Drug Facts
Composition & Profile
Identifiers & Packaging
Principal display panel NDC 27854-165-10 Belmora LLC FLANAX ® MENSTRUAL PAIN RELIEVER Naproxen Sodium Tablets, 220 mg (NSAID) PAIN RELIEVER/ FEVER REDUCER Actual Size 10 | CAPLETS UP TO 12 HOURS of menstrual pain relief TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING Distributed by: Belmora LLC 3101 Wilson Blvd. Suite 500 Arlington, VA 22201 www.flanaxusa.com WWW.FLANAX.COM REV1221C60403 Belmora 44-604 Belmora 44-604
- Principal display panel NDC 27854-165-10 Belmora LLC FLANAX ® MENSTRUAL PAIN RELIEVER Naproxen Sodium Tablets, 220 mg (NSAID) PAIN RELIEVER/ FEVER REDUCER Actual Size 10 | CAPLETS UP TO 12 HOURS of menstrual pain relief TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING Distributed by: Belmora LLC 3101 Wilson Blvd. Suite 500 Arlington, VA 22201 www.flanaxusa.com WWW.FLANAX.COM REV1221C60403 Belmora 44-604 Belmora 44-604
Overview
Uses temporarily relieves minor aches and pains due to: menstrual cramps headache the common cold toothache muscular aches backache minor pain of arthritis temporarily reduces fever
Indications & Usage
Uses temporarily relieves minor aches and pains due to: menstrual cramps headache the common cold toothache muscular aches backache minor pain of arthritis temporarily reduces fever
Dosage & Administration
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 caplet every 8 to 12 hours while symptoms last for the first dose you may take 2 caplets within the first hour do not exceed 2 caplets in any 8- to 12-hour period do not exceed 3 caplets in a 24-hour period children under 12 years: ask a doctor
Warnings & Precautions
Warnings Allergy alert: Naproxen sodium may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: asthma (wheezing) shock facial swelling rash hives skin reddening 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 take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others] take more or for a longer time than directed 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 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. 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 you are taking a diuretic the stomach bleeding warning applies to you you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had a stroke you have a history of stomach problems, such as heartburn you have problems or serious side effects from taking pain relievers or fever reducers Ask a doctor or pharmacist before use if you are taking aspirin for heart attack or stroke, because naproxen may decrease this benefit of aspirin 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: have bloody or black stools have stomach pain that does not get better feel faint vomit blood you have symptoms of heart problems or stroke: leg swelling chest pain slurred speech trouble breathing weakness in one part or side of body pain gets worse or lasts more than 10 days you have difficulty swallowing fever gets worse or lasts more than 3 days any new symptoms appear it feels like the pill is stuck in your throat redness or swelling is present in the painful area If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use naproxen sodium at 20 weeks or later in 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.
Purpose
Purpose Pain reliever/fever reducer
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
When Using
When using this product take with food or milk if stomach upset occurs
Stop Use & Ask a Doctor
Stop use and ask a doctor if you experience any of the following signs of stomach bleeding: have bloody or black stools have stomach pain that does not get better feel faint vomit blood you have symptoms of heart problems or stroke: leg swelling chest pain slurred speech trouble breathing weakness in one part or side of body pain gets worse or lasts more than 10 days you have difficulty swallowing fever gets worse or lasts more than 3 days any new symptoms appear it feels like the pill is stuck in your throat redness or swelling is present in the painful area
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.
Storage & Handling
Other information each caplet contains: sodium 20 mg store at 20°-25°C (68°-77°F). Avoid high humidity and excessive heat above 40°C (104°F) see end flap for expiration date and lot number
Questions
Questions or comments? Call 1-888-779-2877 M-F 9 AM-5 PM ET
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