The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.
Otc - Active Ingredient
Active ingredient (in each tablet)Naproxen Sodium USP, 220 mg (naproxen 200 mg) (NSAID)** nonsteroidal anti-inflammatory drug
Otc - Purpose
PurposePain reliever/fever reducer
Indications & Usage
Uses■ temporarily relieves minor aches and pains due to: ■ backache ■ muscular aches ■ minor pain of arthritis ■ menstrual cramps■ headache ■ toothache ■ the common cold■ temporarily reduces fever
WarningsAllergy 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■ blistersIf 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 directedHeart attack and stroke warning: NSAID, 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.
Otc - Do Not Use
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
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
Ask a doctor or pharmacist before use if you are■ under a doctor’s care for any serious condition■ taking aspirin for heart attack or stroke, because naproxen may decrease this benefit of aspirin■ taking any other drug
Otc - When Using
When using this product■ take with food or milk if stomach upset occurs
Otc - Stop Use
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■ you have symptoms of heart problems or stroke: ■ chest pain ■ trouble breathing ■ weakness in one part or side of body ■ slurred speech ■ leg swelling■ pain gets worse or lasts for more than 10 days■ fever gets worse or lasts for 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 right away.
Dosage & Administration
do not take more than directed■ the smallest effective dose should be used■ drink a full glass of water with each doseAdults 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 to 12 hour period■ do not exceed 3 tablets in a 24-hour periodChildren under 12 years: ■ ask a doctor
Other Safety Information
Other information■ each tablet contains: sodium 20 mg■ store at 68-77ºF (20-25ºC)■ avoid high humidity and excessive heat above 104ºF (40ºC)■
Tamper Evident child resistant packets
■ do not use any open or torn packets
Inactive ingredientscroscarmellose sodium, FD&C blue #2, macrogol, magnesium stearate, polyvinyl alcohol, povidone, pregelatinized starch, talc, titanium dioxide
Otc - Questions
Questions or comments? 1-800-634-7680
* Please review the disclaimer below.