Aspirin

Manufacturer
GREENBRIER INTERNATIONAL, INC. | LNK International, Inc.
Effective date
2017-02-18
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-02 01:19:18

Label at a glance#

ProductAspirin
Active ingredientASPIRIN
Label structure9 sections

Indications and uses

temporarily relieves: pain and fever of colds headache muscle pain minor pain of arthritis toothache menstrual pain

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: ask a doctor

Storage and handling

use by expiration date on package store at 25º C (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)

Label contents#

Full prescribing information#

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Aspirin 325 mg (NSAID)*
*nonsteroidal anti-inflammatory drug

Purpose

OTC - PURPOSE SECTION

Pain reliever/fever reducer

Uses

INDICATIONS & USAGE SECTION

temporarily relieves:

  • pain and fever of colds
  • headache
  • muscle pain
  • minor pain of arthritis
  • toothache
  • menstrual pain

Warnings

WARNINGS SECTION

Reye's syndrome: Children and teenagers who have or 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:

  • facial swelling
  • shock
  • hives
  • asthma (wheezing)

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

  • are age 60 or older
  • 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
  • have had stomach ulcers or bleeding problems
  • take a blood thinning (anticoagulant) or steroid drug

Do not use

OTC - DO NOT USE SECTION

  • 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

OTC - ASK DOCTOR SECTION

  • you have asthma
  • 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

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

  • 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
  • an allergic reaction occurs. Seek medical help right away.
  • ringing in the ears or loss of hearing occurs
  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • any new symptoms occur

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 (1-800-222-1222) 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: ask a doctor

Other information

STORAGE AND HANDLING SECTION

  • use by expiration date on package
  • store at 25º C (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)

Inactive ingredients

INACTIVE INGREDIENT SECTION

corn starch

Questions or comments?

OTC - QUESTIONS SECTION

1-800-426-9391

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ASSURED™

Aspirin

• Aspirin 325 mg (NSAID)
Pain reliever / Fever reducer

Easy to Swallow

140tablets

50844    REV0915A24961

Distributed by: Greenbrier International, Inc.    ITEM#167219
Chesapeake, VA 23320 USA

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Assured 44-249
Assured 44-249

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130639277672193GTIN-13: 0639277672193
EAN-13: 0639277672193
GTIN-12: 639277672193
UPC-A: 639277672193
GTIN storage (14 digits): 00639277672193
assured-44-249-delisted-1.jpg

Products#

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

DailyMed product names page 1 of 1 · 2 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
33992-024933992-0249-6

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
ASPIRINR16CO5Y76EACTIB
STARCH, CORNO8232NY3SJIACT

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
013a65ae-875a-4a88-94ae-0bf225211d95ba27baa3-a7b7-40aa-a0e0-c484bef82a412017-02-18WarningsExact identifier
spl id: 013a65ae-875a-4a88-94ae-0bf225211d95
spl set id: ba27baa3-a7b7-40aa-a0e0-c484bef82a41

Reported adverse events (FAERS/openFDA)#

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