aspirin

Manufacturer
Padagis US LLC
Effective date
2022-04-30
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 00:28:05

Label at a glance#

Productaspirin
Active ingredientASPIRIN
Label structure8 sections

Dosage and administration

Remove suppository from plastic packet and insert into the rectum as far as possible. Adult: One suppository every 4 hours for no more than 10 days or as directed by a physician. Children under 12 years of age: Consult a physician.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Aspirin Suppositories, USP 300 mg (5 grains)

Each suppository contains 300 mg (5 grains) of aspirin.

Indications:

OTC - PURPOSE SECTION

For the relief of minor aches, pains and headache and for reduction of fever.

Directions

DOSAGE & ADMINISTRATION SECTION

Remove suppository from plastic packet and insert into the rectum as far as possible. Adult: One suppository every 4 hours for no more than 10 days or as directed by a physician. Children under 12 years of age: Consult a physician.

Caution:

INDICATIONS & USAGE SECTION

Suppositories sealed in imprinted plastic packet. Do not use if imprinted packet is opened or damaged.

Store in a cool place 8° - 15°C (46° - 59°F) or refrigerate.

Keep this and all drugs out of the reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of accidental ingestion, seek professional assistance or contact a poison control center immediately.

Warnings

WARNINGS SECTION

CHILDREN AND TEENAGERS WHO HAVE OR ARE RECOVERING FROM CHICKEN POX, FLU SYMPTOMS, OR FLU SHOULD NOT USE THIS PRODUCT. IF NAUSEA, VOMITING, OR FEVER OCCUR, CONSULT A DOCTOR BECAUSE THESE SYMPTOMS COULD BE AN EARLY SIGN OF REYE SYNDROME, A RARE BUT SERIOUS ILLNESS.

As with any drug, if you are pregnant or nursing a baby, seek the advice of a health professional before using this product. IT IS ESPECIALLY IMPORTANT NOT TO USE ASPIRIN DURING THE LAST 3 MONTHS OF PREGNANCY UNLESS SPECIFICALLY DIRECTED TO DO SO BY A DOCTOR BECAUSE IT MAY CAUSE PROBLEMS IN THE UNBORN CHILD OR COMPLICATIONS DURING DELIVERY.

ALCOHOL WARNING:

INACTIVE INGREDIENT SECTION

If you consume 3 or more alcoholic drinks every day, ask your doctor whether you should take aspirin or other pain relievers/fever reducers. Aspirin may cause stomach bleeding.

Manufactured by Padagis

Minneapolis, MN 55427

Rev 04-22

Package/Label Principal Display Panel – 300 mg

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0574-7034-12

Aspirin Suppositories, USP

300 mg (5 grains)

For relief of pain and reduction of fever

UNIT DOSE

12 Suppositories

carton 300mg
carton 300mg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
198464aspirin 300 MG Rectal SuppositoryPSN6
198464aspirin 300 MG Rectal SuppositorySCD6
198464ASA 300 MG Rectal SuppositorySY6

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
0574-7036-122024-10-15C16284748780-11030e364-fd67-111a-e063-dadaa90a10e2Aspirin Suppositories, USP
0574-7036-122024-01-30C16284748780-11030e364-fd67-111a-e063-dadaa90a10e2Aspirin Suppositories, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0574-7034-12aspirin12 in 1 CARTONSUPPOSITORY126
0574-7034-12aspirin1 in 1 PACKETSUPPOSITORY16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0574-7034ASPIRIN SUPPOSITORY [PADAGIS US LLC]6Current NDC, Legacy NDC, 2 package rows20241023_cce244aa-cd79-49c8-b68e-267f2bd0ef67.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0574-7034-12EA - Each0574-7034be2a527b-764c-4da5-9f7f-363b796a36fe12014-10-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ASPIRINACTIVE INGREDIENTR16CO5Y76E1
ASPIRINACTIVE MOIETYR16CO5Y76E1
HYDROGENATED PALM KERNEL OILINACTIVE INGREDIENTFM8D1RE2VP1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU41

Products#

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

DailyMed product names page 1 of 1 · 3 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0574-70340574-7034-12

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Source Document#

Source XML · Source PDF

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 · 2 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4SUPPOSITORY / RECTAL14 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4SUPPOSITORY / RECTAL14 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
aspirinASPIRINPadagis US LLCcce244aa-cd79-49c8-b68e-267f2bd0ef672022-04-30WarningsExact identifier
ndc (package): 0574-7034-12
ndc (product): 0574-7034
ndc11 (package): 00574703412
spl id: a6ca751c-7438-4a0f-adae-d176f73f4915
spl set id: cce244aa-cd79-49c8-b68e-267f2bd0ef67

Reported adverse events (FAERS/openFDA)#

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