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Pharbest Aspirin 325mg by Pharbest Pharmaceuticals, Inc.

Medically reviewed on Oct 1, 2018

Dosage form: tablet, delayed release
Ingredients: ASPIRIN 325mg
Labeler: Pharbest Pharmaceuticals, Inc.
NDC Code: 16103-357

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.

Drug Facts

Active ingredient (in each tablet)

Aspirin 325mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever

Uses
  • temporarily relieves minor aches and pains due to • colds • headache • muscle pain • menstrual pain • minor pains of arthritis • toothache
  • or as receommended by your doctor

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
  • take a blood thinning (anticoagulant) or steroid drug
  • 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
  • have 3 or more alcoholic drinks every day while using this product

Do not use 

if you have ever had an allergic reaction to aspirin or any other pain reliever/fever reducer.

Ask a doctor before use if
  • stomach bleeding warning applies to you
  • you have a history of stomach problems, such as heartburn
  • you are taking a diuretic
  • 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 a prescription drug for

  • gout
  • diabetes
  • arthritis

Stop use and ask a doctor if
  • an allergic reaction occurs. Seek medical help right away.
  • 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
  • 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 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
  • drink a full glass of water with each dose
 adults and children 12 years and over take 1 to 2 tablets every 4 hours while symptoms persist. Do not exceed 12 tablets in 24 hours unless diretced by a physician. 
 children under 12 years consult a physician

Other information
  • avoid excess heat and moisture
  • store below 250 C (770 F)

Inactive ingredients

croscarmellose 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, triacetin. 

Questions or comments?

Adverse drug event call: 1-866-562-2756 

Manufactured in the U.S.A

PHARBEST

Aspirin Regimen 

Compare to the active ingredient in Ecotrin® Regular Strength

#1 Choise of Cardiologists

Aspirin 325mg

Regular Strength

Safety Coated Aspirin 325mg

PAIN RELIEVER (NSAID)

NOT FOR HOUSEHOLDS WITH YOUNG CHILDREN

PHARBEST ASPIRIN 325MG 
aspirin tablet, delayed release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:16103-357
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASPIRIN (ASPIRIN) ASPIRIN325 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM 
D&C YELLOW NO. 10 
D&C RED NO. 6 
HYPROMELLOSES 
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1) 
CELLULOSE, MICROCRYSTALLINE 
POLYETHYLENE GLYCOL 400 
PROPYLENE GLYCOL 
SODIUM LAURYL SULFATE 
STARCH, CORN 
STEARIC ACID 
TALC 
TITANIUM DIOXIDE 
TRIACETIN 
Product Characteristics
ColororangeScoreno score
ShapeROUNDSize10mm
FlavorImprint CodePH024
Contains    
Packaging
#Item CodePackage Description
1NDC:16103-357-081 BOTTLE in 1 CARTON
1100 TABLET, DELAYED RELEASE (TABLET) in 1 BOTTLE
2NDC:16103-357-111000 TABLET, DELAYED RELEASE in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34309/20/2010
Labeler - Pharbest Pharmaceuticals, Inc. (557054835)
Registrant - Pharbest Pharmaceuticals, Inc. (557054835)

 
Pharbest Pharmaceuticals, Inc.

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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