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.
Active Ingredient (In Each Capsule)
Naproxen sodium 220 mg (naproxen 200 mg) (NSAID)* *nonsteroidal anti-inflammatory drug
Pain reliever/fever reducer
- Temporarily relieves minor aches and pains due to:
- Minor pain of arthritis muscular aches backache menstrual cramps headache toothache the common coldtemporarily 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 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 have 3 or more alcoholic drinks every day while using this product take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others) take more or for a longer time than directedHeart attack and stroke: 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.
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, 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
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
Stop Use And Ask A Doctor If
- You experience any of the following signs of stomach bleeding:
- Feel faint have bloody or black stools vomit blood have stomach pain that does not get betteryou have symptoms of heart problems or stroke:
- Chest painslurred speechleg swellingtrouble breathingweakness in one part or side of bodypain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days redness or swelling is present in the painful area any new symptoms appear you have difficulty swallowing it feels like the capsule is stuck in your throat
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 right away.(1-800-222-1222).
- Do not take more than directed the smallest effective dose should be used drink a full glass of water with each dose if taken with food, this product may take longer to work adults and children 12 years and older:
- Take 1 capsule every 8 to 12 hours while symptoms last for the first dose you may take 2 capsules within the first hour do not exceed 2 capsules in any 8- to 12-hour period do not exceed 3 capsules in a 24-hour periodchildren under 12 years: ask a doctor
- Each capsule contains: sodium 20 mgstore at 20-25°C (68-77°F). Avoid high humidity and excessive heat above 40°C (104°F). read all directions and warnings before use. Keep carton.swallow whole; do not crush, chew, or dissolve
FD&C blue #1, gelatin, glycerin, lactic acid, lecithin, light mineral oil, n-butyl alcohol, polyethylene glycol, povidone, propylene glycol, purified water, shellac glaze, sorbitan, sorbitol solution, titanium dioxide, white ink
CAREONE Naproxen Sodium 220 mg
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