Active Ingredients And Purpose
Active ingredient
(in each tablet) Naproxen sodium 220 mg (NSAID)** **nonsteroidal anti-inflammatory drug
Purposes
Pain reliever/fever reducer
Naproxen Sodium Tablets USP 220mg (Round)
- Manufacturer
- Pharmacy Valuce Alliance, LLC
- Effective date
- 2021-01-29
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 4
- Source
- full-release
- Hydrated at
- 2026-05-31 23:37:35
Key Label Information#
Uses
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
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.
Directions And Dosage
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 Label Information
Inactive ingredients
FD&C blue #2 aluminum lake, hypromellose 2910, maize starch, microcrystalline cellulose, polyethylene glycol, povidone k-30, sodium starch glycolate, stearic acid, titanium dioxide.
Questions or comments?
1-877-770-3183 Mon-Fri 9:00 AM to 4:00 PM EST.
Label Images#
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 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 68016-661-05 | 2023-01-30 | C162847 | 48780-1 | f386c649-cbf4-0266-e053-dadaa90a7c1a | Naproxen Sodium Tablets USP 220mg (Round) |
| 68016-661-10 | 2023-01-30 | C162847 | 48780-1 | f386c649-cbf4-0266-e053-dadaa90a7c1a | Naproxen Sodium Tablets USP 220mg (Round) |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68016-661-05 | Naproxen Sodium | 50 in 1 BOTTLE | TABLET | 50 | 4 | |
| 68016-661-10 | Naproxen Sodium | 100 in 1 BOTTLE | TABLET | 100 | 4 |
DailyMed Dashboard NDC Coverage#
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 68016-661-05 | EA - Each | 68016-661 | c59ebbb4-2f0d-4183-8bbd-0c089bbfcb68 | 1 | 2022-06-06 |
| 68016-661-10 | EA - Each | 68016-661 | 268ac862-ecfb-4e37-bd68-18fa02818fd1 | 1 | 2022-06-06 |
Products#
- NAPROXEN
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 68016-661 | 68016-661-10, 68016-661-05 |
Ingredients#
Complete SPL Sections#
Active ingredient
(in each tablet) Naproxen sodium 220 mg (NSAID)** **nonsteroidal anti-inflammatory drug
Purposes
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, 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
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
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 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 the reach of children.
In case of overdose, get medical help or contact a Poison Control Center 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 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 20 mg store at 20 - 25°C (68 to 77°F). Avoid high humidity and excessive heat above 40°C (104°F)
Inactive ingredients
FD&C blue #2 aluminum lake, hypromellose 2910, maize starch, microcrystalline cellulose, polyethylene glycol, povidone k-30, sodium starch glycolate, stearic acid, titanium dioxide.
Questions or comments?
1-877-770-3183 Mon-Fri 9:00 AM to 4:00 PM EST.