Aspirin

Manufacturer
Advance Pharmaceutical Inc.
Effective date
2024-12-26
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:49:24

Label at a glance#

ProductAspirin
Active ingredientASPIRIN
Label structure10 sections

Dosage and administration

this product does not contain directions or complete warnings for adult use administer only under adult supervision if possible, use weight to dose, otherwise use age repeat dose every 4 hours while symptoms last do not give more than 5 doses in 24 hours drink water with each dose Weight (lbs.) Age (years) Dose 77 – 83 11 to under 12 4 – 6 tablets 66 – 76 9 to under 11 4 - 5 tablets 46 – 65 6 to under 9 4 tablets ...

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

(in each tablet)

Aspirin 81 mg (NSAID) *

*nonsteroidal anti-inflammatory drug

Purpose

OTC - PURPOSE SECTION

Pain Reliever

Use

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 effect may occur.

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 signs of  Reye’s syndrome, a rare but serious illness.

Allergy Alert:Aspirin may cause a severe allergic reaction which may include

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

    Stomach Bleeding Warning:This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if your child

  • has had stomach ulcers or bleeding problems
  • take a blood-thinning (anticoagulant) or steroid drug
  • takes other drugs containing prescription or nonprescription NSAIDs (ibuprofen, naproxen, others)
  • takes more or for a longer time than directed

    Do not use

  • if the child has ever had an allergic reaction to any other pain reliever / fever reducer
  • for at least 7 days after tonsillectomy or oral surgery

    Ask a doctor before use if

  • stomach bleeding warning applies to your child
  • child has a history of stomach problems, such as heartburn
  • child has not been drinking fluids
  • child has lost a lot of fluid due to vomiting and diarrhea
  • child has high blood pressure, heart disease, lever cirrhosis, or kidney disease
  • child is taking a diuretic
  • child has asthma

    Ask a doctor or pharmacist before use if the child is

  • taking a prescription drug for diabetes, gout or arthritis
  • taking any other drug
  • under a doctor’s care for any serious condition

    Stop use and ask a doctor if

  • child experiences any of the following signs of stomach bleeding:
  • feels faint
  • vomits blood
  • has bloody or black stools
  • has stomach pain that does not get better
  • pain gets worse or lasts more than 5 days
  • any new symptoms appear
  • redness or swelling is present in the painful area
  • ringing in the ears or a loss of hearing occurs

    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.

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

  • this product does not contain directions or complete warnings for adult use
  • administer only under adult supervision
  • if possible, use weight to dose, otherwise use age
  • repeat dose every 4 hours while symptoms last
  • do not give more than 5 doses in 24 hours
  • drink water with each dose
    Weight (lbs.)Age (years)Dose
    77 – 8311 to under 124 – 6 tablets
    66 – 769 to under 114 - 5 tablets
    46 – 656 to under 94 tablets
    36 – 454 to under 63 tablets
    32 – 353 to under 42 tablets
    under 32under 3ask a doctor

    DRINK A FULL GLASS OF WATER WITH EACH DOSE

  • adults and children 12 years and older :take 4 to 8 tablets every 4 hours while symptoms last, but not more than 48 tablets in 24 hours.
  • Children under 12 years:ask a doctor

Other Information

SPL UNCLASSIFIED SECTION

  • store at 15-30 °C (59-86 °F)

Inactive Ingredients

INACTIVE INGREDIENT SECTION

corn starch, FD&C Yellow #6 alum. lake, magnesium stearate, orange flavor, silicon dioxide, sugar

Questions or Comments

OTC - QUESTIONS SECTION

Call 631-981-4600, 8.30am – 4.30 pm ET Monday-Friday

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

Manufactured by: Advance Pharmaceutical, Inc. Holtsville, NY 11742

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

655159bb-figure-01
655159bb-figure-01
655159bb-figure-02
655159bb-figure-02

NDC: 17714-009-36 – 36 COUNT

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
318272aspirin 81 MG Chewable TabletPSN4
318272aspirin 81 MG Chewable TabletSCD4
318272ASA 81 MG Chewable TabletSY4

DailyMed Pharmacologic Classes#

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

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17714-009-36Aspirin36 in 1 BOTTLETABLET, CHEWABLE364
17714-009-36Aspirin1 in 1 CARTONTABLET, CHEWABLE14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17714-009ASPIRIN TABLET, CHEWABLE [ADVANCE PHARMACEUTICAL INC.]4Current NDC, Legacy NDC, 2 package rows20241228_f6a9ea44-08b8-4a33-bfbd-68cb2d852c39.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ASPIRINACTIVE INGREDIENTR16CO5Y76E2
ASPIRINACTIVE MOIETYR16CO5Y76E2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A82
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I302
ORANGEINACTIVE INGREDIENT5EVU04N5QU2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU42
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJ2
SUCROSEINACTIVE INGREDIENTC151H8M5542

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
17714-00917714-009-36

Ingredients#

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

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

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 10 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
STARCH, CORNSTARCH, CORNO8232NY3SJTABLET, CHEWABLE / ORAL180 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
SUCROSESUCROSEC151H8M554TABLET, CHEWABLE / ORAL7258 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET, CHEWABLE / ORAL254 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
FD&C YELLOW NO. 6FD&C YELLOW NO. 6H77VEI93A8TABLET, CHEWABLE / ORAL0.41 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
FD&C YELLOW NO. 6FD&C YELLOW NO. 6H77VEI93A8TABLET, CHEWABLE / ORAL0.41 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
SUCROSESUCROSEC151H8M554TABLET, CHEWABLE / ORAL7258 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET, CHEWABLE / ORAL127 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET, CHEWABLE / ORAL127 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET, CHEWABLE / ORAL254 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJTABLET, CHEWABLE / ORAL180 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates

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
AspirinASPIRINAdvance Pharmaceutical Inc.f6a9ea44-08b8-4a33-bfbd-68cb2d852c392024-12-26WarningsExact identifier
ndc (package): 17714-009-36
ndc (product): 17714-009
ndc11 (package): 17714000936
spl id: 2a32783c-571f-26cb-e063-6394a90af066
spl set id: f6a9ea44-08b8-4a33-bfbd-68cb2d852c39

Reported adverse events (FAERS/openFDA)#

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