Aspirin

Manufacturer
Rebel Distributors Corp
Effective date
2011-02-17
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:27:17

Label at a glance#

ProductAspirin
Active ingredientASPIRIN
Label structure9 sections

Indications and uses

For the temporary relief of minor aches and pains. Ask your doctor about other uses for aspirin.

Dosage and administration

Drink a full glass of water with each dose. Swallow whole; do not chew or crush. Do not exceed recommend dose. Adults and children 12 years and older: take 1-2 tablets every 4 hours, as needed, not more than 12 tablets in 24 hours, or as directed by a doctor. Children under 12: ask a doctor.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Aspirin 325mg

Purpose

OTC - PURPOSE SECTION

Pain Reliever

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.

Uses

INDICATIONS & USAGE SECTION

For the temporary relief of minor aches and pains. Ask your doctor about other uses for aspirin.

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 or 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) or 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 if you are allergic to aspirin or any other pain reliever/fever reducer.

Ask a doctor before use if ° the stomach bleeding warning applies to you ° you are taking a diuretic ° you have a history of stomach problems such as heartburn ° you have high blood pressure, heart disease, liver cirrhosis, kidney disease or asthma.

Ask a doctor or pharmacist before use if you are ° taking any other drug containing an NSAID (prescription or nonprescription) ° taking a blood thinning (anticoagulant) or steroid drug ° taking a prescription drug for diabetes, gout or arthritis.

Stop use and ask a doctor if ° 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, an allergic reaction occurs. Seek medical help right away if pain gets worse or lasts more than 10 days, redness or swelling is present, fever gets worse or lasts more than 3 days, any new symptoms occur, or 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.

Directions

DOSAGE & ADMINISTRATION SECTION

Drink a full glass of water with each dose. Swallow whole; do not chew or crush. Do not exceed recommend dose.

Adults and children 12 years and older: take 1-2 tablets every 4 hours, as needed, not more than 12 tablets in 24 hours, or as directed by a doctor.

Children under 12: ask a doctor.

Other Information

SPL UNCLASSIFIED SECTION

Store at room temperature, 15°C - 30°C (59°F - 86°F).

For institutional use only.

Inactive ingredients

INACTIVE INGREDIENT SECTION

May contain acetylated monoglycerides, cellulose, croscarmellose sodium, D&C yellow no. 10, FD&C yellow no. 6, hypromellose, hypromellose phthalate, iron oxide, methacrylic acid, mineral oil, PEG, polydextrose, polysorbate 80, polyvinyl acetate phthalate, propylene glycol, silica sodium alginate, sodium bicarbonate, sodium lauryl sulfate, starch stearic acid, talc, titanium dioxide, triacetin, triethyl citrate, wax.

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Aspirin EC 325mgAspirin EC 325mg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
198467aspirin 325 MG Delayed Release Oral TabletPSN1
198467aspirin 325 MG Delayed Release Oral TabletSCD1
198467ASA 325 MG Delayed Release Oral TabletSY1
198467aspirin 325 MG Enteric Coated Oral TabletSY1

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
d7724692-1155-4cc8-a415-22f5fc4aec35Product name620220216
bde672ba-4805-28d0-1986-73543d41b412Product name220210201
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
f212291f-05fe-9603-fc7e-bd73e38ce1e6Product name220161129
ade821ba-260a-47e2-bd89-743e27ac9906Product name120161121
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
9425d234-4ae1-4b53-adc6-8cc7af6dd657Product name120150929
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
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
21695-666-002019-09-24C16284748780-1934fe258-49d1-48b1-e053-8cdaa90a720aAspirin Drug Facts
21695-666-302019-09-24C16284748780-1934fe258-49d1-48b1-e053-8cdaa90a720aAspirin Drug Facts
21695-666-902019-09-24C16284748780-1934fe258-49d1-48b1-e053-8cdaa90a720aAspirin Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-666-00Aspirin100 in 1 BOTTLETABLET1001
21695-666-30Aspirin30 in 1 BOTTLETABLET301
21695-666-90Aspirin90 in 1 BOTTLETABLET901

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-666ASPIRIN TABLET [REBEL DISTRIBUTORS CORP]1Legacy NDC, 3 package rows20110223_3599c90e-4cb0-475e-9d1e-8172c8ce014c.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-666-00EA - Each21695-66696fee348-77d3-43ab-9cc7-f26cdac12d8e12012-07-24
21695-666-30EA - Each21695-666f32ab2f5-a6ce-4f90-92c3-3d34674473ce12012-07-24
21695-666-90EA - Each21695-666256d1eb2-aa7b-4a3b-8cc7-0960666b321012012-07-24
57896-401-01EA - Each57896-401da8e6844-b6ae-4244-8bfc-f7ad99d8eaf812013-06-04
57896-401-03EA - Each57896-4016762957d-d7f6-4213-a664-2c7f42fc9f3612013-06-04
57896-401-10EA - Each57896-4017ae1d03c-6162-4398-b8d2-1946db28e94112013-06-04
57896-401-20EA - Each57896-4018f701acd-94d7-43d2-9072-f8fbf72510af12021-02-05
57896-401-25EA - Each57896-4015c82cab7-f225-43ff-b3f5-38f5ffd4b01a12018-11-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ASPIRINACTIVE INGREDIENTR16CO5Y76E1
ASPIRINACTIVE MOIETYR16CO5Y76E1
CELLULOSE ACETATEINACTIVE INGREDIENT3J2P07GVB61
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH481
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3G1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A81
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G6751
HYPROMELLOSE PHTHALATE (24% PHTHALATE, 55 CST)INACTIVE INGREDIENT87Y6436BKR1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WO1
METHACRYLIC ACIDINACTIVE INGREDIENT1CS02G86561
MINERAL OILINACTIVE INGREDIENTT5L8T28FGP1
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IE1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8H1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V31
SODIUM ALGINATEINACTIVE INGREDIENTC269C4G2ZQ1
SODIUM BICARBONATEINACTIVE INGREDIENT8MDF5V39QO1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141J1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65AP1
TALCINACTIVE INGREDIENT7SEV7J4R1U1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JP1
TRIACETININACTIVE INGREDIENTXHX3C3X6731
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UM1
WHITE WAXINACTIVE INGREDIENT7G1J5DA97F1

Products#

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

DailyMed product names page 1 of 1 · 22 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
21695-66621695-666-30, 21695-666-90, 21695-666-00
57896-401

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 22 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 4 · 224 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
SODIUM BICARBONATESODIUM BICARBONATE8MDF5V39QOTABLET, ORALLY DISINTEGRATING / ORAL107 mgExact identifier — unii+route
17 equally ranked IID candidates
CROSCARMELLOSE SODIUMCROSCARMELLOSE SODIUMM28OL1HH48TABLET, DELAYED RELEASE PARTICLES / ORAL64 mgExact identifier — unii+route
20 equally ranked IID candidates
TALCTALC7SEV7J4R1UELIXIR / ORAL4.5 mg/5mlExact identifier — unii+route
29 equally ranked IID candidates
TALCTALC7SEV7J4R1UCAPSULE / ORAL729 mgExact identifier — unii+route
29 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JPELLET / ORAL2 mgExact identifier — unii+route
23 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APTABLET, FILM COATED, EXTENDED RELEASE / ORAL120 mgExact identifier — unii+route
12 equally ranked IID candidates
SODIUM BICARBONATESODIUM BICARBONATE8MDF5V39QOTABLET, EFFERVESCENT / ORAL57600 mgExact identifier — unii+route
17 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOGRANULE / ORAL45 mgExact identifier — unii+route
17 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3CAPSULE, COATED / ORAL25 mgExact identifier — unii+route
20 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPCAPSULE / ORAL120 mgExact identifier — unii+route
9 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JTABLET, FOR SUSPENSION / ORAL264 mgExact identifier — unii+route
23 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOCAPSULE, EXTENDED RELEASE / ORAL119.7 mgExact identifier — unii+route
17 equally ranked IID candidates
TALCTALC7SEV7J4R1UTABLET, DELAYED RELEASE PARTICLES / ORAL56 mgExact identifier — unii+route
29 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOGRANULE, FOR SUSPENSION / ORAL1.7 mgExact identifier — unii+route
17 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JTABLET, COATED / ORAL123 mgExact identifier — unii+route
23 equally ranked IID candidates
WHITE WAXWHITE WAX7G1J5DA97FCAPSULE, EXTENDED RELEASE / ORAL71 mgExact identifier — unii+route
7 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SUSPENSION / ORAL27120 mgExact identifier — unii+route
20 equally ranked IID candidates
TALCTALC7SEV7J4R1UTABLET, EXTENDED RELEASE / ORAL300 mgExact identifier — unii+route
29 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JTABLET, CHEWABLE / ORAL6 mgExact identifier — unii+route
23 equally ranked IID candidates
TRIETHYL CITRATETRIETHYL CITRATE8Z96QXD6UMCAPSULE, DELAYED RELEASE / ORAL70 mgExact identifier — unii+route
18 equally ranked IID candidates
TRIETHYL CITRATETRIETHYL CITRATE8Z96QXD6UMTABLET, ORALLY DISINTEGRATING / ORAL17 mgExact identifier — unii+route
18 equally ranked IID candidates
TALCTALC7SEV7J4R1UGRANULE, FOR SUSPENSION / ORAL296 mgExact identifier — unii+route
29 equally ranked IID candidates
FD&C YELLOW NO. 6FD&C YELLOW NO. 6H77VEI93A8CAPSULE, LIQUID FILLED / ORAL1 mgExact identifier — unii+route+dosage form
SODIUM ALGINATESODIUM ALGINATEC269C4G2ZQLOZENGE / ORAL1274 mgExact identifier — unii+route
7 equally ranked IID candidates
CROSCARMELLOSE SODIUMCROSCARMELLOSE SODIUMM28OL1HH48PELLET / ORAL162 mgExact identifier — unii+route
20 equally ranked IID candidates
WHITE WAXWHITE WAX7G1J5DA97FCAPSULE / ORAL79 mgExact identifier — unii+route
7 equally ranked IID candidates
TRIACETINTRIACETINXHX3C3X673SUSPENSION / ORAL7 mgExact identifier — unii+route
13 equally ranked IID candidates
HYPROMELLOSE PHTHALATE (24% PHTHALATE, 55 CST)HYPROMELLOSE PHTHALATE (24% PHTHALATE, 55 CST)87Y6436BKRCAPSULE, EXTENDED RELEASE / ORAL103 mgExact identifier — unii+route
5 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JGRANULE / ORAL12 mgExact identifier — unii+route
23 equally ranked IID candidates
SODIUM BICARBONATESODIUM BICARBONATE8MDF5V39QOGUM, CHEWING / ORAL360 mgExact identifier — unii+route
17 equally ranked IID candidates
TRIACETINTRIACETINXHX3C3X673POWDER, FOR SUSPENSION / ORAL12 mgExact identifier — unii+route
13 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JSUSPENSION, EXTENDED RELEASE / ORAL0.08 mg/1mlExact identifier — unii+route
23 equally ranked IID candidates
CROSCARMELLOSE SODIUMCROSCARMELLOSE SODIUMM28OL1HH48TABLET, CHEWABLE / ORAL216 mgExact identifier — unii+route
20 equally ranked IID candidates
SODIUM BICARBONATESODIUM BICARBONATE8MDF5V39QOTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL6 mgExact identifier — unii+route
17 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APEMULSION / ORALNAExact identifier — unii+route
12 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APCAPSULE / ORAL90 mgExact identifier — unii+route
12 equally ranked IID candidates
CROSCARMELLOSE SODIUMCROSCARMELLOSE SODIUMM28OL1HH48CAPSULE, EXTENDED RELEASE / ORAL53 mgExact identifier — unii+route
20 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3CAPSULE / ORAL1072 mgExact identifier — unii+route
20 equally ranked IID candidates
HYPROMELLOSE PHTHALATE (24% PHTHALATE, 55 CST)HYPROMELLOSE PHTHALATE (24% PHTHALATE, 55 CST)87Y6436BKRCAPSULE / ORAL585 mgExact identifier — unii+route
5 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOTABLET, FILM COATED / ORAL582 mgExact identifier — unii+route
17 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOTABLET, FILM COATED, EXTENDED RELEASE / ORAL221 mgExact identifier — unii+route
17 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JCAPSULE, COATED, EXTENDED RELEASE / ORALNAExact identifier — unii+route
23 equally ranked IID candidates
TALCTALC7SEV7J4R1UGRANULE / ORAL322 mgExact identifier — unii+route
29 equally ranked IID candidates
FERRIC OXIDE REDFERRIC OXIDE RED1K09F3G675TABLET, DELAYED RELEASE / ORAL37 mgExact identifier — unii+route
17 equally ranked IID candidates
CROSCARMELLOSE SODIUMCROSCARMELLOSE SODIUMM28OL1HH48POWDER, FOR SUSPENSION / ORAL11.25 mgExact identifier — unii+route
20 equally ranked IID candidates
CROSCARMELLOSE SODIUMCROSCARMELLOSE SODIUMM28OL1HH48TABLET, ORALLY DISINTEGRATING / ORAL184 mgExact identifier — unii+route
20 equally ranked IID candidates
FERRIC OXIDE REDFERRIC OXIDE RED1K09F3G675SUSPENSION, EXTENDED RELEASE / ORAL2.7 mgExact identifier — unii+route
17 equally ranked IID candidates
CROSCARMELLOSE SODIUMCROSCARMELLOSE SODIUMM28OL1HH48TABLET, DELAYED RELEASE / ORAL280 mgExact identifier — unii+route
20 equally ranked IID candidates
SODIUM BICARBONATESODIUM BICARBONATE8MDF5V39QOLOZENGE / ORAL100 mgExact identifier — unii+route
17 equally ranked IID candidates
TRIETHYL CITRATETRIETHYL CITRATE8Z96QXD6UMCAPSULE, COATED / ORAL7 mgExact identifier — unii+route
18 equally ranked IID candidates
TRIETHYL CITRATETRIETHYL CITRATE8Z96QXD6UMTABLET, EXTENDED RELEASE / ORAL160 mgExact identifier — unii+route
18 equally ranked IID candidates
CROSCARMELLOSE SODIUMCROSCARMELLOSE SODIUMM28OL1HH48SUSPENSION / ORAL150 mgExact identifier — unii+route
20 equally ranked IID candidates
TRIETHYL CITRATETRIETHYL CITRATE8Z96QXD6UMTABLET / ORAL52 mgExact identifier — unii+route
18 equally ranked IID candidates
SODIUM BICARBONATESODIUM BICARBONATE8MDF5V39QOTABLET / ORAL1300 mgExact identifier — unii+route
17 equally ranked IID candidates
FERRIC OXIDE REDFERRIC OXIDE RED1K09F3G675TABLET, FILM COATED, EXTENDED RELEASE / ORAL3.6 mgExact identifier — unii+route
17 equally ranked IID candidates
D&C YELLOW NO. 10D&C YELLOW NO. 1035SW5USQ3GCAPSULE, LIQUID FILLED / ORAL1.51 mgExact identifier — unii+route+dosage form
SODIUM BICARBONATESODIUM BICARBONATE8MDF5V39QOSOLUTION / ORALADJ PHExact identifier — unii+route
17 equally ranked IID candidates
TRIETHYL CITRATETRIETHYL CITRATE8Z96QXD6UMTABLET, DELAYED RELEASE / ORAL120 mgExact identifier — unii+route
18 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOTABLET / ORAL1127 mgExact identifier — unii+route
17 equally ranked IID candidates
TRIETHYL CITRATETRIETHYL CITRATE8Z96QXD6UMCAPSULE, COATED, EXTENDED RELEASE / ORAL7 mgExact identifier — unii+route
18 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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Stool SoftenerDOCUSATE SODIUMGeri-Care Pharmaceutical Corp644d81ec-d38f-4172-a087-727b94e2fefe2023-10-19WarningsExact identifier
ndc (product): 57896-401
3599c90e-4cb0-475e-9d1e-8172c8ce014c3599c90e-4cb0-475e-9d1e-8172c8ce014c2011-02-17WarningsExact identifier
spl id: 3599c90e-4cb0-475e-9d1e-8172c8ce014c
spl set id: 3599c90e-4cb0-475e-9d1e-8172c8ce014c

Reported adverse events (FAERS/openFDA)#

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