aspirin

Manufacturer
NCS HealthCare of KY, Inc dba Vangard Labs
Effective date
2018-08-09
Label type
HUMAN OTC DRUG LABEL
Version
11
Source
legacy-cache
Hydrated at
2026-08-01 23:42:52

Label at a glance#

Productaspirin
Active ingredientASPIRIN
Label structure15 sections

Indications and uses

temporarily relieves minor aches and pains for other uses, see your doctor, but do not use for more than 10 days without consulting your doctor because serious side effects may occur

Dosage and administration

drink a full glass of water with each dose adults and children 12 years and over:  take 4 to 8 tablets every 4 hours not to exceed 48 tablets in 24 hours unless directed by a doctor children under 12 years:  consult a doctor

Label contents#

Full prescribing information#

Active Ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Aspirin 81 mg (NSAID*)

*nonsteroidal anti-inflammatory drug

Purpose

OTC - PURPOSE SECTION

Pain reliever

Uses

INDICATIONS & USAGE SECTION

  • temporarily relieves minor aches and pains
  • for other uses, see your doctor, but do not use for more than 10 days without consulting your doctor because serious side effects may occur

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • you experience any of the following signs of stomach bleeding:

• feel faint
• have bloody or black stools

• vomit blood
• 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 in the painful area
  •  any new symptoms appear
  •  ringing in the ears or a loss of hearing occurs

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 are taking a diuretic
  • you have asthma
  • you have not been drinking fluids
  • you have lost a lot of
    fluid due to vomiting or diarrhea

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

• taking a prescription drug for diabetes, gout, or arthritis
• taking any other drug

• under a doctor’s care for any serious condition

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
  • shock
  • facial swelling
  • asthma (wheezing)

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 nonprescritpion 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 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.

Directions

DOSAGE & ADMINISTRATION SECTION

  • drink a full glass of water with each dose
  • adults and children 12 years and over:  take 4 to 8 tablets every 4 hours not to exceed 48 tablets in 24 hours unless directed by a doctor
  • children under 12 years:  consult a doctor

Other Information

OTHER SAFETY INFORMATION

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

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Inactive Ingredients

INACTIVE INGREDIENT SECTION

 BHT, dextrates, FD&C yellow #6 aluminum lake, microcrystalline cellulose, modified corn starch, orange flavor, pregelatinized starch, sodium saccharin, stearic acid

Questions or comments? (800) 616-2471

OTC - QUESTIONS SECTION

Distributed by:

MAJOR®  PHARMACEUTICALS

17177 N Laurel Park Dr.,Suite 233

Livonia, MI 48152 USA

M-14

L700313.01 Rev. 03/17

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

 Principal Display Panel - Aspirin Chewable Tabs 81mgPrincipal Display Panel - Aspirin Chewable Tabs 81mg

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-6288-80EA - Each0904-62886764713c-a888-4e9e-8a26-cee1e735d28e12017-11-06
0904-6288-89EA - Each0904-6288ed0a1686-0d72-4f58-aa21-42429910a98312012-07-24

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0615-78630615-7863-39
0904-6288

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

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
e36d556a-b5a0-4b12-bacd-8ca2c22bd96ea22b8f8d-90d4-4f3b-8f2e-eeddc7f203ad2018-08-09WarningsExact identifier
spl id: e36d556a-b5a0-4b12-bacd-8ca2c22bd96e
spl set id: a22b8f8d-90d4-4f3b-8f2e-eeddc7f203ad

Reported adverse events (FAERS/openFDA)#

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