Indications and uses
■ temporarily relieves minor aches and pains due to: ■ minor pain of arthritis ■ muscular aches ■ backache ■ headache ■ menstrual cramps ■ toothache ■ the common cold ■ temporarily reduces fever
■ temporarily relieves minor aches and pains due to: ■ minor pain of arthritis ■ muscular aches ■ backache ■ headache ■ menstrual cramps ■ 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 ...
■ 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) ■ read all product information before using ■ TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
Drug Facts
Active ingredient (in each caplet) Purpose
Naproxen Sodium 220 mg
(naproxen 200mg) (NSAID)* ....................Pain reliever / Fever reducer
*nonsteroidal anti-inflammatory drug
■ temporarily relieves minor aches and pains due to:
■ minor pain of arthritis ■ muscular aches ■ backache ■ headache
■ menstrual cramps ■ 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
■ 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, 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
■ taking any other drug
■ take with food or milk if stomach upset occurs
■ the 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
If pregnant or breast-feeding, 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.
Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
■ 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 20-25° C (68-77° F).
■ avoid high humidity and excessive heat above 40° C (104° F)
■ read all product information before using
■ TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
colloidal silicon dioxide, croscarmellose sodium, FD&C Blue #2 lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, titanium dioxide
Call toll free 1-844-832-1138 Monday through Friday 9AM – 5PM EST or
www.healthlifeofusa.com
See New Warnings Information & Directions
Compare to the Active Ingredients in Aleve®.
ALL DAY PAIN RELIEF
Naproxen Sodium Tablets, 220 mg
| Class | Version | Type | Effective |
|---|---|---|---|
| NAPROXEN Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20191108 |
| Resource | Code type | Value | Equivalent identifiers | Source image |
|---|---|---|---|---|
| Barcode | EAN-13 | 0069517109248 | GTIN-13: 0069517109248 EAN-13: 0069517109248 GTIN-12: 069517109248 UPC-A: 069517109248 GTIN storage (14 digits): 00069517109248 | Naproxen.jpg |
| Data code | ITF | 963667 | Naproxen.jpg |
| 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 |
|---|---|---|---|---|---|---|
| 69517-109-01 | All Day Pain Relief | 100 in 1 BOTTLE | TABLET | 100 | 4 | |
| 69517-109-02 | All Day Pain Relief | 2 in 1 POUCH | TABLET | 2 | 4 | |
| 69517-109-04 | All Day Pain Relief | 400 in 1 BOTTLE | TABLET | 400 | 4 | |
| 69517-109-24 | All Day Pain Relief | 24 in 1 BOTTLE | TABLET | 24 | 4 | |
| 69517-109-24 | All Day Pain Relief | 1 in 1 CARTON | TABLET | 1 | 4 | |
| 69517-109-25 | All Day Pain Relief | 25 in 1 BOX | TABLET | 25 | 4 | |
| 69517-109-25 | All Day Pain Relief | 2 in 1 POUCH | TABLET | 2 | 4 | |
| 69517-109-50 | All Day Pain Relief | 2 in 1 POUCH | TABLET | 2 | 4 | |
| 69517-109-50 | All Day Pain Relief | 50 in 1 BOX | TABLET | 50 | 4 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 69517-109 | 69517-109-25, 69517-109-50, 69517-109-02, 69517-109-24, 69517-109-01, 69517-109-04 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| NAPROXEN SODIUM | 9TN87S3A3C | ACTIM |
| HYPROMELLOSES | 3NXW29V3WO | IACT |
| FD&C BLUE NO. 2 | L06K8R7DQK | IACT |
| POVIDONE K30 | U725QWY32X | IACT |
| STARCH, CORN | O8232NY3SJ | IACT |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | 5856J3G2A2 | IACT |
| CELLULOSE, MICROCRYSTALLINE | OP1R32D61U | IACT |
| POLYETHYLENE GLYCOL 400 | B697894SGQ | IACT |
| STEARIC ACID | 4ELV7Z65AP | 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 |
|---|---|---|---|---|---|---|---|
| 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | A091353-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2011-09-20 | c2088c7a36db… | ||
| 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… |
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 |
|---|---|---|---|---|---|---|
| All Day Pain Relief | NAPROXEN SODIUM TABLETS, 220 MG | HealthLife of USA LLC | 7b0cb91e-5465-40ef-9f82-919f7d984f17 | 2017-06-01 | Warnings | 69517-109-04 69517-109-25 69517-109-02 69517-109-01 69517-109-50 69517-109-24 69517-109 69517010950 69517010901 69517010904 69517010925 69517010902 69517010924 046b91ed-d78b-42c0-b822-77fcbdeff84b 7b0cb91e-5465-40ef-9f82-919f7d984f17 |
Adverse event summaries are temporarily unavailable. Other product information remains available.