Indications and uses
temporarily relieves minor aches and pain due to : backache headache menstrul cramps minor pain of arthritis muscular aches the common cold toothache temporarily reduces fever
temporarily relieves minor aches and pain due to : backache headache menstrul cramps minor pain of arthritis muscular aches the common cold toothache 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 one tablet every 8 to 12 hours while symptoms last for the first dose you may take within the first hour do not exceed 2 tablets in any 8 to 12 hours period do not exceed 3 tablets in 24 hour period Children under 12 years: Ask a doctor
each tablet contains : sodium 20 mg store between 20°-25°C(68-77°F). Avoid high humidity and excessive heat above 40°C(104°F)
Drug Facts
Naproxen sodium 220 mg
(naproxen 200 mg) (NSAID)**
**nonsteroidal anti-inflammatory drug
Pain reliever/
fever reducer
Warnings
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.
This product contains a non steroidal anti-inflammatory drug(NSAID), which may cause severe stomach bleeding. The chance is higher if you:
NSAID's 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.
If pregnant or breast feeding, ask a health profession 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 complication during the delivery.
Keep out of reach of children. In case of overdose, get medical help or contact a position control center right away (1-800-222-1222)
| |
| |
| |
Adults and Children 12 years and older: |
|
Children under 12 years: |
|
each tablet contains: sodium 20 mg
store between 20°-25°C(68-77°F). Avoid high humidity and excessive heat above 40°C(104°F)
colloidal silicon dioxide*,croscarmellose sodium*, FD&C Blue#2 lake,hypromellose, magnesium stearate*, maize starch*, microcrystalline cellulose, polyethylene glycol, povidone, sodium starch glycolate*,stearic acid*, titanium dioxide.
*contains one or more of these ingredients
Questions or comments?
1-888-333-9792
Compare to the active
ingredient in Aleve®†
ALL DAY
PAIN RELIEF
NAPROXEN SODIUM TABLETS, USP 220 mg
PAIN RELIEVER/FEVER REDUCER (NSAID)
| 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 |
| 594e2c86-3079-4e6e-96c9-48f7a8afc78d | Product name | 1 | 20230718 |
| 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 |
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 68210-4121-1 | 2023-01-30 | C162847 | 48780-1 | f386c649-9ded-0266-e053-dadaa90a7c1a | ValuMeds All Day Pain Relief (Naproxen Sodium 220mg) Tablets |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68210-4121-1 | Naproxen Sodium | 1 in 1 CARTON | TABLET, FILM COATED, EXTENDED RE | 1 | 1 | |
| 68210-4121-1 | Naproxen Sodium | 15 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 15 | 1 |
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 68210-4121 | NAPROXEN SODIUM TABLET, FILM COATED, EXTENDED RELEASE [SPIRIT PHARMACEUTICALS LLC] | 1 | Legacy NDC, 2 package rows | 20210108_02013f75-049e-48ac-b135-a8d8bd9a554d.zip |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 68210-4121 | 68210-4121-1 |
Every source-derived ingredient row is available through these pages.
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 |
|---|---|---|---|---|---|---|---|
| A207612-001 | NAPROXEN SODIUM | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2018-11-16 |
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 | A207612-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2018-11-16 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A207612-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2018-11-16 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A207612-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2018-11-16 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207612-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2018-11-16 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A207612-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2018-11-16 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A207612-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2018-11-16 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A207612-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2018-11-16 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A207612-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2018-11-16 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A207612-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2018-11-16 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A207612-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2018-11-16 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A207612-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2018-11-16 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A207612-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2018-11-16 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A207612-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2018-11-16 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A207612-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2018-11-16 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A207612-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2018-11-16 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A207612-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2018-11-16 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A207612-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2018-11-16 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A207612-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2018-11-16 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A207612-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2018-11-16 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A207612-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2018-11-16 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A207612-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2018-11-16 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A207612-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2018-11-16 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A207612-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2018-11-16 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A207612-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2018-11-16 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A207612-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2018-11-16 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A207612-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2018-11-16 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A207612-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2018-11-16 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A207612-001 | NAPROXEN SODIUM | EQ 200MG BASE | TABLET / ORAL | 2018-11-16 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A207612-001 | NAPROXEN SODIUM | EQ 200MG BASE | TABLET / ORAL | 2018-11-16 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A207612-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2018-11-16 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A207612-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2018-11-16 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A207612-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2018-11-16 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A207612-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2018-11-16 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A207612-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2018-11-16 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A207612-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2018-11-16 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A207612-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2018-11-16 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A207612-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2018-11-16 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A207612-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2018-11-16 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A207612-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2018-11-16 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A207612-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2018-11-16 | 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 |
|---|---|---|---|---|---|---|
| b8515846-3930-1493-e053-2a95a90a1f40 | 02013f75-049e-48ac-b135-a8d8bd9a554d | 2021-01-07 | Warnings | b8515846-3930-1493-e053-2a95a90a1f40 02013f75-049e-48ac-b135-a8d8bd9a554d |
Adverse event summaries are temporarily unavailable. Other product information remains available.