Aspirin 325 mg tablets

Manufacturer
TIME CAP LABS INC
Effective date
2023-11-22
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:02:42

Label at a glance#

ProductASPIRIN
Active ingredientASPIRIN
Label structure14 sections

Indications and uses

Uses for the temporary relief of minor aches and pains due to headache colds menstrual pain muscle pain toothache minor pain of arthritis or as directed by your doctor

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each tablet)
Aspirin 325 mg (NSAID*)

*nonsteroidal anti-inflammatory drug

OTC - PURPOSE SECTION

Purpose

Pain reliever

INDICATIONS AND USAGE

INDICATIONS & USAGE SECTION

Uses

for the temporary relief of minor aches and pains due to

  • headache
  • colds
  • menstrual pain
  • muscle pain
  • toothache
  • minor pain of arthritis

or as directed by your doctor

WARNINGS SECTION

Warnings

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
  • shock
  • asthma (wheezing)

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
  • have 3 or more alcoholic drinks every day while using this product
  • take more or for a longer time than directed
  • take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)

OTC - DO NOT USE SECTION

Do not use

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

OTC - ASK DOCTOR SECTION

Ask a doctor before use if

  • stomach bleeding warning applies to you
  • you have a history of stomach problems, such as heartburn
  • you have asthma
  • you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
  • you are taking a diuretic
  • you have not been drinking fluids
  • you have lost a lot of fluid due to vomiting or diarrhea

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are

  • taking a prescription drug for diabetes, gout, or arthritis
  • taking any other drug
  • under a doctor's care for any serious condition

OTC - STOP USE SECTION

Stop use and ask a doctor if

you experience any of the following signs of stomach bleeding:

  • feel faint
  • have bloody or black stools
  • vomit blood
  • 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 in the painfull area

any new symptoms appear

ringing in the ears or a loss of hearing occurs

OTC - PREGNANCY OR BREAST FEEDING SECTION

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 casue problems in the unborn child or complications during delivery.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

Directions

drink a full glass of water with each dose

  • adults and children 12 years and over: take 1 to 2 tablets every 4 hours while symptoms last. Do not take more than 12 tablets in 24 hours unless directed by a doctor
  • children under 12 years: consult a doctor

OTHER SAFETY INFORMATION

Other information

  • store at 25°C (77°F) excursions permitted between 15°-30°C (59°-86°F)
  • use by expiration date on package

INACTIVE INGREDIENT SECTION

Inactive ingredients corn starch, croscramellose sodium, hypromellose, microcrystalline cellulose, mineral oil, titanium dioxide

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

timely-aspirin325-300stimely-aspirin325-300s11R-TCL-Aspirin 325 mg-bulk label11R-TCL-Aspirin 325 mg-bulk label11R-TCL-Aspirin 325 mg-bottle label-1000s11R-TCL-Aspirin 325 mg-bottle label-1000s11R-TCL-Aspirin 325 mg-bottle label-100s11R-TCL-Aspirin 325 mg-bottle label-100s

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
212033aspirin 325 MG Oral TabletPSN4
212033aspirin 325 MG Oral TabletSCD4
212033ASA 325 MG Oral TabletSY4

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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49483-011-00ASPIRIN100000 in 1 CARTONTABLET, COATED1000004
49483-011-01ASPIRIN100 in 1 BOTTLE, PLASTICTABLET, COATED1004
49483-011-10ASPIRIN1000 in 1 BOTTLE, PLASTICTABLET, COATED10004
49483-011-31ASPIRIN300 in 1 BOTTLETABLET, COATED3004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49483-011ASPIRIN TABLET, COATED [TIME CAP LABS INC]4Current NDC, Legacy NDC, 4 package rows20231123_fe12519c-3e5f-4592-bd34-2d6b81b981f4.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49483-011-01EA - Each49483-0111a8b4a59-e054-44a3-8315-d49574cf89e312012-07-24
49483-011-10EA - Each49483-011d996d20c-42cd-41a2-a29a-679d7f395c7612014-05-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ASPIRINACTIVE INGREDIENTR16CO5Y76E2
ASPIRINACTIVE MOIETYR16CO5Y76E2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61U2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH482
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WO2
MINERAL OILINACTIVE INGREDIENTT5L8T28FGP2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJ2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JP2

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49483-01149483-011-10, 49483-011-01, 49483-011-00, 49483-011-31

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 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 1 · 30 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, COATED / ORAL920 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
CROSCARMELLOSE SODIUMCROSCARMELLOSE SODIUMM28OL1HH48TABLET, COATED / ORAL224 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPTABLET, COATED / ORAL1.5 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJTABLET, COATED / ORAL256 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, COATED / ORAL920 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
CROSCARMELLOSE SODIUMCROSCARMELLOSE SODIUMM28OL1HH48TABLET, COATED / ORAL224 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJTABLET, COATED / ORAL256 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPTABLET, COATED / ORAL1.5 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
CROSCARMELLOSE SODIUMCROSCARMELLOSE SODIUMM28OL1HH48TABLET, COATED / ORAL224 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
CROSCARMELLOSE SODIUMCROSCARMELLOSE SODIUMM28OL1HH48TABLET, COATED / ORAL224 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPTABLET, COATED / ORAL1.5 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJTABLET, COATED / ORAL256 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPTABLET, COATED / ORAL1.5 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPTABLET, COATED / ORAL49 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOTABLET, COATED / ORAL58 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
CROSCARMELLOSE SODIUMCROSCARMELLOSE SODIUMM28OL1HH48TABLET, COATED / ORAL224 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJTABLET, COATED / ORAL256 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJTABLET, COATED / ORAL256 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPTABLET, COATED / ORAL49 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPTABLET, COATED / ORAL49 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOTABLET, COATED / ORAL58 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOTABLET, COATED / ORAL58 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, COATED / ORAL920 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, COATED / ORAL920 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, COATED / ORAL920 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPTABLET, COATED / ORAL49 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOTABLET, COATED / ORAL58 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPTABLET, COATED / ORAL1.5 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPTABLET, COATED / ORAL49 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOTABLET, COATED / ORAL58 mgExact identifier — unii+route+dosage form
5 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
ASPIRINASPIRINTIME CAP LABS INCfe12519c-3e5f-4592-bd34-2d6b81b981f42023-11-22WarningsExact identifier
ndc (package): 49483-011-31
ndc (package): 49483-011-10
ndc (package): 49483-011-00
ndc (package): 49483-011-01
ndc (product): 49483-011
ndc11 (package): 49483001110
ndc11 (package): 49483001101
ndc11 (package): 49483001131
ndc11 (package): 49483001100
spl id: 0acac93d-0f05-0658-e063-6294a90a83c3
spl set id: fe12519c-3e5f-4592-bd34-2d6b81b981f4

Reported adverse events (FAERS/openFDA)#

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