FDA.reportPublic FDA data

Aspirin 81mg - Gendose Pharmaceuticals, LLC | Allegiant Health

Manufacturer
Gendose Pharmaceuticals, LLC | Allegiant Health
Effective date
2026-10-06
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
daily-update
Hydrated at
2026-10-13 04:04:16

Label at a glance#

ProductAspirin 81mg
Active ingredientASPIRIN
Label structure9 sections

Indications and uses

for temporary relief of minor aches and pains or as recommended by your doctor. ask your doctor for other uses of this product.

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

Storage and handling

• store at 25 ° C (77 ° F); excursions permitted between 15°-30°C (59° - 86°F)

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

  • for temporary relief of minor aches and pains or as recommended by your doctor.
  • ask your doctor for other uses of this product.

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 are allergic to aspirin or any other pain reliever/fever reducer. 
  • this product for at least 7 days after tonsillectomy or oral surgery unless directed by a doctor.
  • 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

  • the 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

•gout •diabetes •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

• new symptoms occur

• ringing in the ears or a 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 at 20 weeks or later in 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 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

STORAGE AND HANDLING SECTION

• store at 25 °C (77 °F); excursions permitted between 15°-30°C (59° - 86°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

dextrates, FD&C yellow #6 aluminum lake, orange flavor, saccharin sodium, corn starch

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-888-676-7161

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display Panel

11

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeDataBar Omni(01)00377333049205GTIN-14: 00377333049205
GTIN-12: 377333049205
UPC-A: 377333049205
EAN-13: 0377333049205
GTIN storage (14 digits): 00377333049205		label.jpg

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
77333-049-20EA - Each77333-049751aa422-3704-41c4-aa43-9d66792bddaa12025-05-14
77333-049-25EA - Each77333-04928b1ccbc-19d3-41e3-8190-fcc8578b4ede12025-05-14

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
77333-04977333-049-25, 77333-049-20

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
ASPIRINR16CO5Y76EACTIB
DEXTRATESG263MI44RUIACT
FD&C YELLOW NO. 6 ALUMINUM LAKEGYP6Z2JR6QIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
STARCH, CORNO8232NY3SJIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
12025-04-11full-release2026-06-01 01:00:00

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
327e1152-7e30-6741-e063-6394a90ad8121d6552e8-4f89-411f-a352-8f7835851fc02025-04-11WarningsExact identifier
spl set id: 1d6552e8-4f89-411f-a352-8f7835851fc0

Reported adverse events (FAERS/openFDA)#

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