PROXEN NP 660
SPL UNCLASSIFIED SECTION
Drug Facts
OTC - PURPOSE SECTION
Active ingredient (in each tablet) Purposes
Naproxen sodium 220 mg (naproxen 200mg) (NSAID)* .........Pain reliever/fever reducer
*nonsteroidal anti-inflammatory drug
Uses
■ temporarily relieves minor aches and pains due to:
■ headache ■ backache ■ muscular aches
■ the common cold ■ toothache ■ menstrual cramps
■ minor pain of arthritis ■ temporarily reduces fever
Warnings
Allergy alert:
Naproxen sodium may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:
■ hives ■ asthma (wheezing) ■ skin reddening
■ facial swelling ■ shock ■ 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
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
■ 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
■ side effects occur.
You may report side effects to FDA at 1-800-FDA-1088.
■ 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 SECTION
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 SECTION
Keep out of 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 to12 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)
■ read all product information before using
■ TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER 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