PHARBEST ASPIRIN 325MG- aspirin tablet, delayed release 
A-S Medication Solutions

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

Uses

  • temporarily relieves minor aches and pains due to: • minor arthritis pain • headache • toothache • menstrual pain • muscle pain • colds
  • or as recommended by a 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
  • 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 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 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 
  • redness or swelling is present 
  • new symptoms appear 
  • 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 overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Directions

  • drink a full glass of water with each dose
 adults and children 12 years and over take 1 tp 2 tablets every 4 hours not to exceed 12 tablets in 24 hours unless diretced by a doctor
 children under 12 years ask a doctor

Other information

  • store below 20-250 C (68-770 F)
  • avoid excess heat and moisture

Inactive ingredients

croscarmellose sodium, D&C yellow #10, FD&C yellow #6, hypromellose, methacrylic acid copolymer, microcrystalline cellulose, silicon dioxide, sodium bicarbonate, sodium lauryl sulfate, starch, stearic acid, talc, titanium dioxide, triacetin, triethyl citrate

Questions or comments?

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

HOW SUPPLIED

Product: 50090-0004

Aspirin

Label Image
PHARBEST ASPIRIN 325MG 
aspirin tablet, delayed release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50090-0004(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)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1) (UNII: 74G4R6TH13)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
STARCH, CORN (UNII: O8232NY3SJ)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TRIACETIN (UNII: XHX3C3X673)  
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
Product Characteristics
ColororangeScoreno score
ShapeROUNDSize10mm
FlavorImprint Code PH024
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50090-0004-3100 in 1 BOTTLE; Type 0: Not a Combination Product11/28/201412/31/2020
2NDC:50090-0004-590 in 1 BOTTLE; Type 0: Not a Combination Product11/28/201412/31/2020
3NDC:50090-0004-130 in 1 BOTTLE; Type 0: Not a Combination Product11/28/201412/31/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34309/20/201012/31/2020
Labeler - A-S Medication Solutions (830016429)
Establishment
NameAddressID/FEIBusiness Operations
A-S Medication Solutions830016429RELABEL(50090-0004) , REPACK(50090-0004)

Revised: 6/2021
Document Id: 76838ef2-d318-45be-9020-baf1d867c3cd
Set id: 557ecffd-485c-4160-aca3-4343d525bd37
Version: 14
Effective Time: 20210614
 
A-S Medication Solutions