609R 49483-609 Naproxen Sodium Tablets 220 mg
DRUG FACTS
OTC - ACTIVE INGREDIENT SECTION
Active ingredient (in each tablet) Naproxen sodium 220 mg (naproxen 200 mg) (NSAID)* *nonsteroidal anti-inflammatory drug
OTC - PURPOSE SECTION
Purposes Pain reliever/ Fever reducer
INDICATIONS & USAGE SECTION
Uses temporarily relieves minor aches and pains due to:
temporarily reduces fever
- minor pain of arthritis
- muscular aches
- backache
- menstrual cramps
- headache
- toothache
- the common cold
WARNINGS SECTION
WarningsAllergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:
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:
Heart attack and stroke warning: NSAIDs, except aspirin, increase 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.
- hives
- facial swelling
- asthma (wheezing)
- shock
- skin reddening
- rash
- blisters
OTC - DO NOT USE SECTION
Do not use
- if you have ever had an allergic reaction to any other pain reliever / fever reducer
- right before or after heart surgery
OTC - ASK DOCTOR SECTION
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, 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
OTC - ASK DOCTOR/PHARMACIST SECTION
Ask a doctor or pharmacist before use if you are
- under a doctor's care for any serious condition
- taking any other drug
OTC - WHEN USING SECTION
When using this product
- take with food or milk if stomach upset occurs
OTC - STOP USE SECTION
Stop use and ask a doctor if you experience any of the following signs of stomach bleeding:
you have symptoms of heart problems or stroke:
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
- feel faint
- vomit blood
- have bloody or black stools
- have stomach pain that does not get better
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 (1-800-222-1222)
DOSAGE & ADMINISTRATION SECTION
Directions
adults and children 12 years and older:
children under 12 years:
- do not take more than directed
- the smallest effective dose should be used
- drink a full glass of water with each dose
OTHER INFORMATION
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 INGREDIENT SECTION
Inactive ingredients colloidal silicon dioxide, croscarmellose sodium, FD&C Blue #2 Lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, titanium dioxide.
OTC - QUESTIONS SECTION
Questions or comments call 1-877-290-4008