PHARBEST ASPIRIN 325MG- aspirin tablet, delayed release 
Contract Pharmacy Services-PA

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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169 Aspirin Enteric Coated 325 mg

Drug Facts

Active ingredient (in each tablet)

Aspirin 325mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever

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 a nonsteroidal anti-inflammatory drug (NSAID), which may cause severe stomach bleeding. The chance is higher if you

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

 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

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

image of label

PHARBEST ASPIRIN 325MG 
aspirin tablet, delayed release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67046-169(NDC:16103-357)
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)  
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1) (UNII: 74G4R6TH13)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
STARCH, CORN (UNII: O8232NY3SJ)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TRIACETIN (UNII: XHX3C3X673)  
Product Characteristics
ColororangeScoreno score
ShapeROUNDSize10mm
FlavorImprint Code PH024
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67046-169-077 in 1 BLISTER PACK; Type 0: Not a Combination Product09/22/2017
2NDC:67046-169-1414 in 1 BLISTER PACK; Type 0: Not a Combination Product09/22/2017
3NDC:67046-169-1515 in 1 BLISTER PACK; Type 0: Not a Combination Product09/22/2017
4NDC:67046-169-2020 in 1 BLISTER PACK; Type 0: Not a Combination Product09/22/2017
5NDC:67046-169-2121 in 1 BLISTER PACK; Type 0: Not a Combination Product09/22/2017
6NDC:67046-169-2828 in 1 BLISTER PACK; Type 0: Not a Combination Product09/22/2017
7NDC:67046-169-3030 in 1 BLISTER PACK; Type 0: Not a Combination Product09/22/2017
8NDC:67046-169-6060 in 1 BLISTER PACK; Type 0: Not a Combination Product09/22/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34309/22/2017
Labeler - Contract Pharmacy Services-PA (945429777)
Establishment
NameAddressID/FEIBusiness Operations
Coupler Enterprises945429777repack(67046-169)

Revised: 9/2017
Document Id: 59c703f4-328b-44fa-e053-2991aa0a3e2e
Set id: 59c703f4-328a-44fa-e053-2991aa0a3e2e
Version: 1
Effective Time: 20170922
 
Contract Pharmacy Services-PA