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Flanax by Belmora LLC

Medically reviewed on December 18, 2017

Dosage form: tablet, coated
Ingredients: NAPROXEN SODIUM 220mg
Labeler: Belmora LLC
NDC Code: 27854-160

Flanax 44-417

Active ingredient (in each tablet)

Naproxen sodium 220 mg (naproxen 200 mg) (NSAID)*
*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever/fever reducer

Uses
  • temporarily relieves minor aches and pains due to:
    • toothache
    • muscular aches
    • backache
    • the common cold
    • headache
    • 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:

  • 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

Do not use
  • right before or after heart surgery
  • if you have ever had an allergic reaction to any other pain reliever/fever reducer

Ask a doctor before use if you have
  • the stomach bleeding warning applies to you
  • you are taking a diuretic
  • you have a history of stomach problems, such as heartburn
  • you have problems or serious side effects from taking pain relievers or fever reducers
  • you have asthma
  • you have high blood pressure, heart disease, liver cirrhosis, or kidney disease

Ask a doctor or pharmacist before use if you are
  • taking any other drug
  • under a doctor’s care for any serious condition

When using this product
  • take with food or milk if stomach upset occurs
  • the risk of heart attack or stroke may increase if you use more than directed or for longer than directed

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
  • 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
  • redness or swelling is present in the painful area
  • it feels like the pill 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 (1-800-222-1222) 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 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 ingredients

croscarmellose sodium, FD&C blue #2 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, talc, titanium dioxide

Questions or comments?

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

Principal display panel

NDC 27854-160-01

Belmora LLC

FLANAX®

Naproxen Sodium Tablets, 220 mg
Pain Reliever/Fever Reducer
(NSAID)

10 TABLETS

Actual Size

FLANAX®

Longer Lasting
Pain Relief

FOR TEMPORARY RELIEF OF MINOR
ACHES & PAINS:

• HEADACHE • BACKACHE
• ARTHRITIS • FEVER
• MENSTRUAL CRAMPS
• TOOTHACHE
• COMMON COLD

TAMPER EVIDENT: DO NOT USE IF IMPRINTED
SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Distributed by Belmora LLC, 2231 Crystal Dr. #1000
Arlington, VA 22202 www.flanaxusa.com

Flanax 44-417

FLANAX 
naproxen sodium tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:27854-160
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NAPROXEN SODIUM (NAPROXEN) NAPROXEN SODIUM220 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM 
FD&C BLUE NO. 2 
MAGNESIUM STEARATE 
MICROCRYSTALLINE CELLULOSE 
POLYETHYLENE GLYCOL, UNSPECIFIED 
POLYVINYL ALCOHOL, UNSPECIFIED 
POVIDONE, UNSPECIFIED 
SILICON DIOXIDE 
TALC 
TITANIUM DIOXIDE 
Product Characteristics
ColorBLUEScoreno score
ShapeROUNDSize10mm
FlavorImprint Code44;417
Contains    
Packaging
#Item CodePackage Description
1NDC:27854-160-011 BOTTLE, PLASTIC in 1 CARTON
110 TABLET, COATED in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20487201/15/2018
Labeler - Belmora LLC (112753244)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867894MANUFACTURE(27854-160)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867837PACK(27854-160)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.967626305PACK(27854-160)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.038154464PACK(27854-160)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.868734088PACK(27854-160)

 
Belmora LLC

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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