Label: BELMORA FLANAX- naproxen sodium tablet

  • NDC Code(s): 27854-555-01, 27854-555-02
  • Packager: Belmora LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated October 14, 2022

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

  • Drug Facts

  • Active ingredient

    Naproxen Sodium USP 220 mg

    (naproxen 200 mg) (NSAID)*

    * nonsteroidal anti-inflammatory drug

  • Purpose

    Pain reliever/fever reducer

  • 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

  • Warnings

    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

    ■ 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

    ■ have had stomach ulcers or bleeding problems

    ■ take a blood thinner (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 directed

    Heart 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

    Do not use

    ■ if you ever have 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 ■ 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

  • 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.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away.

  • 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 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 period

    Children under 12 years:

    ■ ask a doctor

  • 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 sealed packets

    ■ do not use any open or torn packets

  • Inactive ingredients

    colloidal silican dioxide, croscarmellose sodium, FD&C blue #2, macrogol, magnesium stearate, polyvinyl alcohol, povidone, pregelatinized starch, talc, titanium dioxide

  • Questions or comments?

    1-888-779-2877 M_F 9AM-5PM EST

  • PRINCIPAL DISPLAY PANEL

    labelPackBelmora LLC Flanax®

    Pain Reliever/Fever Reducer

    Longer Lasting Pain Relief

    For Temporary Relief of Minor Aches & Pains

    • Headache
    • Backache
    • Arthritis
    • Fever
    • Menstrual Cramps
    • Toothache
    • Common Cold

    20 Dual Packets

    1 Tablet Per Packet/ 40 Tablets

    220 mg Tablets Naproxen Sodium USP (NSAID)

    Belmora

  • INGREDIENTS AND APPEARANCE
    BELMORA FLANAX 
    naproxen sodium tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:27854-555
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    NAPROXEN SODIUM (UNII: 9TN87S3A3C) (NAPROXEN - UNII:57Y76R9ATQ) NAPROXEN SODIUM220 mg
    Inactive Ingredients
    Ingredient NameStrength
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    Product Characteristics
    ColorblueScoreno score
    ShapeROUNDSize10mm
    FlavorImprint Code 141
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:27854-555-0240 in 1 BOX07/20/2020
    11 in 1 PACKET; Type 0: Not a Combination Product
    2NDC:27854-555-011 in 1 CARTON09/14/2020
    224 in 1 BOTTLE; Type 0: Not a Combination Product
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09054507/20/2020
    Labeler - Belmora LLC (112753244)
    Registrant - Belmora LLC (112753244)