Aspirin

Manufacturer
Aphena Pharma Solutions - Tennessee, LLC
Effective date
2018-02-18
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:54:40

Label at a glance#

ProductAspirin
Active ingredientASPIRIN
Label structure11 sections

Indications and uses

temporarily relieves headache menstrual pain muscle pain toothache minor pain or arthritis pain and fever of colds

Dosage and administration

DRINK A FULL GLASS OF WATER WITH EACH DOSE adults and children 12 years and over : 1-2 tablets every 4 hours while symptoms last, but not more than 12 tablets in 24 hours. Children under 12 years: ask a doctor

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

(in each tablet)

Aspirin 325 mg (NSAID) *

*nonsteroidal anti-inflammatory drug

Purpose

OTC - PURPOSE SECTION

Pain reliever/ Fever Reducer

Uses

INDICATIONS & USAGE SECTION

temporarily relieves

  • headache
  • menstrual pain
  • muscle pain
  • toothache
  • minor pain or arthritis
  • pain and fever of colds

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 signs of  Reye’s syndrome, a rare but serious illness.

Allergy Alert: Aspirin may cause a severe allergic reaction which may include

  • hives
  • asthma (wheezing)
  • shock
  • facial swelling

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

    Do not use

  • if you have ever had an allergic reaction to any other pain reliever / fever reducer

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

    Stop use and ask a doctor if

  • you experiences 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 in the painful area
  • any new symptoms appear
  • ringing in the ears or a 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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

DRINK A FULL GLASS OF WATER WITH EACH DOSE

  • adults and children 12 years and over : 1-2 tablets every 4 hours while symptoms last, but not more than 12 tablets in 24 hours.
  • Children under 12 years: ask a doctor

Other Information

SPL UNCLASSIFIED SECTION

  • avoid excessive heat or humidity
  • store at 15-30 °C (59-86 °F)

Inactive Ingredients

INACTIVE INGREDIENT SECTION

croscarmellose sodium, D&C Yellow #10 (Al-Lake), FD&C yellow #6 (Al-Lake), HPMC, methacrylic acid copolymer, polyethylene glycol, propylene glycol, PVP,  sodium lauryl sulfate, starch, stearic acid, talc, titanium dioxide

Questions or Comments

OTC - QUESTIONS SECTION

Call 631-981-4600, 8.30am – 4.30 pm ET Monday-Friday

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Manufactured by: Advance Pharmaceutical, Inc. Holtsville, NY 11742

Repackaging Information

SPL UNCLASSIFIED SECTION

Please reference the How Supplied section listed above for a description of individual tablets. This drug product has been received by Aphena Pharma - TN in a manufacturer or distributor packaged configuration and repackaged in full compliance with all applicable cGMP regulations. The package configurations available from Aphena are listed below:

Count325mg
10071610-034-65

Store between 20°-25°C (68°-77°F). See USP Controlled Room Temperature. Dispense in a tight light-resistant container as defined by USP. Keep this and all drugs out of the reach of children.

Repackaged by:
Aphena Pharma Solutions - TNAphena Pharma Solutions - TN
Cookeville, TN 38506

20180218JH

PRINCIPAL DISPLAY PANEL - 325mg

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 71610-034 - Aspirin EC (NSAID) 325mg - Rx Only
Bottle Label 325mgBottle Label 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
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 Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71610-034-65Aspirin100 in 1 BOTTLETABLET1001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-034ASPIRIN TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1Current NDC, Legacy NDC, 1 package rows20180221_49f46b08-b2fe-4e4d-b235-983dab9740cc.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-034-65EA - Each71610-034dbd21456-d441-4492-bdd5-9ef29a40833e12018-04-19
54738-111-01EA - Each54738-1117b3d4297-0e62-466c-afc5-680c41f0bf2412019-01-24
54738-111-03EA - Each54738-111d60bdf92-8a0c-438a-ac19-c0b5ca60059412019-01-24

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71610-03471610-034-65
54738-111

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AspirinASPIRINAphena Pharma Solutions - Tennessee, LLC49f46b08-b2fe-4e4d-b235-983dab9740cc2018-02-18WarningsExact identifier
ndc (package): 71610-034-65
ndc (product): 71610-034
ndc11 (package): 71610003465
spl id: d18746db-ee0c-4e00-b4b1-dfd10e32d1b3
spl set id: 49f46b08-b2fe-4e4d-b235-983dab9740cc
AspirinASPIRINRichmond Pharmaceuticals, Inc236a5672-556a-4d8f-9bb6-5877e363e7472017-10-30WarningsExact identifier
ndc (product): 54738-111

Reported adverse events (FAERS/openFDA)#

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