Label: FLANAX PAIN RELIEVER/FEVER REDUCER- naproxen sodium tablet, film coated

  • NDC Code(s): 27854-700-01, 27854-700-10, 27854-700-99
  • Packager: Belmora LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated May 15, 2020

If you are a consumer or patient please visit this version.

  • Drug Facts

  • Active ingredient (in each tablet)

    Naproxen sodium 220 mg (naproxen 200 mg) (NSAID)*

    *nonsteroidal anti-inflammatory drug

  • Purpose

    Pain reliever/ fever reducer

  • INDICATIONS & USAGE

    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

  • 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.

  • DOSAGE & ADMINISTRATION

    Directionsdo 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

  • 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

  • INACTIVE INGREDIENT

    Inactive ingredients colloidal silicon dioxide, FD & C Blue#2 Aluminum Lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, titanium dioxide, talc

  • Questions or comments?

    Call 1-888-779-2877 M-F 9AM-5PM EST

  • SPL UNCLASSIFIED SECTION

    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

  • Packaging

    FLX700

  • INGREDIENTS AND APPEARANCE
    FLANAX PAIN RELIEVER/FEVER REDUCER 
    naproxen sodium tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:27854-700
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    NAPROXEN SODIUM (UNII: 9TN87S3A3C) (NAPROXEN - UNII:57Y76R9ATQ) NAPROXEN220 mg
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    HYPROMELLOSE 2910 (5 MPA.S) (UNII: R75537T0T4)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL 8000 (UNII: Q662QK8M3B)  
    POVIDONE K30 (UNII: U725QWY32X)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TALC (UNII: 7SEV7J4R1U)  
    Product Characteristics
    Colorblue (light blue) Scoreno score
    ShapeROUND (Circular) Size10mm
    FlavorImprint Code J;67
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:27854-700-011 in 1 CARTON05/15/2020
    124 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:27854-700-101 in 1 CARTON05/15/2020
    210 in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:27854-700-991 in 1 CARTON05/15/2020
    3100 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20549705/15/2020
    Labeler - Belmora LLC (112753244)