Storage and handling
■ 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) ■ see end flap for expiration date and lot number
■ 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) ■ see end flap for expiration date and lot number
Naproxen sodium 220 mg (naproxen 200 mg) (NSAID)*
*nonsteroidal anti-inflammatory drug
Pain reliever/ fever reducer
Uses ■ temporarily relieves minor aches and pain due to: ■ headache ■ muscular aches ■ toothache ■ the common cold ■ backache ■ menstrual cramps ■ minor pain of arthritis
■ temporarily reduces fever
Allergy alert: Naproxen sodium may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: ■ shock ■ facial swelling ■ asthma (wheezing) ■ hives ■ skin reddening ■ blisters ■ rash
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
■ have had stomach ulcers or bleeding problems
■ take blood thinning (anticoagulant) or steroid drug
■ are age 60 or older
■ take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]
■ take more or for a longer time than directed
■ have 3 or more alcoholic drinks every day while using this product.
Do not use ■ right before or after heart surgery ■ if you have ever had an allergic reaction to any other pain reliever/fever reducer
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 asthma
■ you have high blood pressure, heart disease, liver cirrhosis or kidney disease
■ you have a 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
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.
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 to12 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
■ 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)
■ see end flap for expiration date and lot number
Inactive ingredients colloidal silicon dioxide, FD & C Blue#2 Aluminum Lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, titanium dioxide, talc
Call 1-888-779-2877 M-F 9AM-5PM EST
For toothaches
KEEP OUTER PACKAGE FOR COMPLETE PRODUCT INFORMATION
Distributed by Belmora LLC, 2011 Crystal Dr. Suite 400 Arlington, VA 22202
Made in India
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
| 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 |
| 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 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 27854-701-01 | Ana-Dent PAIN RELIEF | 1 in 1 CARTON | TABLET, FILM COATED | 1 | 1 | |
| 27854-701-01 | Ana-Dent PAIN RELIEF | 24 in 1 BOTTLE | TABLET, FILM COATED | 24 | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 27854-701 | 27854-701-01 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| NAPROXEN SODIUM | 9TN87S3A3C | ACTIM |
| SILICON DIOXIDE | ETJ7Z6XBU4 | IACT |
| FD&C BLUE NO. 2 | L06K8R7DQK | IACT |
| HYPROMELLOSE 2910 (5 MPA.S) | R75537T0T4 | IACT |
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| MICROCRYSTALLINE CELLULOSE | OP1R32D61U | IACT |
| POLYETHYLENE GLYCOL 8000 | Q662QK8M3B | IACT |
| POVIDONE K30 | U725QWY32X | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
| TALC | 7SEV7J4R1U | IACT |
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 |
|---|---|---|---|---|---|---|---|
| A205497-001 | NAPROXEN SODIUM | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2016-03-18 |
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 | A205497-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2016-03-18 | c2088c7a36db… | ||
| 2026-09-14 22:38:34 | 2026-08 | A205497-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2016-03-18 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A205497-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2016-03-18 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A205497-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2016-03-18 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A205497-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2016-03-18 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A205497-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2016-03-18 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A205497-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2016-03-18 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A205497-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2016-03-18 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A205497-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2016-03-18 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A205497-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2016-03-18 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A205497-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2016-03-18 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A205497-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2016-03-18 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A205497-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2016-03-18 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A205497-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2016-03-18 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A205497-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2016-03-18 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A205497-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2016-03-18 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A205497-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2016-03-18 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A205497-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2016-03-18 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A205497-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2016-03-18 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A205497-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2016-03-18 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A205497-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2016-03-18 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A205497-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2016-03-18 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A205497-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2016-03-18 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A205497-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2016-03-18 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A205497-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2016-03-18 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A205497-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2016-03-18 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A205497-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2016-03-18 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A205497-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2016-03-18 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A205497-001 | NAPROXEN SODIUM | EQ 200MG BASE | TABLET / ORAL | 2016-03-18 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A205497-001 | NAPROXEN SODIUM | EQ 200MG BASE | TABLET / ORAL | 2016-03-18 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A205497-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2016-03-18 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A205497-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2016-03-18 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A205497-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2016-03-18 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A205497-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2016-03-18 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A205497-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2016-03-18 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A205497-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2016-03-18 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A205497-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2016-03-18 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A205497-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2016-03-18 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A205497-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2016-03-18 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A205497-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2016-03-18 | 3a93d1ddd44b… |
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 |
|---|---|---|---|---|---|---|
| Ana-Dent PAIN RELIEF | NAPROXEN SODIUM | Belmora LLC | 04721306-2850-4e0a-9dd9-7cabb575f3c7 | 2020-05-18 | Warnings | 27854-701-01 27854-701 27854070101 5ac02446-13da-43d5-9647-fe469294acec 04721306-2850-4e0a-9dd9-7cabb575f3c7 |
Adverse event summaries are temporarily unavailable. Other product information remains available.