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
Naproxen
- Manufacturer
- Safetec of America, Inc.
- Effective date
- 2020-01-20
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- full-release
- Hydrated at
- 2026-05-31 23:03:27
Label at a glance#
ProductNaproxen
Active ingredientNaproxen Sodium
Label structure12 sections
Dosage and administration
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 under12 years ask a doctor
Contacts and useful links#
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Drug Facts
Active ingredient (in each tablet)
Naproxen sodium 220 mg (NSAID)**
Purposes
Pain reliever/fever reducer (naproxen 200 mg) ** nonsteroidal anti-inflammatory drug
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
Warnings
SPL UNCLASSIFIED SECTION
Allergy alert: 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.
SPL UNCLASSIFIED SECTION
Stomach bleeding warning: 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
SPL UNCLASSIFIED SECTION
Heart attack and stroke warning: 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.
Do not use
- if you have ever had an allergic reaction to any other pain reliever/fever reducer
- right before or after heart surgery
Ask a doctor before use if
- the stomach bleeding warning applies to you
- you have a history of stomach problems, such as heartburn
- you have had 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
Ask a doctor or pharmacist before use if you are
- under a doctor's care for any serious condition
- taking any other drug
When using this product
- take with food or milk if stomach upset occurs
Stop use and ask a doctor if
- 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
OTC - PREGNANCY OR BREAST FEEDING SECTION
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.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
- 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 |
|
| Children under12 years |
|
Other information
- 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).
Inactive ingredients
FD&C blue#2 aluminum lake, hypromellose, maize starch, microcrystalline cellulose, polyethylene glycol, povidone k-30, sodium starch glycolate, stearic acid, titanium dioxide
Questions or comments?
Call toll free: 1-800-456-7077
Principal Display Panel – Pouch Label
Safetec
of America, Inc.
DO NOT USE IF POUCH IS TORN OR DAMAGED
Manufactured for Safetec of America, Inc.
Buffalo NY 14215
Naproxen Sodium Tablets USP, 220 mg (NSAID)**
Pain reliever/fever reducer
STRENGTH TO LAST 12 HOURS
Contains no Ingredient made from a
gluten-containing grain (wheat, barley, or rye)
1 Tablet
Principal Display Panel – 50-Pouch Carton Label
Safetec®
of America, Inc.
Compare to the active ingredient
in Aleve®
Tablets*
NDC 61010-4410-1
STRENGTH TO LAST 12 HOURS
Naproxen Sodium
Tablets USP, 220 mg (NSAID)**
Pain Reliever/Fever Reducer
PUSH TO OPEN
Dispense through
opening
Contains no ingredient made from a gluten-containing
grain (wheat, barley, or rye)
- Relieves minor aches and pains
- Fever reducer
- Lasts up to 12 hours
TAMPER EVIDENT UNIT DOSE POUCHES
DO NOT USE IF POUCH IS TORN OR DAMAGED
50 Pouches
1 Tablet per Pouch
Principal Display Panel – 100-Pouch Carton Label
Safetec®
of America, Inc.
Compare to the active ingredient
in Aleve®
Tablets*
NDC 61010-4410-2
STRENGTH TO LAST 12 HOURS
Naproxen Sodium
Tablets USP, 220 mg (NSAID)**
Pain Reliever/Fever Reducer
Contains no ingredient made from a gluten-containing
grain (wheat, barley, or rye)
- Relieves minor aches and pains
- Fever reducer
- Lasts up to 12 hours
PUSH TO OPEN
Dispense
through
opening
TAMPER EVIDENT UNIT DOSE POUCHES
DO NOT USE IF POUCH IS TORN OR DAMAGED
100 Pouches
1 Tablet per Pouch
DailyMed RxNorm Mappings#
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| NAPROXEN Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20191108 |
DailyMed Product Concepts#
| 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 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 61010-4410-0 | 2024-01-30 | C162847 | 48780-1 | 1030e365-0fcb-111a-e063-dadaa90a10e2 | 287a381a-df7e-4e93-b097-1efde8a5f120 |
| 61010-4410-1 | 2024-01-30 | C162847 | 48780-1 | 1030e365-0fcb-111a-e063-dadaa90a10e2 | 287a381a-df7e-4e93-b097-1efde8a5f120 |
| 61010-4410-2 | 2024-01-30 | C162847 | 48780-1 | 1030e365-0fcb-111a-e063-dadaa90a10e2 | 287a381a-df7e-4e93-b097-1efde8a5f120 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 61010-4410-0 | Naproxen | 1 in 1 POUCH | TABLET | 1 | 2 | |
| 61010-4410-1 | Naproxen | 50 in 1 CARTON | TABLET | 50 | 2 | |
| 61010-4410-2 | Naproxen | 100 in 1 CARTON | TABLET | 100 | 2 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 61010-4410 | NAPROXEN (NAPROXEN SODIUM) TABLET [SAFETEC OF AMERICA, INC.] | 2 | Legacy NDC, 3 package rows | 20200125_287a381a-df7e-4e93-b097-1efde8a5f120.zip |
Products#
Every source-derived product name is available through these pages.
- Naproxen
- Naproxen Sodium
- Microcrystalline Cellulose
- Starch, Corn
- Sodium Starch Glycolate Type A Potato
- Povidone K30
- Water
- Stearic acid
- HYPROMELLOSES
- POLYETHYLENE GLYCOL 400
- TITANIUM DIOXIDE
- FD&C BLUE NO. 2
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 61010-4410 | 61010-4410-0, 61010-4410-1, 61010-4410-2 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| Naproxen Sodium | 9TN87S3A3C | ACTIB |
| Microcrystalline Cellulose | OP1R32D61U | IACT |
| Starch, Corn | O8232NY3SJ | IACT |
| Sodium Starch Glycolate Type A Potato | 5856J3G2A2 | IACT |
| Povidone K30 | U725QWY32X | IACT |
| Water | 059QF0KO0R | IACT |
| Stearic acid | 4ELV7Z65AP | IACT |
| HYPROMELLOSES | 3NXW29V3WO | IACT |
| POLYETHYLENE GLYCOL 400 | B697894SGQ | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
| FD&C BLUE NO. 2 | L06K8R7DQK | IACT |
Source Document#
Orange Book application contexts#
All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
Orange Book products#
| 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 Orange Book product history#
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 cross-check#
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 |
|---|---|---|---|---|---|---|
| f8ad2d5e-1cc7-46b3-8579-21bedd2c5d6e | 287a381a-df7e-4e93-b097-1efde8a5f120 | 2020-01-20 | Warnings | f8ad2d5e-1cc7-46b3-8579-21bedd2c5d6e 287a381a-df7e-4e93-b097-1efde8a5f120 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.