FDA Label for Naproxen All Day Relief For Pain

View Indications, Usage & Precautions

Naproxen All Day Relief For Pain Product Label

The following document was submitted to the FDA by the labeler of this product Allegiant Health. 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



Naproxen sodium 220mg
(naproxen 200mg) (NSAID)*
*nonsteroidal anti-inflammatory drug


Purpose



Pain reliever/fever reducer


Uses



temporarily relieves minor aches and pains due to: ■ minor pain of arthritis ■ backache ■ headache ■ muscular aches ■ menstrual cramps ■ toothache ■ common cold ■ temporarily reduces fever


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


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



■ 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 You Are



under a doctors care for any serious condition taking any other drug


When Using This Product



take with food or milk if stomach upset occursthe 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 immediately


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 8-12 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 20mg store at 20-25 °C (68-77° F).■ avoid high humidity and excessive heat above 40 °C (104° F).Do not use if tamper evident seal under bottle cap is broken or missing.


Inactive Ingredients



colloidal silicon dioxide, croscarmellose sodium, FD&C Blue #2 lake, hypromellose, magnesium
stearate, microcrystalline cellulose, polyethylene glycol, povidone, titanium dioxide


* Please review the disclaimer below.