FDA.reportPublic FDA data

Pharbest Aspirin 325mg

Manufacturer
Contract Pharmacy Services-PA | Coupler Enterprises
Effective date
2017-09-22
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:52:32

Label at a glance#

ProductPharbest Aspirin 325mg
Active ingredientASPIRIN
Label structure9 sections

Indications and 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

Dosage and administration

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

Storage and handling

avoid excess heat and moisture store below 25 0 C (77 0 F)

Label contents#

Full prescribing information#

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Aspirin 325mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Purpose

OTC - PURPOSE SECTION

Pain reliever

Uses

INDICATIONS & USAGE SECTION

  • 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

WARNINGS SECTION

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

OTC - DO NOT USE SECTION

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

Ask a doctor before use if

OTC - ASK DOCTOR SECTION

  • 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

OTC - ASK DOCTOR/PHARMACIST SECTION

taking a prescription drug for

  • gout
  • diabetes
  • arthritis

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • 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

OTC - PREGNANCY OR BREAST FEEDING SECTION

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of accidental overdose, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

STORAGE AND HANDLING SECTION

  • avoid excess heat and moisture
  • store below 25 0 C (77 0 F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

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?

OTC - QUESTIONS SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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 labelimage of label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
198467aspirin 325 MG Delayed Release Oral TabletPSN1
198467aspirin 325 MG Delayed Release Oral TabletSCD1
198467ASA 325 MG Delayed Release Oral TabletSY1
198467aspirin 325 MG Enteric Coated Oral TabletSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ASPIRIN Pharmacologic Class Indexing3Indexing - Pharmacologic Class20191108

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130016103357118GTIN-13: 0016103357118
EAN-13: 0016103357118
GTIN-12: 016103357118
UPC-A: 016103357118
GTIN storage (14 digits): 00016103357118		Pharbest E.C Aspirin Regular Strength Tablet.jpg
Data codeCode 3964100010000605Pharbest E.C Aspirin Regular Strength Tablet.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d7724692-1155-4cc8-a415-22f5fc4aec35Product name620220216
bde672ba-4805-28d0-1986-73543d41b412Product name220210201
f212291f-05fe-9603-fc7e-bd73e38ce1e6Product name220161129
ade821ba-260a-47e2-bd89-743e27ac9906Product name120161121
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
9425d234-4ae1-4b53-adc6-8cc7af6dd657Product name120150929
2a21311a-89e2-0e83-2ebd-117f9798b2b2Product name120140508
9007e8a7-ff50-f9b9-7945-f2a1deadd94eProduct name120140508
96c2be53-8e44-452d-56a2-d255b2f1af2dProduct name120140508
bf8bd5f7-495f-4022-2780-7ded7ea7ea44Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67046-169-072022-01-28C16284748780-1d6a99b39-68a4-a426-e053-dadaa90af4c2169 Aspirin Enteric Coated 325 mg Drug Facts
67046-169-142022-01-28C16284748780-1d6a99b39-68a4-a426-e053-dadaa90af4c2169 Aspirin Enteric Coated 325 mg Drug Facts
67046-169-152022-01-28C16284748780-1d6a99b39-68a4-a426-e053-dadaa90af4c2169 Aspirin Enteric Coated 325 mg Drug Facts
67046-169-202022-01-28C16284748780-1d6a99b39-68a4-a426-e053-dadaa90af4c2169 Aspirin Enteric Coated 325 mg Drug Facts
67046-169-212022-01-28C16284748780-1d6a99b39-68a4-a426-e053-dadaa90af4c2169 Aspirin Enteric Coated 325 mg Drug Facts
67046-169-282022-01-28C16284748780-1d6a99b39-68a4-a426-e053-dadaa90af4c2169 Aspirin Enteric Coated 325 mg Drug Facts
67046-169-302022-01-28C16284748780-1d6a99b39-68a4-a426-e053-dadaa90af4c2169 Aspirin Enteric Coated 325 mg Drug Facts
67046-169-602022-01-28C16284748780-1d6a99b39-68a4-a426-e053-dadaa90af4c2169 Aspirin Enteric Coated 325 mg Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67046-169-07Pharbest Aspirin 325mg7 in 1 BLISTER PACKTABLET, DELAYED RELEASE71
67046-169-14Pharbest Aspirin 325mg14 in 1 BLISTER PACKTABLET, DELAYED RELEASE141
67046-169-15Pharbest Aspirin 325mg15 in 1 BLISTER PACKTABLET, DELAYED RELEASE151
67046-169-20Pharbest Aspirin 325mg20 in 1 BLISTER PACKTABLET, DELAYED RELEASE201
67046-169-21Pharbest Aspirin 325mg21 in 1 BLISTER PACKTABLET, DELAYED RELEASE211
67046-169-28Pharbest Aspirin 325mg28 in 1 BLISTER PACKTABLET, DELAYED RELEASE281
67046-169-30Pharbest Aspirin 325mg30 in 1 BLISTER PACKTABLET, DELAYED RELEASE301
67046-169-60Pharbest Aspirin 325mg60 in 1 BLISTER PACKTABLET, DELAYED RELEASE601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67046-169PHARBEST ASPIRIN 325MG (ASPIRIN) TABLET, DELAYED RELEASE [CONTRACT PHARMACY SERVICES-PA]1Legacy NDC, 8 package rows20170922_59c703f4-328a-44fa-e053-2991aa0a3e2e.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16103-357-08EA - Each16103-3577b6abbbb-4a1a-40f5-b443-15fe8f754bf512014-10-03
16103-357-11EA - Each16103-3570981b14e-f5c1-45fb-a390-cfd92a56383112014-10-03

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
67046-16967046-169-07, 67046-169-14, 67046-169-15, 67046-169-20, 67046-169-21, 67046-169-28, 67046-169-30, 67046-169-60
16103-357

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
CROSCARMELLOSE SODIUMM28OL1HH48IACT
D&C YELLOW NO. 1035SW5USQ3GIACT
D&C RED NO. 6481744AI4OIACT
HYPROMELLOSES3NXW29V3WOIACT
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)74G4R6TH13IACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
SODIUM LAURYL SULFATE368GB5141JIACT
STARCH, CORNO8232NY3SJIACT
STEARIC ACID4ELV7Z65APIACT
TALC7SEV7J4R1UIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
TRIACETINXHX3C3X673IACT
ASPIRINR16CO5Y76EACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
59c703f4-328b-44fa-e053-2991aa0a3e2e59c703f4-328a-44fa-e053-2991aa0a3e2e2017-09-22WarningsExact identifier
spl id: 59c703f4-328b-44fa-e053-2991aa0a3e2e
spl set id: 59c703f4-328a-44fa-e053-2991aa0a3e2e

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.