Indications and uses
temporarily relieves minor aches and pains due to: ■ minor pain of arthritis ■ backache ■ headache ■ muscular aches ■ menstrual cramps ■ toothache ■ common cold ■ temporarily reduces fever
temporarily relieves minor aches and pains due to: ■ minor pain of arthritis ■ backache ■ headache ■ muscular aches ■ menstrual cramps ■ toothache ■ 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 8-12 hour period do not exceed 3 caplets in a 24-hour period Children under 12 years : ask a doctor
Naproxen sodium 220mg
(naproxen 200mg) (NSAID)*
*nonsteroidal anti-inflammatory drug
Pain reliever/fever reducer
temporarily relieves minor aches and pains due to: ■ minor pain of arthritis ■ backache ■ headache
■ muscular aches ■ menstrual cramps ■ toothache ■ common cold ■ temporarily reduces fever
Naproxen sodium may cause a severe allergic reaction, especially in people allergic to aspirin.
Symptoms may include ■ hives ■ facial swelling ■ asthma(wheezing) ■ shock■ skin reddening
■ rash ■ blisters
If an allergic reaction occurs, stop use and seek medical help right away
This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if
you ■ are age 60 or older ■ have had stomach ulcers or bleeding problems ■ take a blood thinning (anticoagulant) or steroid drug ■ take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others) ■ have 3 or more alcoholic drinks every day while using this product ■ take more or for a longer time than directed
if you have ever had an allergic reaction to any other pain reliever/fever reducer ■ right before or
after heart surgery
■ stomach bleeding warning applies to you you have a history of stomach problems, such as heartburn you have high blood pressure, heart disease, liver cirrhosis, or kidney disease ■ you are taking a diuretic ■ you have problems or serious side effects from taking pain relievers or fever reducers ■ you have asthma
under a doctor’s care for any serious condition
take with food or milk if stomach upset occursthe risk of heart attack or stroke may increase if you use more than directed or for longer than directed
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 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
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 immediately
■ 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 8-12 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 20-25° C (68-77° F). ■ avoid high humidity and excessive heat above 40° C (104° F). Do not use if tamper evident seal under bottle cap is broken or missing.
croscarmellose sodium, FD&C blue #2 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol,
povidone, silicon dioxide, titanium dioxide
| 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 |
|---|---|---|---|---|---|---|
| 69168-362-07 | Naproxen CapletsAll day relief for pain | 1 in 1 CARTON | TABLET | 1 | 6 | |
| 69168-362-07 | Naproxen CapletsAll day relief for pain | 10 in 1 BOTTLE | TABLET | 10 | 6 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 69168-362 | 69168-362-07 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| NAPROXEN SODIUM | 9TN87S3A3C | ACTIB |
| SILICON DIOXIDE | ETJ7Z6XBU4 | IACT |
| CROSCARMELLOSE SODIUM | M28OL1HH48 | IACT |
| FD&C BLUE NO. 2 | L06K8R7DQK | IACT |
| HYPROMELLOSES | 3NXW29V3WO | IACT |
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| CELLULOSE, MICROCRYSTALLINE | OP1R32D61U | IACT |
| POLYETHYLENE GLYCOL, UNSPECIFIED | 3WJQ0SDW1A | IACT |
| POVIDONE | FZ989GH94E | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | 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 |
|---|---|---|---|---|---|---|---|
| A090545-001 | NAPROXEN SODIUM | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2011-03-16 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | A090545-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2011-03-16 | c2088c7a36db… | ||
| 2026-09-14 22:38:34 | 2026-08 | A090545-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2011-03-16 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A090545-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2011-03-16 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A090545-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2011-03-16 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090545-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2011-03-16 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A090545-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2011-03-16 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090545-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2011-03-16 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090545-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2011-03-16 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090545-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2011-03-16 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090545-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2011-03-16 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090545-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2011-03-16 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090545-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2011-03-16 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A090545-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2011-03-16 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090545-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2011-03-16 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A090545-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2011-03-16 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A090545-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2011-03-16 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A090545-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2011-03-16 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A090545-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2011-03-16 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A090545-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2011-03-16 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A090545-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2011-03-16 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A090545-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2011-03-16 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A090545-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2011-03-16 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A090545-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2011-03-16 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A090545-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2011-03-16 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A090545-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2011-03-16 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A090545-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2011-03-16 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A090545-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2011-03-16 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A090545-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2011-03-16 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A090545-001 | NAPROXEN SODIUM | EQ 200MG BASE | TABLET / ORAL | 2011-03-16 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A090545-001 | NAPROXEN SODIUM | EQ 200MG BASE | TABLET / ORAL | 2011-03-16 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A090545-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2011-03-16 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A090545-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2011-03-16 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A090545-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2011-03-16 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A090545-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2011-03-16 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A090545-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2011-03-16 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A090545-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2011-03-16 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A090545-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2011-03-16 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A090545-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2011-03-16 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A090545-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2011-03-16 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A090545-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2011-03-16 | 3a93d1ddd44b… |
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 |
|---|---|---|---|---|---|---|
| Naproxen Caplets All day relief for pain | NAPROXEN SODIUM 220 MG | Allegiant Health | 81ab5ec4-23c5-44da-b6c8-62f3d3077d48 | 2018-11-07 | Warnings | 69168-362-07 69168-362 69168036207 18185cb8-53e0-4d19-ba7f-46d57e6f911a 81ab5ec4-23c5-44da-b6c8-62f3d3077d48 |
Adverse event summaries are temporarily unavailable. Other product information remains available.