FLANAX ASPIRIN PAIN RELIEVER- aspirin tablet 
Belmora LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Flanax® Aspirin Pain Reliever

Drug Facts

Active Ingredient (in each tablet)

Aspirin 325 mg

Purposes

Pain reliever

Uses

  • For the temporary relief of minor aches and pains or as recommended by your doctor. Because of its delayed action, this product may not provide fast relief of headache or other symptoms needing immediate relief.
  • ask your doctor about other uses for this product

Warnings

Reye's syndrome

Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness.

Allergy alert

Aspirin may cause a severe allergic reaction which may include:

  • hives
  • facial swelling
  • asthma (wheezing)
  • shock

Stomach bleeding warning

This product contains a nonsteroidal anti-inflammatory drug (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 thinning (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

Do not Use

If you are allergic to aspirin or any other pain reliever/fever reducer

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, or kidney disease
  • You have asthma
  • You are taking a diuretic

Ask a doctor or pharmacist before use if you are taking a prescription drug for:

  • Gout
  • Diabetes
  • Arthritis

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
  • an allergic reaction occurs
  • fever gets worse or lasts more than 3 days
  • pain gets worse or lasts more than 10 days
  • redness or swelling is present
  • any new symptoms occur
  • ringing in the ears or loss of hearing occurs

These could be signs of a serious condition.

If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use aspirin during the last three 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.

Other Information

Temper Evident: do not use if safety seal under cap is broken or missing

  • store at room temperature
  • avoid excess heart and moisture

Directions

Drink a full glass of water with each dose

Adults and children 12 years and over:take 1 to 2 tablets every 4 hours not to exceed 12 tablets in 24 hours unless directed by a physician
Children under 12 years:consult a physician

Inactive Ingredients

Crosscarmellose Sodium, D&C Yellow# 10 Lake, FD&C Red #6, Hypromellose, Methacrylic Acid Copolymer, Microcrystalline Cellulose, Polyethylene Glycol, Propylene Glycol, Sodium Lauryl Sulfate, Starch, Stearic Acid, Talc, Titanium Dioxide.

Questions, Comments

Call 1-888-535-2629 M-F 9AM-5PM CST. Distributed by Belmora LLC P.O. Box 3063 Arlington, VA 22203

PRINCIPAL DISPLAY PANEL - 24 Tablet Bottle Carton

Belmora LLC

FLANAX®

ASPIRIN

24
325 MG TABLETS ENTERIC COATED ASPIRIN

Principal Display Panel - 24 Tablet Bottle Carton
FLANAX ASPIRIN PAIN RELIEVER 
aspirin tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:27854-105
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Aspirin (UNII: R16CO5Y76E) (Aspirin - UNII:R16CO5Y76E) Aspirin325 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
D&C RED NO. 6 (UNII: 481744AI4O)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
STARCH, CORN (UNII: O8232NY3SJ)  
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1) (UNII: 74G4R6TH13)  
Product Characteristics
ColorYELLOWScore2 pieces
ShapeROUNDSize1mm
FlavorImprint Code PH;024
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:27854-105-0224 in 1 BOTTLE; Type 0: Not a Combination Product12/06/201202/01/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34312/06/201202/01/2015
Labeler - Belmora LLC (112753244)
Establishment
NameAddressID/FEIBusiness Operations
Pharbest Pharmaceuticals, Inc.557054835MANUFACTURE(27854-105)

Revised: 11/2016
 
Belmora LLC