Medique at Home Mediproxen
- Manufacturer
- Unifirst First Aid Corporation | Medique Products
- Effective date
- 2025-09-09
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 7
- Source
- full-release
- Hydrated at
- 2026-06-01 01:13:18
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Drug Facts
OTC - ACTIVE INGREDIENT SECTION
Active ingredient (in each tablet)
Naproxen Sodium USP, 220 mg
(naproxen 200 mg) (NSAID*)
* nonsteroidal anti-inflammatory drug
OTC - PURPOSE SECTION
Purpose
Pain reliever/fever reducer
INDICATIONS & USAGE SECTION
Uses
■ temporarily relieves minor aches and pains due to: ■ backache ■ muscular aches ■ minor pain of arthritis ■ menstrual cramps
■ headache ■ toothache ■ the common cold
temporarily reduces fever
WARNINGS SECTION
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 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: NSAID, 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.
OTC - DO NOT USE SECTION
Do not use
■ if you have ever had an allergic reaction to any other pain reliever/fever reducer
■ right before or after heart surgery
OTC - ASK DOCTOR SECTION
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, 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
OTC - ASK DOCTOR/PHARMACIST SECTION
Ask a doctor or pharmacist before use if you are
■ 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
OTC - WHEN USING SECTION
When using this product
■ take with food or milk if stomach upset occurs
OTC - STOP USE SECTION
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 for more than 10 days
■ fever gets worse or lasts for 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
OTC - PREGNANCY OR BREAST FEEDING SECTION
If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use naproxen sodium at 20 weeks or later in pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away.
DOSAGE & ADMINISTRATION SECTION
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 SAFETY INFORMATION
Other information
■ each tablet contains: sodium 20 mg
■ store at 68-77ºF (20-25ºC)
■ avoid high humidity and excessive heat above 104ºF (40ºC)
■ Tamper Evident child resistant packets
■ do not use any open or torn packets
INACTIVE INGREDIENT SECTION
Inactive ingredients
croscarmellose sodium, FD&C blue #2, macrogol, magnesium stearate, polyvinyl alcohol, povidone, pregelatinized starch, talc, titanium dioxide
OTC - QUESTIONS SECTION
Questions or comments? 1-800-634-7680
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Medique® @ Home
Mediproxen
Naproxen Sodium 220 mg
Pain Reliever/Fever Reducer
(NSAID)
Pull to Open
Child-Resistant Packets
*not actual size
50 Packets
(1 Tablet Per Packet)
Compare to the active ingredient in Aleve® Tablets
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 |
|---|---|---|---|---|---|---|
| 47682-737-46 | Medique at Home Mediproxen | 1 in 1 PACKET | TABLET, FILM COATED | 1 | 7 | |
| 47682-737-50 | Medique at Home Mediproxen | 50 in 1 BOX | TABLET, FILM COATED | 50 | 7 |
Products#
Every source-derived product name is available through these pages.
- Medique at Home Mediproxen
- Naproxen Sodium
- STARCH, CORN
- POLYETHYLENE GLYCOL, UNSPECIFIED
- TITANIUM DIOXIDE
- MAGNESIUM STEARATE
- POLYVINYL ALCOHOL, UNSPECIFIED
- TALC
- FD&C BLUE NO. 2
- POVIDONE
- NAPROXEN
- CROSCARMELLOSE SODIUM
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 47682-737 | 47682-737-46, 47682-737-50 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| STARCH, CORN | O8232NY3SJ | IACT |
| POLYETHYLENE GLYCOL, UNSPECIFIED | 3WJQ0SDW1A | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| POLYVINYL ALCOHOL, UNSPECIFIED | 532B59J990 | IACT |
| TALC | 7SEV7J4R1U | IACT |
| FD&C BLUE NO. 2 | L06K8R7DQK | IACT |
| POVIDONE | FZ989GH94E | IACT |
| NAPROXEN SODIUM | 9TN87S3A3C | ACTIB |
| CROSCARMELLOSE SODIUM | M28OL1HH48 | 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 |
|---|---|---|---|---|---|---|---|
| A079096-001 | NAPROXEN SODIUM | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2008-12-16 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A079096-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2008-12-16 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A079096-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2008-12-16 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A079096-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2008-12-16 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A079096-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2008-12-16 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A079096-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2008-12-16 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A079096-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2008-12-16 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A079096-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2008-12-16 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A079096-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2008-12-16 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A079096-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2008-12-16 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A079096-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2008-12-16 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A079096-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2008-12-16 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A079096-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2008-12-16 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A079096-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2008-12-16 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A079096-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2008-12-16 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A079096-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2008-12-16 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A079096-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2008-12-16 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A079096-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2008-12-16 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A079096-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2008-12-16 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A079096-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2008-12-16 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A079096-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2008-12-16 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A079096-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2008-12-16 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A079096-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2008-12-16 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A079096-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2008-12-16 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A079096-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2008-12-16 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A079096-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2008-12-16 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A079096-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2008-12-16 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A079096-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2008-12-16 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A079096-001 | NAPROXEN SODIUM | EQ 200MG BASE | TABLET / ORAL | 2008-12-16 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A079096-001 | NAPROXEN SODIUM | EQ 200MG BASE | TABLET / ORAL | 2008-12-16 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A079096-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2008-12-16 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A079096-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2008-12-16 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A079096-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2008-12-16 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A079096-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2008-12-16 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A079096-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2008-12-16 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A079096-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2008-12-16 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A079096-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2008-12-16 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A079096-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2008-12-16 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A079096-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2008-12-16 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A079096-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2008-12-16 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A079096-001 | NAPROXEN SODIUM | 220MG | TABLET / ORAL | 2008-12-16 | 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 |
|---|---|---|---|---|---|---|
| Medique at Home Mediproxen | NAPROXEN SODIUM | Unifirst First Aid Corporation | b591ba4f-d7d3-4c81-e053-2995a90a7c6e | 2025-09-09 | Warnings | 47682-737-50 47682-737-46 47682-737 47682073746 47682073750 3e5d544f-38be-42a3-e063-6294a90aebbf b591ba4f-d7d3-4c81-e053-2995a90a7c6e |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
