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| Product NDC Code | 27854-700 | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Drug Name | Flanax pain reliever/fever reducer |
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| Type | Brand | ||||||||
| Pharm Class | Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC] |
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| Active Ingredients |
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| Route | ORAL | ||||||||
| Dosage Form | TABLET, FILM COATED | ||||||||
| RxCUI drug identifier | 849574 | ||||||||
| Application Number | ANDA205497 | ||||||||
| Labeler Name | Belmora LLC | ||||||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient (in each tablet) Naproxen sodium 220 mg (naproxen 200 mg) (NSAID)* *nonsteroidal anti-inflammatory drug
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.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 to12 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 period ■ children under 12 years: ask a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients colloidal silicon dioxide, FD & C Blue#2 Aluminum Lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, titanium dioxide, talc
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Uses ■ temporarily relieves minor aches and pain due to: ■ headache ■ muscular aches ■ toothache ■ the common cold ■ backache ■ menstrual cramps ■ minor pain of arthritis ■ temporarily reduces fever
Purpose
Information about the drug product’s indications for use.Purpose Pain reliever/ fever reducer
Spl product data elements
Usually a list of ingredients in a drug product.Flanax Pain Reliever/Fever Reducer Naproxen sodium NAPROXEN SODIUM NAPROXEN SILICON DIOXIDE FD&C BLUE NO. 2 HYPROMELLOSE 2910 (5 MPA.S) MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL 8000 POVIDONE K30 TITANIUM DIOXIDE TALC light blue Circular J;67
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.Packaging FLX700
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Drug Facts
Longer Lasting Pain Relief 12 HOURS of pain relief KEEP OUTER PACKAGE FOR COMPLETE PRODUCT INFORMATION Distributed by Belmora LLC, 2011 Crystal Dr.#400 Arlington, VA 22202 www.flanaxusa.com Made in India TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions or comments? Call 1-888-779-2877 M-F 9AM-5PM EST
Storage and handling
Information about safe storage and handling of the drug product.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) ■ see end flap for expiration date and lot number
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.Warnings Allergy alert: Naproxen sodium may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: ■ shock ■ facial swelling ■ asthma (wheezing) ■ hives ■ skin reddening ■ blisters ■ rash 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 ■ have had stomach ulcers or bleeding problems ■ take blood thinning (anticoagulant) or steroid drug ■ 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 3 or more alcoholic drinks every day while using this product. Heart attack and stroke warning: NSAIDs, except aspirin, increases 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 are taking a diuretic ■ you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had a stroke ■ you have a 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 ■ vomit blood ■ have bloody or black stools ■ have stomach pain that does not get better ■ 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 ■ 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 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.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API