Indications and uses
_ temporarily relieves minor aches and pains due to: _ toothache _ muscular aches _ the common cold _ headache _ menstrual cramps _ backache _ minor pain of arthritis _ temporarily reduces fever Drug Facts (continued)
Naproxen Sodium Caplets
- Manufacturer
- Breeden Brothers, LLC
- Effective date
- 2017-02-01
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-05-31 22:53:35
Label at a glance#
ProductNaproxen Sodium Caplets
Active ingredientNAPROXEN SODIUM
Label structure10 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 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 ...
Contacts and useful links#
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Drug Facts
Active ingredient (in each caplet)
Naproxen sodium 220 mg (naproxen 200 mg) (NSAID)*
*nonsteroidal anti-inflammatory drug
Purpose
Pain reliever/fever reducer *nonsteroidal anti-inflammatory drug
Uses
_ temporarily relieves minor aches and pains due to:
_ toothache _ muscular aches _ the common cold
_ headache _ menstrual cramps
_ backache _ minor pain of arthritis
_ temporarily reduces fever
Drug Facts (continued)
Warnings
Allergy alert: Naproxen sodium may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:
_ asthma (wheezing) _ skin reddening _ shock
_ blisters _ rash _ facial swelling _ hives
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 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 a blood thinning (anticoagulant) or steroid drug
_ take more or for a longer time than directed
Drug Facts (continued)
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 have asthma
_ you have problems or serious side effects from taking pain relievers or fever reducers
_ you are taking a diuretic
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
Drug Facts (continued)
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 (1-800-222-1222) right away.
Drug Facts (continued)
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 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
Other information
_ each caplet contains: sodium 20 mg
_ TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
_ store at 20°-25°C (68°-77°F). Avoid high humidity and excessive heat above 40°C (104°F)
_ use by expiration date on package
Drug Facts (continued)
Inactive ingredients
croscarmellose sodium, FD&C blue #2 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, talc, titanium dioxide
Questions or comments?
1-800-901-2420
Dist. by Breeden Brothers, LLC
Nashville, TN 37219
PRINCIPAL DISPLAY PANEL
b+b
better by giving
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 |
| 594e2c86-3079-4e6e-96c9-48f7a8afc78d | Product name | 1 | 20230718 |
| 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 |
|---|---|---|---|---|---|
| 70729-003-24 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-f2f8-f424-e053-dadaa90a57ce | Naproxen Sodium Caplets |
| 70729-003-50 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-f2f8-f424-e053-dadaa90a57ce | Naproxen Sodium Caplets |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 70729-003-24 | Naproxen Sodium Caplets | 24 in 1 BOTTLE, PLASTIC | TABLET | 24 | 1 | |
| 70729-003-50 | Naproxen Sodium Caplets | 50 in 1 BOTTLE, PLASTIC | TABLET | 50 | 1 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- Naproxen Sodium Caplets
- Naproxen sodium
- NAPROXEN
- CROSCARMELLOSE SODIUM
- FD&C BLUE NO. 2
- MAGNESIUM STEARATE
- CELLULOSE, MICROCRYSTALLINE
- POLYETHYLENE GLYCOLS
- POLYVINYL ALCOHOL, UNSPECIFIED
- POVIDONE
- SILICON DIOXIDE
- TALC
- TITANIUM DIOXIDE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 70729-003 | 70729-003-24, 70729-003-50 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| NAPROXEN SODIUM | 9TN87S3A3C | ACTIM |
| CROSCARMELLOSE SODIUM | M28OL1HH48 | IACT |
| FD&C BLUE NO. 2 | L06K8R7DQK | IACT |
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| CELLULOSE, MICROCRYSTALLINE | OP1R32D61U | IACT |
| POLYETHYLENE GLYCOLS | 3WJQ0SDW1A | IACT |
| POLYVINYL ALCOHOL, UNSPECIFIED | 532B59J990 | IACT |
| POVIDONE | FZ989GH94E | IACT |
| SILICON DIOXIDE | ETJ7Z6XBU4 | IACT |
| TALC | 7SEV7J4R1U | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | 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 |
|---|---|---|---|---|---|---|---|
| A204872-001 | NAPROXEN SODIUM | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2017-01-23 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | A204872-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2017-01-23 | c2088c7a36db… | ||
| 2026-09-14 22:38:34 | 2026-08 | A204872-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2017-01-23 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A204872-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2017-01-23 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A204872-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2017-01-23 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204872-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2017-01-23 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A204872-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2017-01-23 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204872-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2017-01-23 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204872-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2017-01-23 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204872-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2017-01-23 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204872-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2017-01-23 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204872-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2017-01-23 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A204872-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2017-01-23 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A204872-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2017-01-23 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A204872-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2017-01-23 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A204872-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2017-01-23 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A204872-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2017-01-23 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A204872-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2017-01-23 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A204872-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2017-01-23 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A204872-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2017-01-23 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A204872-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2017-01-23 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A204872-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2017-01-23 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A204872-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2017-01-23 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A204872-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2017-01-23 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A204872-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2017-01-23 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A204872-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2017-01-23 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A204872-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2017-01-23 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A204872-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2017-01-23 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A204872-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2017-01-23 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A204872-001 | NAPROXEN SODIUM | EQ 200MG BASE | TABLET / ORAL | 2017-01-23 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A204872-001 | NAPROXEN SODIUM | EQ 200MG BASE | TABLET / ORAL | 2017-01-23 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A204872-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2017-01-23 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A204872-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2017-01-23 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A204872-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2017-01-23 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A204872-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2017-01-23 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A204872-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2017-01-23 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A204872-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2017-01-23 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A204872-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2017-01-23 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A204872-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2017-01-23 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A204872-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2017-01-23 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A204872-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2017-01-23 | 3a93d1ddd44b… |
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 |
|---|---|---|---|---|---|---|
| d8959e17-0c78-4619-90ae-9510e6c9d0e2 | 04c73d7b-ca24-45da-a395-d3b30f6c7b1e | 2017-02-01 | Warnings | d8959e17-0c78-4619-90ae-9510e6c9d0e2 04c73d7b-ca24-45da-a395-d3b30f6c7b1e |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.