BELMORA FLANAX- naproxen sodium tablet, film coated 
Unifirst First Aid Corporation

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Belmora Flanax Private Label Distributor

Drug Facts

Active ingredient

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

Purpose

Pain reliever/fever reducer

Uses

Temporary relieves minor aches and pains due to:

Temporarily reduces fever

Wanings

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 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

Ask a doctor before use if

Ask a doctor or pharmacist before use if you are

When using this product

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

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 accidental overdose, get medical help or contact a Poison Control Center right away.

Directions

Adults: (12 years of age and older)

Children under 12 years:

ask a doctor

Other information

Inactive ingredients

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

Belmora LLC, 2231 Crystal Dr. Suite 1000, Arlington, VA 22202

Source NDC 47682-237
PLD Belmora Flanax Label

Flanax®

Pain Reliever/Fever Reducer

Longer Lasting Pain Relief

For Temporary Relief Of Minor Aches & Pains

20 Dual Packets

1 Tablet Per Packet

40 Tablets

220MG Tablets Naproxen Sodium USP (NSAID)

237R

BELMORA FLANAX 
naproxen sodium tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:47682-037
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
POVIDONE (UNII: FZ989GH94E)  
STARCH, CORN (UNII: O8232NY3SJ)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
TALC (UNII: 7SEV7J4R1U)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
Product Characteristics
ColorblueScoreno score
ShapeROUNDSize9mm
FlavorImprint Code I;3
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:47682-037-5050 in 1 BOX12/30/2008
11 in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07909612/30/2008
Labeler - Unifirst First Aid Corporation (832947092)
Registrant - Prestige Packaging (170837962)
Establishment
NameAddressID/FEIBusiness Operations
Prestige Packaging080667761pack(47682-037)
Establishment
NameAddressID/FEIBusiness Operations
Amneal Pharmaceuticals of New York, LLC831227801manufacture(47682-037)

Revised: 1/2023
Document Id: ebf3deb7-0831-d81b-e053-2a95a90ae3be
Set id: 8591ca57-04ee-5053-e053-2991aa0aa4dd
Version: 4
Effective Time: 20230110
 
Unifirst First Aid Corporation