FDA.reportPublic FDA data

MICRO-COATED ASPIRIN 325 mg

Manufacturer
NCS HealthCare of KY, Inc dba Vangard Labs
Effective date
2019-05-31
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-02 00:08:43

Label at a glance#

ProductMICRO-COATED ASPIRIN 325 mg
Active ingredientASPIRIN
Label structure9 sections

Indications and uses

temporarily relieves minor aches and pains due to: headache muscle pain toothache menstrual pain colds minor pain of arthritis temporarily reduces fever

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 or 3 tablets every 6 hours, not to exceed 12 tablets in 24 hours   children under 12 years  consult a doctor

Storage and handling

store at room temperature. Excursions permitted between 15 0 -30 0 C. Avoid excessive heat above 40 o C Tamper Evident:  do not use if safety seal under cap is broken or missing

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/ fever reducer

Uses

INDICATIONS & USAGE SECTION

  • temporarily relieves minor aches and pains due to:
  • headache
  • muscle pain
  • toothache
  • menstrual pain
  • colds
  • minor pain of arthritis
  • temporarily reduces fever

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 an 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

OTC - DO NOT USE SECTION

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

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 have high blood pressure, heart disease, liver cirrhosis or kidney disease
  • you have asthma
  • you are taking a diuretic

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

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 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 or 3 tablets every 6 hours, not to exceed 12 tablets in 24 hours 
 children under 12 years consult a doctor

Other information

STORAGE AND HANDLING SECTION

  • store at room temperature. Excursions permitted between 150-300C. Avoid excessive heat above 40oC
  • Tamper Evident: do not use if safety seal under cap is broken or missing

Inactive ingredients

INACTIVE INGREDIENT SECTION

corn starch, hypromellose, microcrystalline cellulose, stearic acid, talc, triacetin

Questions or comments?

OTC - QUESTIONS SECTION

(800) 616-2471

COMPARE TO GENUINE BAYER®ASPIRIN ACTIVE INGREDIENT**

**This product is not manufactured or distributed by Bayer, owner of the registered trademark Genuine Bayer® Aspirin.

Distributed by:

MAJOR ® PHARMACEUTICALS

17177 N Laurel Park Dr., Suite 233

Livonia, MI 48152, USA

Rev. 12/18

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Aspirin 325mg tab bingo card label
Aspirin 325mg tab bingo card label

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-6811-80EA - Each0904-6811eb7466d0-affb-4f1a-8546-4ce17ec807d112019-02-13

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0615-82800615-8280-39
0904-6811

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
ASPIRINR16CO5Y76EACTIB
STARCH, CORNO8232NY3SJIACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
STEARIC ACID4ELV7Z65APIACT
TALC7SEV7J4R1UIACT
TRIACETINXHX3C3X673IACT

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
a8b8a9ec-4a44-4df7-a2c9-0e2599c3fd3d9cfdefd2-2580-4d55-9a1f-62bb28248ee72019-05-31WarningsExact identifier
spl id: a8b8a9ec-4a44-4df7-a2c9-0e2599c3fd3d
spl set id: 9cfdefd2-2580-4d55-9a1f-62bb28248ee7

Reported adverse events (FAERS/openFDA)#

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