FDA Label for Naproxen Sodium
View Indications, Usage & Precautions
- ACTIVE INGREDIENT(S)
- PURPOSE
- USE(S)
- WARNINGS
- DO NOT USE
- ASK A DOCTOR BEFORE USE IF
- ASK A DOCTOR OR PHARMACIST BEFORE USE IF
- WHEN USING THIS PRODUCT
- STOP USE AND ASK DOCTOR IF
- PREGNANCY/BREASTFEEDING
- KEEP OUT OF REACH OF CHILDREN
- DIRECTIONS
- STORAGE
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS
- PRINCIPAL DISPLAY PANEL
Naproxen Sodium Product Label
The following document was submitted to the FDA by the labeler of this product Polygen Pharmaceuticals Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredient(S)
Naproxen Sodium 220 mg (naproxen 200 mg) (NSAID)*
*nonsteroidal anti-inflammatory drug
Purpose
Pain reliever/Fever reducer
Use(S)
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
- 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
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:
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 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 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
- redness or swelling is present in the painful area
- any new symptoms appear
- you have difficulty swallowing
- it feels like the pill is stuck in your throat
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 right away (1-800-222-1222).
Directions
- do not take more than directed
- the smallest effective dose should be used
- drink a full glass of water with each dose
- 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
- ask a doctor
| adults and children 12 years and older: | |
| children under 12 years: |
Storage
store at 20-25°C (68-77°F) avoid high humidity and excessive heat above 40°C (104°F).
Other Information
- each tablet contains: sodium 20 mg
- side effects occur. You may report side effects to PolyGen at 1-888-291-7337 and/ or FDA at 1-800-FDA-1088.
Inactive Ingredients
colloidal silicon dioxide, croscarmellose sodium, FD&C blue #2 lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycols, povidone, titanium dioxide.
Questions Or Comments
1-800-291-7337
Principal Display Panel
NAPROXEN SODIUM TABLETS:
Carton PDP:
NDC: 52605-141-01
Compare to the active ingredient in Aleve®
ALL DAY PAIN RELIEF
NAPROXEN SODIUM TABLETS, USP 220 mg
PAIN RELIEVER/ FEVER REDUCER (NSAID)
STRENGTH TO LAST 12 HOURS
100 TABLETS
Bottle Label PDP:
NDC: 52605-141-01
ALL DAY PAIN RELIEF
NAPROXEN SODIUM TABLETS, USP 220 mg
PAIN RELIEVER/ FEVER REDUCER(NSAID)
STRENGTH TO LAST 12 HOURS
100 TABLETS
NAPROXEN SODIUM CAPLETS:
Carton PDP:
NDC: 52605-144-01
Compare to the active ingredient in Aleve®
ALL DAY PAIN RELIEF
NAPROXEN SODIUM TABLETS, USP 220 mg
PAIN RELIEVER/ FEVER REDUCER (NSAID)
STRENGTH TO LAST 12 HOURS
100 CAPLETS (CAPSULE- SHAPED TABLETS)
Bottle Label PDP:
NDC: 52605-144-01
ALL DAY PAIN RELIEF
NAPROXEN SODIUM TABLETS, USP 220 mg
PAIN RELIEVER/ FEVER REDUCER (NSAID)
STRENGTH TO LAST 12 HOURS
100 CAPLETS (CAPSULE- SHAPED TABLETS)
NAPROXEN SODIUM CAPLETS:
Carton PDP:
NDC: 52605-144-24
Compare to the active ingredient in Aleve®
ALL DAY PAIN RELIEF
NAPROXEN SODIUM TABLETS, USP 220 mg
PAIN RELIEVER/ FEVER REDUCER (NSAID)
STRENGTH TO LAST 12 HOURS
24 CAPLETS (CAPSULE- SHAPED TABLETS)
Bottle Label PDP:
NDC: 52605-144-24
ALL DAY PAIN RELIEF
NAPROXEN SODIUM TABLETS, USP 220 mg
PAIN RELIEVER/ FEVER REDUCER (NSAID)
STRENGTH TO LAST 12 HOURS
24 CAPLETS (CAPSULE- SHAPED TABLETS)
* Please review the disclaimer below.