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...
(in each tablet)
Naproxen sodium 220 mg
(naproxen 200 mg) (NSAID)**
**nonsteroidal anti-inflammatory drug
(in each caplet)
Naproxen sodium 220 mg
(naproxen 200 mg) (NSAID)**
**nonsteroidal anti-inflammatory drug
Pain reliever/fever reducer
■ 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
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
NSAIDs, except aspirin, increase 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 you have ever had an allergic reaction to any other pain reliever/fever reducer
■ right before or after heart surgery
■ the 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, kidney disease, asthma, or had a stroke
■ you are taking a diuretic
■ you have problems or serious side effects from taking pain relievers or fever reducers
■ under a doctor’s care for any serious condition
■ taking any other drug
■ take with food or milk if stomach upset occurs
■ 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:
■ chest pain
■ trouble breathing
■ weakness in one part or side of body
■ slurred speech
■ leg swelling
■ 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 right away.
■ 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
■ 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 tablet contains: sodium 20 mg
■ store at 20 - 25°C (68 - 77°F). Avoid high humidity and excessive heat above 40°C (104°F)
■ 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)
FD&C blue #2 aluminum lake, hypromellose, maize starch, microcrystalline cellulose, polyethylene glycol, povidone, sodium starch glycolate, stearic acid, titanium dioxide.
1-877-770-3183 Mon - Fri 9:00 AM to 4:00 PM EST.
| 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 |
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 63940-761-05 | 2023-01-30 | C162847 | 48780-1 | f386c64a-11f7-0266-e053-dadaa90a7c1a | Naproxen Sodium Tablets, USP 220 mg (NSAID)** Pain reliever/fever reducer Strength to last 12 HOURS |
| 63940-763-05 | 2023-01-30 | C162847 | 48780-1 | f386c64a-11f7-0266-e053-dadaa90a7c1a | Naproxen Sodium Tablets, USP 220 mg (NSAID)** Pain reliever/fever reducer Strength to last 12 HOURS |
| 63940-763-10 | 2023-01-30 | C162847 | 48780-1 | f386c64a-11f7-0266-e053-dadaa90a7c1a | Naproxen Sodium Tablets, USP 220 mg (NSAID)** Pain reliever/fever reducer Strength to last 12 HOURS |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 63940-761-05 | Naproxen Sodium | 50 in 1 BOTTLE | TABLET | 50 | 2 | |
| 63940-763-05 | Naproxen Sodium | 50 in 1 BOTTLE | TABLET | 50 | 2 | |
| 63940-763-10 | Naproxen Sodium | 100 in 1 BOTTLE | TABLET | 100 | 2 |
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 63940-761 | NAPROXEN SODIUM TABLET [HARMON STORES INC.] | 2 | Legacy NDC, 1 package rows | 20191218_76a17f69-0071-e102-e053-2991aa0a3a66.zip |
| 63940-763 | NAPROXEN SODIUM TABLET [HARMON STORES INC.] | 2 | Legacy NDC, 2 package rows | 20191218_76a17f69-0071-e102-e053-2991aa0a3a66.zip |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 63940-761 | 63940-761-05 |
| 63940-763 | 63940-763-05, 63940-763-10 |
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 |
|---|---|---|---|---|---|---|---|
| A091353-001 | NAPROXEN SODIUM | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2011-09-20 |
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 | A091353-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2011-09-20 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A091353-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2011-09-20 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A091353-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2011-09-20 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091353-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2011-09-20 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A091353-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2011-09-20 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091353-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2011-09-20 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091353-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2011-09-20 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091353-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2011-09-20 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091353-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2011-09-20 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A091353-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2011-09-20 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A091353-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2011-09-20 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A091353-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2011-09-20 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A091353-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2011-09-20 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A091353-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2011-09-20 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A091353-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2011-09-20 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A091353-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2011-09-20 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A091353-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2011-09-20 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A091353-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2011-09-20 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A091353-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2011-09-20 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A091353-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2011-09-20 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A091353-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2011-09-20 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A091353-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2011-09-20 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A091353-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2011-09-20 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A091353-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2011-09-20 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A091353-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2011-09-20 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A091353-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2011-09-20 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A091353-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2011-09-20 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A091353-001 | NAPROXEN SODIUM | EQ 200MG BASE | TABLET / ORAL | 2011-09-20 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A091353-001 | NAPROXEN SODIUM | EQ 200MG BASE | TABLET / ORAL | 2011-09-20 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A091353-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2011-09-20 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A091353-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2011-09-20 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A091353-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2011-09-20 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A091353-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2011-09-20 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A091353-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2011-09-20 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A091353-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2011-09-20 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A091353-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2011-09-20 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A091353-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2011-09-20 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A091353-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2011-09-20 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A091353-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2011-09-20 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A091353-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2011-09-20 | 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 |
|---|---|---|---|---|---|---|
| 99eb0620-baf1-5fa1-e053-2a95a90a03d9 | 76a17f69-0071-e102-e053-2991aa0a3a66 | 2019-12-17 | Warnings | 99eb0620-baf1-5fa1-e053-2a95a90a03d9 76a17f69-0071-e102-e053-2991aa0a3a66 |
Adverse event summaries are temporarily unavailable. Other product information remains available.