Aspirin 81mg

Manufacturer
Strive Pharmaceuticals Inc.
Effective date
2020-11-16
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:33:44

Label at a glance#

ProductAspirin 81mg
Active ingredientASPIRIN
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Aspirin 81mg (NSAID)

INACTIVE INGREDIENT SECTION

anhydrous lactose*, carnuba wax*, croscarmellose sodium, D&C yellow #10 aluminum lake, D&C yellow #6*, hydroxy propyl methyl cellulose, iron oxide*, isopropyl alcohol, magnesium stearate*, methacrylic acid copolymer type c, microcrystalline cellulose, polythylene glycol, polysorbate 80*, pregelatinized starch, silicon dioxide, sodium hydroxide*, sodium lauryl sulfate, stearic acid*, talc, titanium dioxide, triethyl citrate. *may contain.

DOSAGE & ADMINISTRATION SECTION

* drink a full glass of water with each dose SEE OVERDOSE WARNING.

adults and children 12 years of age and overtake 4 to 8 tablets every 4 hours not to exceed 48 tablets in 24 hours unless directed by a doctor
children under 12 years of ageask a doctor

INDICATIONS & USAGE SECTION

* for the temporary relief of minor aches and pains or as recommended by your doctor. Because of its delayed action, this product will not provide fast relief of headaches or other symptoms needing immediate relief.

*ask your doctor about other uses.

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 everyday while using this product
  • Take more or for a longer time than directed.

Do not use

  • 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

  • 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 taking a prescription drug for

  • Gout
  • Diabetes
  • Arthritis

Stop use and ask a doctor if

  • 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 last more than 10 days
  • Redness or swelling is present
  • Fever gets worse or last more than 3 days
  • New symptoms occur
  • Ringing in the ears or 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.

OVERDOSE WARNING: In case of overdose, get medical help or contact a Poison Control right away. Prompt medical attention is critical for adults as well as children eve if you do not notice any signs or symptoms.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

OVERDOSE WARNING: In case of overdose, get medical help or contact a Poison Control right away. Prompt medical attention is critical for adults as well as children eve if you do not notice any signs or symptoms.

OTC - PURPOSE SECTION

Pain reliever

OTHER SAFETY INFORMATION

* store at room temperature 20 - 25°C (68 - 77°F).

* avoid excessive heat, cold and humidity.

* close cap tightly after use.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CTCTLBLB

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
308416aspirin 81 MG Delayed Release Oral TabletPSN2
308416aspirin 81 MG Delayed Release Oral TabletSCD2
308416ASA 81 MG Delayed Release Oral TabletSY2
308416aspirin 81 MG Enteric Coated Oral TabletSY2

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
70692-126-012022-01-28C16284748780-1d6a99b39-985c-a426-e053-dadaa90af4c2Aspirin Low Dose Aspirin 81mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70692-126-01Aspirin 81mg100 in 1 BOTTLETABLET1002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70692-126ASPIRIN 81MG TABLET [STRIVE PHARMACEUTICALS INC.]2Legacy NDC, 1 package rows20201117_9ef52b71-55b3-5f8e-e053-2a95a90a6ece.zip

Products#

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

DailyMed product names page 1 of 1 · 24 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70692-12670692-126-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 21 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
b43e96b0-0c71-36b5-e053-2a95a90a76b39ef52b71-55b3-5f8e-e053-2a95a90a6ece2020-11-16WarningsExact identifier
spl id: b43e96b0-0c71-36b5-e053-2a95a90a76b3
spl set id: 9ef52b71-55b3-5f8e-e053-2a95a90a6ece

Reported adverse events (FAERS/openFDA)#

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