FDA Label for All Day Pain Relief

View Indications, Usage & Precautions

All Day Pain Relief Product Label

The following document was submitted to the FDA by the labeler of this product We Care Distributor Inc.. 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 - Purpose



Active ingredients (in each tablet)Purposes
Naproxen Sodium 220 mg 
(naproxen 200 mg) (NSAID)

*

Pain reliever/fever reducer

*nonsteroidal anti-inflammatory drug


Uses



■ temporarily relieves minor aches and pains due to:

  ■ minor pain of arthritis ■ muscular aches ■ backache ■ headache

  ■ menstrual cramps ■ toothache ■ the 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



■ 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


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 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


Otc - Pregnancy Or Breast Feeding



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.


Otc - Keep Out Of Reach Of Children



Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.


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

  ■ take 1 tablet every 8 to 12 hours while symptoms last 12 years and older

  ■ 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 (68-77°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?



1-888-705-WECARE (Mon-Fri 9am-5pm EST) or www.wecaredistributor.com


Principal Display Panel



See New Warnings Information & Directions

Compare to the Active Ingredients in Aleve®.

ALL DAY PAIN RELIEF

Naproxen Sodium Tablets, 220 mg

TO OPEN
PUSH IN TAB AND PULL OUT

25 Pouches of 2 Caplets Each


* Please review the disclaimer below.