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
Adults and children 12 years and over ■ 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 hr 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 ■ muscular aches
■ backache ■ menstrual cramps
■ headache ■ toothache
■ the common cold
■ temporarily reduces fever
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.
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.
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.
■ 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
■ 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 of swelling is present in the painful area
■ any new symptoms appear
You may report side effects to FDA at 1-800-FDA-1088
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.
In case of overdose, get medical help or contact a Poison Control Center right away.
Adults and children 12 years and over
■ 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 hr period
Children under 12 years
■ ask a doctor
■ each tablet contains: sodium 20mg
■ store at 20 to 250C (68 to 770F). Avoid high
humidity and excessive heat above 400C (1040F).
Polyvinyl Pyrolidone, Microcrystalline Cellulose, Starch 1500, Sodium Starch Glycolate, Talc, Magnesium Stearate, FD&C Blue #2, Purified Water, Polysorbate 80, Titanium Dioxide, Polyethylene Glycol, Hypromellose
Call 1-732-698-5070 Monday through Friday 9AM–5PM EST or
www.pioneerlifesciences.com
■ if you have ever had an allergic reaction to
any other pain reliever/fever reducer
■ right before or after heart surgery
■ take with food or milk if stomach upset occurs
| 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 |
|---|---|---|---|---|---|
| 72090-003-01 | 2023-01-30 | C162847 | 48780-1 | f386c649-e604-0266-e053-dadaa90a7c1a | c29fec0c-a858-ef95-e053-2995a90a81d8 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 72090-003-01 | Pain and Fever Relief | 300 in 1 BOTTLE | TABLET | 300 | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 72090-003 | 72090-003-01 |
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 |
|---|---|---|---|---|---|---|
| c29fe377-2308-9b47-e053-2995a90a3846 | c29fec0c-a858-ef95-e053-2995a90a81d8 | 2021-05-18 | Warnings | c29fe377-2308-9b47-e053-2995a90a3846 c29fec0c-a858-ef95-e053-2995a90a81d8 |
Adverse event summaries are temporarily unavailable. Other product information remains available.