOHOL, UNSPECIFIED | 532B59J990 | IACT |
| POVIDONE | FZ989GH94E | IACT |
| STARCH, CORN | O8232NY3SJ | IACT |
| TALC | 7SEV7J4R1U | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, EXTENDED RELEASE / ORAL | 90 mg | ||
| FD&C BLUE NO. 2 | FD&C BLUE NO. 2 | L06K8R7DQK | SOAP / TOPICAL | NA | ||
| TALC | TALC | 7SEV7J4R1U | TABLET, FILM COATED / ORAL | 91 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | TABLET, FILM COATED / ORAL | 2000 mg | ||
| POVIDONES | POVIDONE | FZ989GH94E | DROPS / ORAL | NA | ||
| POVIDONES | POVIDONE | FZ989GH94E | SUSPENSION/ DROPS / OPHTHALMIC | 0.6 %w/v | ||
| POLYVINYL ALCOHOL | POLYVINYL ALCOHOL | 532B59J990 | SYSTEM / TOPICAL | 420 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | INSERT / VAGINAL | 147 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE, EXTENDED RELEASE / ORAL | 67 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | SUSPENSION / ORAL | 64 mg | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | CAPSULE, DELAYED RELEASE PELLETS / ORAL | 127 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | SUSPENSION, EXTENDED RELEASE / ORAL | 113 mg | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | TABLET / SUBLINGUAL | 10 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, FILM COATED / ORAL | 36 mg | ||
| POVIDONES | POVIDONE | FZ989GH94E | INJECTION / INTRAMUSCULAR | 0.2 %w/v | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | DROPS / ORAL | NA | ||
| POVIDONES | POVIDONE | FZ989GH94E | TROCHE / ORAL | 30 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | INSERT / VAGINAL | 69 mg | ||
| TALC | TALC | 7SEV7J4R1U | TABLET / ORAL | 1000 mg | ||
| TALC | TALC | 7SEV7J4R1U | CAPSULE, COATED PELLETS / ORAL | 14 mg | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | CAPSULE, EXTENDED RELEASE / ORAL | 53 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | SUPPOSITORY, EXTENDED RELEASE / INTRAUTERINE | 1 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | PASTE, DENTIFRICE / DENTAL | 0.4 %w/w | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, EXTENDED RELEASE / ORAL | 173 mg | ||
| TALC | TALC | 7SEV7J4R1U | TABLET / BUCCAL | 15 mg | ||
| TALC | TALC | 7SEV7J4R1U | GRANULE, DELAYED RELEASE / ORAL | 525 mg | ||
| FD&C BLUE NO. 2 | FD&C BLUE NO. 2 | L06K8R7DQK | TABLET, DELAYED RELEASE / ORAL | 0.2 mg | ||
| TALC | TALC | 7SEV7J4R1U | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | 357 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | POWDER / TOPICAL | 104 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | SUPPOSITORY / VAGINAL | NA | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | SOAP / TOPICAL | 1 %w/w | ||
| TALC | TALC | 7SEV7J4R1U | DROPS / ORAL | NA | ||
| TALC | TALC | 7SEV7J4R1U | TABLET, ORALLY DISINTEGRATING / ORAL | 80 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | TABLET, CHEWABLE / ORAL | 180 mg | ||
| POLYVINYL ALCOHOL | POLYVINYL ALCOHOL | 532B59J990 | SUSPENSION / AURICULAR (OTIC) | 0.05 %w/v | ||
| POLYVINYL ALCOHOL | POLYVINYL ALCOHOL | 532B59J990 | SUSPENSION / OPHTHALMIC | 1.4 %w/w | ||
| POVIDONES | POVIDONE | FZ989GH94E | CAPSULE, DELAYED RELEASE PELLETS / ORAL | 32 mg | ||
| FD&C BLUE NO. 2 | FD&C BLUE NO. 2 | L06K8R7DQK | TABLET, EXTENDED RELEASE / ORAL | 2.78 mg | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | CAPSULE, DELAYED RELEASE / ORAL | 72 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, SUGAR COATED / ORAL | NA | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE / RESPIRATORY (INHALATION) | NA | ||
| TALC | TALC | 7SEV7J4R1U | SUSPENSION / ORAL | 234 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | CAPSULE, EXTENDED RELEASE / ORAL | 194 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE / ORAL | 72 mg | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | POWDER, FOR SUSPENSION / ORAL | 11.25 mg | ||
| FD&C BLUE NO. 2 | FD&C BLUE NO. 2 | L06K8R7DQK | TABLET / BUCCAL | 0.01 mg | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | TABLET, ORALLY DISINTEGRATING / ORAL | 184 mg | ||
| TALC | TALC | 7SEV7J4R1U | GRANULE, FOR SUSPENSION / ORAL | 296 mg | ||
| POVIDONES | POVIDONE | FZ989GH94E | TABLET, FILM COATED / ORAL | 240 mg | ||
| POLYVINYL ALCOHOL | POLYVINYL ALCOHOL | 532B59J990 | SUSPENSION / ORAL | 5 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | INHALANT / ORAL | 0.08 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | INSERT, EXTENDED RELEASE / OPHTHALMIC | 0.4 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | SUSPENSION / ORAL | 113 mg | ||
| TALC | TALC | 7SEV7J4R1U | SUSPENSION, EXTENDED RELEASE / ORAL | 46 mg | ||
| TALC | TALC | 7SEV7J4R1U | CAPSULE, EXTENDED RELEASE / ORAL | 5119 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE, COATED / ORAL | 17 mg | ||
| POLYVINYL ALCOHOL | POLYVINYL ALCOHOL | 532B59J990 | SOLUTION / TOPICAL | 1.4 %w/v | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | CAPSULE / ORAL | 257 mg | ||
| TALC | TALC | 7SEV7J4R1U | TABLET, DELAYED RELEASE / ORAL | 349 mg | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | TABLET, DELAYED RELEASE PARTICLES / ORAL | 64 mg |
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 |
|---|---|---|---|---|---|---|---|
| A079096-001 | NAPROXEN SODIUM | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2008-12-16 |
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 | A079096-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2008-12-16 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A079096-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2008-12-16 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A079096-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2008-12-16 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A079096-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2008-12-16 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A079096-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2008-12-16 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A079096-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2008-12-16 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A079096-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2008-12-16 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A079096-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2008-12-16 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A079096-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2008-12-16 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A079096-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2008-12-16 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A079096-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2008-12-16 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A079096-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2008-12-16 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A079096-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2008-12-16 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A079096-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2008-12-16 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A079096-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2008-12-16 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A079096-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2008-12-16 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A079096-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2008-12-16 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A079096-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2008-12-16 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A079096-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2008-12-16 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A079096-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2008-12-16 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A079096-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2008-12-16 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A079096-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2008-12-16 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A079096-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2008-12-16 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A079096-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2008-12-16 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A079096-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2008-12-16 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A079096-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2008-12-16 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A079096-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2008-12-16 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A079096-001 | NAPROXEN SODIUM | EQ 200MG BASE | TABLET / ORAL | 2008-12-16 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A079096-001 | NAPROXEN SODIUM | EQ 200MG BASE | TABLET / ORAL | 2008-12-16 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A079096-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2008-12-16 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A079096-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2008-12-16 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A079096-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2008-12-16 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A079096-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2008-12-16 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A079096-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2008-12-16 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A079096-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2008-12-16 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A079096-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2008-12-16 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A079096-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2008-12-16 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A079096-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2008-12-16 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A079096-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2008-12-16 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A079096-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2008-12-16 | 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 |
|---|---|---|---|---|---|---|
| 421e35be-c7fd-4b75-b74d-7939ac024300 | 9e6b72ce-5b92-4200-a112-034c3bb9e0d2 | 2019-07-11 | Warnings | 421e35be-c7fd-4b75-b74d-7939ac024300 9e6b72ce-5b92-4200-a112-034c3bb9e0d2 |
Adverse event summaries are temporarily unavailable. Other product information remains available.