FDA.reportPublic FDA data

Ascurin (Aspirin Capsules 81mg)

Manufacturer
Healthdoc LLC
Effective date
2023-11-13
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:03:48

Label at a glance#

ProductAscurin
Active ingredientASPIRIN
Label structure8 sections

Dosage and administration

Adults: Drink a full glass of water with each dose. Adults and children 12 years and over: Take 5-8 capsules every 4 hours not to exceed 49 capsules in 24 hours unless directed by a doctor. Children under 12 years of age: consult a doctor. See your doctor for other uses of aspirin, but do not use for more than 10 days without consulting your doctor because serious side effects may occur.

Label contents#

Full prescribing information#

Active ingredient (per capsule)

OTC - ACTIVE INGREDIENT SECTION

Aspirin (NSAID*) 81mg

Purpose

OTC - PURPOSE SECTION

pain reliever-fever reducer *nonsteriodal anti-inflammatory drug

Use

INDICATIONS & USAGE SECTION

For the temporary relief of minor aches and pains associated with a cold, headache, toothache, muscular aches, backache, the premenstrual and menstrual periods, for the minor pain from arthritis and to reduce 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 have ever had an allergic reaction to 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 have high blood pressure, heart disease, liver cirrhosis, or kidney disease
  • you are taking a diuretic
  • you have asthma

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

  • taking a prescription drug for diabetes, gout, or 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
  • any new symptoms occur
  • ringing in the ears or loss of hearing occurs

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

  • Adults: Drink a full glass of water with each dose.
  • Adults and children 12 years and over: Take 5-8 capsules every 4 hours not to exceed 49 capsules in 24 hours unless directed by a doctor.
  • Children under 12 years of age: consult a doctor.
  • See your doctor for other uses of aspirin, but do not use for more than 10 days without consulting your doctor because serious side effects may occur.

Other information

SPL UNCLASSIFIED SECTION

Do not use the product if the bottle seal inside the bottle lid is broken.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Curcumin, Hydroxypropyl Methylcellulose, Orange Oil, Polyvinylpyrrolidone.

Questions or Comments?

OTC - QUESTIONS SECTION

Call (609) 902-7128 9:00 AM – 7:00 PM E.T. Monday-Friday

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Outer Package0Outer Package0Inner Package0Inner Package0

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
252857aspirin 81 MG Oral CapsulePSN1
252857aspirin 81 MG Oral CapsuleSCD1
252857ASA 81 MG Oral CapsuleSY1

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
83607-002-002025-01-30C16284748780-12cef2736-75b7-d83d-e063-dadaa90ab31fAscurin (Aspirin Capsules 81mg)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83607-002-00Ascurin1 in 1 BOXCAPSULE11
83607-002-00Ascurin30 in 1 BOTTLECAPSULE301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83607-002ASCURIN (ASPIRIN) CAPSULE [HEALTHDOC LLC]12 package rows20231210_d5fd2852-47cd-4a88-a421-69f29c57df9e.zip

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83607-00283607-002-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
CURCUMINIT942ZTH98IACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
ORANGE OIL, COLD PRESSEDAKN3KSD11BIACT
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
0a0aae7a-7db5-3f96-e063-6294a90a6f81d5fd2852-47cd-4a88-a421-69f29c57df9e2023-11-13WarningsExact identifier
spl id: 0a0aae7a-7db5-3f96-e063-6294a90a6f81
spl set id: d5fd2852-47cd-4a88-a421-69f29c57df9e

Reported adverse events (FAERS/openFDA)#

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