Indications and uses
temporarily relieves minor aches and pain due to: minor pain of arthritis muscular aches backache menstrual cramps headache toothache the common cold temporarily reduces fever
temporarily relieves minor aches and pain 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 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
each caplet contains: sodium 20 mg store at 20 o - 25 o C (68 o - 77 o F). Avoid high humidity and excessive heat above 40°C (104°F)
Naproxen sodium, USP 220 mg (naproxen 200 mg) (NSAID)**
**nonsteroidal anti-inflammatory drug
Pain reliever/ fever reducer
backache
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:
you are taking a diuretic
you experience any of the following signs of stomach bleeding:
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. (1-800-222-1222)
| 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
Preferred Plus Pharmacy
NDC 61715-060-50
SEE NEW WARNINGS INFORMATION
*Compare to the Active Ingredient in Aleve®
Naproxen Sodium Tablets, USP 220 mg
Pain Reliever/Fever Reducer (NSAID)
50 COATED CAPLETS†
†CAPSULE-SHAPED TABLETS
Distributed By:
Kinray, Inc., Whitestone, NY 11357
(c) 2013 Kinray Inc., All Rights Reserved, PREFERRED PLUS, PREFERRED PLUS ++++ and the PREFERRED PLUS logo are trademarks and/or registered trademarks of Kinray Inc. All other marks are property of their respective owners.
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 61715-060-50 | 2025-05-22 | C162847 | 48780-1 | 9d75b9d1-0c06-f424-e053-dadaa90a57ce | Drug Facts |
| 61715-060-51 | 2025-05-22 | C162847 | 48780-1 | 9d75b9d1-0c06-f424-e053-dadaa90a57ce | Drug Facts |
| 61715-060-50 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d1-0c06-f424-e053-dadaa90a57ce | Drug Facts |
| 61715-060-51 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d1-0c06-f424-e053-dadaa90a57ce | Drug Facts |
| 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 | |
| POVIDONE | INACTIVE INGREDIENT | FZ989GH94E | 1 | |
| STARCH, PREGELATINIZED 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 |
|---|---|
| 61715-060 | 61715-060-50, 61715-060-51 |
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 GLYCOLS | 3WJQ0SDW1A | IACT |
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| POLYVINYL ALCOHOL | 532B59J990 | IACT |
| POVIDONE | FZ989GH94E | IACT |
| STARCH, PREGELATINIZED 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 |
|---|---|---|---|---|---|---|
| POLYVINYL ALCOHOL | POLYVINYL ALCOHOL | 532B59J990 | SUSPENSION / OPHTHALMIC | 1.4 %w/w | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | GEL / TOPICAL | 0.06 %w/w | ||
| POLYVINYL ALCOHOL | POLYVINYL ALCOHOL | 532B59J990 | CAPSULE / ORAL | 1.67 mg | ||
| POVIDONE | POVIDONE | FZ989GH94E | FILM, EXTENDED RELEASE / TRANSDERMAL | NA | ||
| POVIDONE | POVIDONE | FZ989GH94E | SUSPENSION / ORAL | 20 mg/5ml | ||
| POLYVINYL ALCOHOL | POLYVINYL ALCOHOL | 532B59J990 | TABLET, COATED / ORAL | 0.7 mg | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | CAPSULE, DELAYED RELEASE / ORAL | 72 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | SYSTEM / TOPICAL | 420 mg | ||
| FD&C BLUE NO. 2 | FD&C BLUE NO. 2 | L06K8R7DQK | TABLET, DELAYED RELEASE / ORAL | 0.2 mg | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | TABLET, FOR SUSPENSION / ORAL | 1875 mg | ||
| POLYVINYL ALCOHOL | POLYVINYL ALCOHOL | 532B59J990 | TABLET / ORAL | 165 mg | ||
| TALC | TALC | 7SEV7J4R1U | GRANULE, FOR SUSPENSION / ORAL | 296 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | SYSTEM / INTRAVITREAL | 0.02 mg | ||
| FD&C BLUE NO. 2 | FD&C BLUE NO. 2 | L06K8R7DQK | TABLET, EXTENDED RELEASE / ORAL | 2.78 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | CAPSULE / ORAL | 256.4 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | SUPPOSITORY, EXTENDED RELEASE / INTRAUTERINE | 1 mg | ||
| POLYVINYL ALCOHOL | POLYVINYL ALCOHOL | 532B59J990 | SOLUTION/ DROPS / OPHTHALMIC | 1.4 %w/v | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | FILM, EXTENDED RELEASE / TRANSDERMAL | NA | ||
| TALC | TALC | 7SEV7J4R1U | TABLET, SUGAR COATED / ORAL | NA | ||
| POVIDONE | POVIDONE | FZ989GH94E | TABLET, EXTENDED RELEASE / ORAL | 101 mg | ||
| TALC | TALC | 7SEV7J4R1U | POWDER / TOPICAL | 9235 mg | ||
| STARCH, PREGELATINIZED CORN | STARCH, CORN | O8232NY3SJ | SUSPENSION / ORAL | 900 mg | ||
| STARCH, PREGELATINIZED CORN | STARCH, CORN | O8232NY3SJ | POWDER, FOR SUSPENSION / ORAL | 34 mg | ||
| POVIDONE | POVIDONE | FZ989GH94E | TABLET, CHEWABLE / ORAL | 48 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, CHEWABLE, EXTENDED RELEASE / ORAL | 9 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | FILM, SOLUBLE / ORAL | 2 mg | ||
| POVIDONE | POVIDONE | FZ989GH94E | CAPSULE, COATED PELLETS / ORAL | 10.03 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, COATED / ORAL | 184 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | POWDER, FOR SUSPENSION / ORAL | 297 mg | ||
| POVIDONE | POVIDONE | FZ989GH94E | SOLUTION / ORAL | 3000 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE, EXTENDED RELEASE / ORAL | 67 mg | ||
| POVIDONE | POVIDONE | FZ989GH94E | CAPSULE, DELAYED RELEASE PELLETS / ORAL | 32 mg | ||
| STARCH, PREGELATINIZED CORN | STARCH, CORN | O8232NY3SJ | TABLET, ORALLY DISINTEGRATING / ORAL | 100 mg | ||
| POVIDONE | POVIDONE | FZ989GH94E | INJECTION / INTRAMUSCULAR | 0.2 %w/v | ||
| POLYVINYL ALCOHOL | POLYVINYL ALCOHOL | 532B59J990 | SOLUTION / OPHTHALMIC | 6 mg | ||
| TALC | TALC | 7SEV7J4R1U | CAPSULE, COATED / ORAL | 87 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | CAPSULE, DELAYED RELEASE / ORAL | 1060 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE, DELAYED RELEASE / ORAL | 55 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | PASTE / DENTAL | 0.5 %w/w | ||
| TALC | TALC | 7SEV7J4R1U | TABLET, EXTENDED RELEASE / ORAL | 300 mg | ||
| TALC | TALC | 7SEV7J4R1U | TABLET, CHEWABLE, EXTENDED RELEASE / ORAL | 18 mg | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | TABLET, DELAYED RELEASE / ORAL | 280 mg | ||
| TALC | TALC | 7SEV7J4R1U | GRANULE / ORAL | 322 mg | ||
| STARCH, PREGELATINIZED CORN | STARCH, CORN | O8232NY3SJ | SUSPENSION, EXTENDED RELEASE / ORAL | 113 mg | ||
| POVIDONE | POVIDONE | FZ989GH94E | TABLET, FOR SUSPENSION / ORAL | 2 mg | ||
| POVIDONE | POVIDONE | FZ989GH94E | TABLET, DELAYED RELEASE / ORAL | 53 mg | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | TABLET / ORAL | 736 mg | ||
| STARCH, PREGELATINIZED CORN | STARCH, CORN | O8232NY3SJ | TABLET / ORAL | 1116 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | POWDER, FOR SUSPENSION / ORAL | 120 mg | ||
| TALC | TALC | 7SEV7J4R1U | TABLET / BUCCAL | 15 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | LOZENGE / ORAL | 420 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | SUSPENSION / ORAL | 113 mg | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | GRANULE, FOR SUSPENSION / ORAL | 282 mg | ||
| TALC | TALC | 7SEV7J4R1U | TABLET / ORAL | 1000 mg | ||
| POVIDONE | POVIDONE | FZ989GH94E | SYSTEM / TOPICAL | 41 mg | ||
| TALC | TALC | 7SEV7J4R1U | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 60 mg | ||
| FD&C BLUE NO. 2 | FD&C BLUE NO. 2 | L06K8R7DQK | TABLET, FILM COATED / ORAL | 2 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | POWDER / ORAL | 25 mg | ||
| POVIDONE | POVIDONE | FZ989GH94E | TABLET, ORALLY DISINTEGRATING / ORAL | 15.03 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, CHEWABLE / ORAL | 127 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 |
|---|---|---|---|---|---|---|
| a0709430-13fe-447a-b792-b03c184956ac | e1ea637b-9586-40ba-8729-a1d22690a627 | 2025-05-16 | Warnings | e1ea637b-9586-40ba-8729-a1d22690a627 |
Adverse event summaries are temporarily unavailable. Other product information remains available.