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 Caplets
- Manufacturer
- Allegiant Health
- Effective date
- 2019-06-06
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 3
- Source
- full-release
- Hydrated at
- 2026-05-31 23:39:50
Label at a glance#
ProductNaproxen Caplets
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 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
Contacts and useful links#
Label contents#
Full prescribing information#
Active ingredient
Naproxen sodium 220mg
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.
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 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
under a doctor’s care for any serious condition
- taking aspirin for heart attack or stroke, because naproxen may
decrease this benefit of aspirin - 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
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
- redness or swelling is present in the painful area
- any new symptoms appear
Pregnancy/Breastfeeding
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.
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
- store at 20° to 25°C (68° to 77° F)
- avoid high humidity and excessive heat above 40°C (104°F)
- do not use if tamper evident seal under bottle is broken or missing
Inactive ingredients
corn starch, FD&C blue #2 aluminum lake, hypromellose, microcrystalline cellulose, polyethylene glycol, povidone, purified water, sodium starch glycolate, stearic acid, titanium dioxide
Questions or Comments?
Call 1-888-952-0050
Monday through Friday 9AM- 5PM EST.
Principal Display Panel
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 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 69168-394-24 | Naproxen Caplets | 24 in 1 BOTTLE | TABLET | 24 | 3 | |
| 69168-394-24 | Naproxen Caplets | 1 in 1 CARTON | TABLET | 1 | 3 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- Naproxen Caplets
- Naproxen Sodium 220 mg
- NAPROXEN SODIUM
- NAPROXEN
- STARCH, CORN
- FD&C BLUE NO. 2--ALUMINUM LAKE
- HYPROMELLOSES
- MICROCRYSTALLINE CELLULOSE
- POLYETHYLENE GLYCOL 1000
- POVIDONE
- WATER
- SODIUM STARCH GLYCOLATE TYPE A CORN
- STEARIC ACID
- TITANIUM DIOXIDE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 69168-394 | 69168-394-24 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| NAPROXEN SODIUM | 9TN87S3A3C | ACTIB |
| STARCH, CORN | O8232NY3SJ | IACT |
| FD&C BLUE NO. 2--ALUMINUM LAKE | 4AQJ3LG584 | IACT |
| HYPROMELLOSES | 3NXW29V3WO | IACT |
| MICROCRYSTALLINE CELLULOSE | OP1R32D61U | IACT |
| POLYETHYLENE GLYCOL 1000 | U076Q6Q621 | IACT |
| POVIDONE | FZ989GH94E | IACT |
| WATER | 059QF0KO0R | IACT |
| SODIUM STARCH GLYCOLATE TYPE A CORN | AG9B65PV6B | IACT |
| STEARIC ACID | 4ELV7Z65AP | 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 |
|---|---|---|---|---|---|---|---|
| A090545-001 | NAPROXEN SODIUM | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2011-03-16 |
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 | A090545-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2011-03-16 | c2088c7a36db… | ||
| 2026-09-14 22:38:34 | 2026-08 | A090545-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2011-03-16 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A090545-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2011-03-16 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A090545-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2011-03-16 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090545-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2011-03-16 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A090545-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2011-03-16 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090545-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2011-03-16 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090545-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2011-03-16 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090545-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2011-03-16 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090545-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2011-03-16 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090545-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2011-03-16 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090545-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2011-03-16 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A090545-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2011-03-16 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090545-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2011-03-16 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A090545-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2011-03-16 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A090545-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2011-03-16 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A090545-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2011-03-16 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A090545-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2011-03-16 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A090545-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2011-03-16 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A090545-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2011-03-16 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A090545-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2011-03-16 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A090545-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2011-03-16 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A090545-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2011-03-16 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A090545-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2011-03-16 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A090545-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2011-03-16 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A090545-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2011-03-16 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A090545-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2011-03-16 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A090545-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2011-03-16 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A090545-001 | NAPROXEN SODIUM | EQ 200MG BASE | TABLET / ORAL | 2011-03-16 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A090545-001 | NAPROXEN SODIUM | EQ 200MG BASE | TABLET / ORAL | 2011-03-16 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A090545-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2011-03-16 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A090545-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2011-03-16 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A090545-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2011-03-16 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A090545-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2011-03-16 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A090545-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2011-03-16 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A090545-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2011-03-16 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A090545-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2011-03-16 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A090545-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2011-03-16 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A090545-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2011-03-16 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A090545-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2011-03-16 | 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 |
|---|---|---|---|---|---|---|
| Naproxen Caplets | NAPROXEN SODIUM 220 MG | Allegiant Health | 07120764-7c33-4c07-9367-40956d970c60 | 2019-06-06 | Warnings | 69168-394-24 69168-394 69168039424 f6b88aa9-7608-49e8-9841-2cf702715869 07120764-7c33-4c07-9367-40956d970c60 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.