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
Perrigo Naproxen Sodium Tablets 220 mg Drug Facts
- Manufacturer
- NuCare Pharmaceuticals, Inc.
- Effective date
- 2016-11-09
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- legacy-cache
- Hydrated at
- 2026-08-02 01:21:35
Label at a glance#
ProductNaproxen Sodium
Active ingredientNAPROXEN SODIUM
Label structure9 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 under 12 years: ask a doctor
Storage and handling
each tablet contains: sodium 21 mg store at 20-25°C (68-77°F). Avoid high humidity and excessive heat above 40°C (104°F).
Contacts and useful links#
Label contents#
Full prescribing information#
Active ingredient (in each tablet)
Naproxen sodium 220 mg
(naproxen 200 mg) (NSAID)*
*nonsteroidal anti-inflammatory drug
Purpose
Pain reliever/fever reducer
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
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
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 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
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
- the risk of heart attack or stroke may increase if you use more than directed or for longer than directed
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
- 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 right away. (1-800-222-1222)
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:
- 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
Other information
- each tablet contains: sodium 21 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 no. 2 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, talc, titanium dioxide
Questions or comments?
1-800-719-9260
Principal Display Panel
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 66267-343-21 | 2020-02-19 | C162847 | 48780-1 | 9d75b9d0-6139-f424-e053-dadaa90a57ce | Perrigo Naproxen Sodium Tablets 220 mg Drug Facts |
| 66267-343-30 | 2020-02-19 | C162847 | 48780-1 | 9d75b9d0-6139-f424-e053-dadaa90a57ce | Perrigo Naproxen Sodium Tablets 220 mg Drug Facts |
| 66267-343-21 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-6139-f424-e053-dadaa90a57ce | Perrigo Naproxen Sodium Tablets 220 mg Drug Facts |
| 66267-343-30 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-6139-f424-e053-dadaa90a57ce | Perrigo Naproxen Sodium Tablets 220 mg Drug Facts |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 66267-343-30 | EA - Each | 66267-343 | dfc2260b-de86-4a68-a745-fbb0b6c20f69 | 1 | 2016-12-07 |
| 45802-490-71 | EA - Each | 45802-490 | 6e13e229-b6e3-4a4e-92eb-0274a25ab116 | 1 | 2014-05-02 |
| 45802-490-75 | EA - Each | 45802-490 | bf4f309b-068b-4f42-9f1c-27383cde6e7d | 1 | 2022-09-12 |
| 45802-490-78 | EA - Each | 45802-490 | 1334b523-b384-45fb-8001-849665fc264d | 1 | 2014-05-02 |
Products#
Every source-derived product name is available through these pages.
- Naproxen Sodium
- HYPROMELLOSES
- MAGNESIUM STEARATE
- CELLULOSE, MICROCRYSTALLINE
- POLYETHYLENE GLYCOLS
- POVIDONES
- TALC
- TITANIUM DIOXIDE
- NAPROXEN
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 66267-343 | 66267-343-30, 66267-343-21 |
| 45802-490 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| HYPROMELLOSES | 3NXW29V3WO | IACT |
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| CELLULOSE, MICROCRYSTALLINE | OP1R32D61U | IACT |
| POLYETHYLENE GLYCOLS | 3WJQ0SDW1A | IACT |
| POVIDONES | FZ989GH94E | IACT |
| TALC | 7SEV7J4R1U | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
| NAPROXEN SODIUM | 9TN87S3A3C | ACTIB |
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 |
|---|---|---|---|---|---|---|---|
| A074661-001 | NAPROXEN SODIUM | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 1997-01-13 |
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 | A074661-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 1997-01-13 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A074661-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 1997-01-13 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A074661-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 1997-01-13 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A074661-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 1997-01-13 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A074661-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 1997-01-13 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A074661-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 1997-01-13 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A074661-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 1997-01-13 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A074661-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 1997-01-13 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A074661-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 1997-01-13 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A074661-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 1997-01-13 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A074661-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 1997-01-13 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A074661-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 1997-01-13 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A074661-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 1997-01-13 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A074661-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 1997-01-13 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A074661-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 1997-01-13 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A074661-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 1997-01-13 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A074661-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 1997-01-13 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A074661-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 1997-01-13 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A074661-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 1997-01-13 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A074661-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 1997-01-13 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A074661-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 1997-01-13 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A074661-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 1997-01-13 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A074661-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 1997-01-13 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A074661-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 1997-01-13 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A074661-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 1997-01-13 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A074661-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 1997-01-13 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A074661-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 1997-01-13 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A074661-001 | NAPROXEN SODIUM | EQ 200MG BASE | TABLET / ORAL | 1997-01-13 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A074661-001 | NAPROXEN SODIUM | EQ 200MG BASE | TABLET / ORAL | 1997-01-13 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A074661-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 1997-01-13 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A074661-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 1997-01-13 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A074661-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 1997-01-13 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A074661-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 1997-01-13 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A074661-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 1997-01-13 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A074661-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 1997-01-13 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A074661-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 1997-01-13 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A074661-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 1997-01-13 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A074661-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 1997-01-13 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A074661-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 1997-01-13 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A074661-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 1997-01-13 | 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 |
|---|---|---|---|---|---|---|
| Naproxen Sodium | NAPROXEN SODIUM | Padagis Israel Pharmaceuticals Ltd | cdb60f74-ce23-4015-90eb-b23a2275f6cb | 2026-02-11 | Warnings | 45802-490 |
| 40e38f84-2fcc-0e9b-e054-00144ff8d46c | 40e38f84-2fcb-0e9b-e054-00144ff8d46c | 2016-11-09 | Warnings | 40e38f84-2fcc-0e9b-e054-00144ff8d46c 40e38f84-2fcb-0e9b-e054-00144ff8d46c |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.