FDA Label for Naproxen Sodium
View Indications, Usage & Precautions
- OTHER
- OTC - ACTIVE INGREDIENT
- OTC - PURPOSE
- USES
- WARNINGS
- ALLERGY ALERT
- STOMACH BLEEDING WARNING
- HEART ATTACK AND STROKE WARNING
- DO NOT USE
- ASK A DOCTOR BEFORE USE IF
- ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
- WHEN USING THIS PRODUCT
- STOP USE AND ASK A DOCTOR IF
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- OTC - QUESTIONS
- PRICNIPAL DISPLAY PANEL
Naproxen Sodium Product Label
The following document was submitted to the FDA by the labeler of this product Spirit 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.
Other
Drug Facts
Otc - Active Ingredient
Naproxen sodium 220 mg
(naproxen 200 mg) (NSAID)**
**nonsteroidal anti-inflammatory drug
Otc - Purpose
Pain reliever/
fever reducer
Uses
- temporarily relieves minor aches and pain due to :
- backache
- headache
- menstrul cramps
- minor pain of arthritis
- muscular aches
- the common cold
- toothache
- temporarily reduces fever
Warnings
Warnings
Allergy Alert
Naproxen sodium may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:
- asthma (wheezing)
- blisters
- facial swelling
- hives
- rash
- shock
- skin reddening
If an allergic reaction occurs, stop use and seek medical help right away.
Stomach Bleeding Warning
This product contains a non steroidal anti-inflammatory drug(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
NSAID's except aspirin increases 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 surgery
Ask A Doctor Before Use If
- the stomach bleeding warning applies to you
- you have a history of stomach problems,such as a 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 conditions
- taking any other drug
- taking aspirin for heart attack or stroke, because
- naproxen may decrease this benefit of aspirin
When Using This Product
- take with food or milk if stomach upset occurs
Stop Use And Ask A Doctor If
- you experience any of following sign 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 feel 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
If pregnant or breast feeding, ask a health profession 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 complication during the delivery.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. In case of overdose, get medical help or contact a position control center right away (1-800-222-1222)
Directions
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Adults and Children 12 years and older: |
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Children under 12 years: |
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Other Information
each tablet contains: sodium 20 mg
store between 20°-25°C(68-77°F). Avoid high humidity and excessive heat above 40°C(104°F)
Inactive Ingredients
colloidal silicon dioxide*,croscarmellose sodium*, FD&C Blue#2 lake,hypromellose, magnesium stearate*, maize starch*, microcrystalline cellulose, polyethylene glycol, povidone, sodium starch glycolate*,stearic acid*, titanium dioxide.
*contains one or more of these ingredients
Otc - Questions
Questions or comments?
1-888-333-9792
Pricnipal Display Panel
Compare to the active
ingredient in Aleve®†
ALL DAY
PAIN RELIEF
NAPROXEN SODIUM TABLETS, USP 220 mg
PAIN RELIEVER/FEVER REDUCER (NSAID)
* Please review the disclaimer below.