PHARBEST REGULAR STRENGTH ASPIRIN- aspirin tablet 
Pharbest Pharmaceuticals, Inc

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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Drug Facts

Active ingredient (in each tablet)

Aspirin 325mg (NSAID)

nonsteroidal anti-inflammatory drug

Purpose

Pain reliever/fever reducer

Uses

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

Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you

Do not use

  • if you are allergic to aspirin or any other pain reliever/fever reducer
  • if you have ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if

  • 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 are taking a diuretic
  • you have asthma

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

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 overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Directions

adults and children 12 years and over take 1 or 2 tablets every 4 hours or 3 tablets every 6 hours, not to exceed 12 tablets in 24 hours
 children under 12 years ask a doctor

Other information

Inactive ingredient

corn starch

Questions or comments?

(866)562-2756 (Mon-Fri 8 AM to 4 PM EST)

PHARBEST

NDC 16103-365-11

Manufactured in the USA

*Compare to the active ingredient in Genuine Bayer® Aspirin

Aspirin

Regular Strength

Pain Reliever/Fever Reducer (NSAID)

1000 TABLETS

Aspirin, 325 mg each

Regular strength Aspirin 325mg tablet Product Label

PHARBEST REGULAR STRENGTH ASPIRIN 
aspirin tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:16103-365
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN325 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN (UNII: O8232NY3SJ)  
Product Characteristics
ColorwhiteScoreno score
ShapeROUND (ROUND TABLET) Size10mm
FlavorImprint Code PH033
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:16103-365-081 in 1 CARTON01/12/2007
1100 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:16103-365-111000 in 1 BOTTLE; Type 0: Not a Combination Product01/12/2007
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34301/12/2007
Labeler - Pharbest Pharmaceuticals, Inc (557054835)
Registrant - Pharbest Pharmaceuticals, Inc (557054835)
Establishment
NameAddressID/FEIBusiness Operations
Pharbest Pharmaceuticals, Inc557054835analysis(16103-365) , manufacture(16103-365) , label(16103-365) , pack(16103-365)

Revised: 1/2021
Document Id: 1b710869-90ca-4656-a0f3-ee524dea884f
Set id: 6403dd67-4e37-4928-8505-2be590247408
Version: 2
Effective Time: 20210111
 
Pharbest Pharmaceuticals, Inc