FDA.reportPublic FDA data

Extra Strength Aspirin 325 mg

Manufacturer
HealthLife of USA LLC | HHH PHARMA USA, LLC dba/HHH Pharmaceuticals | Elysium Pharmaceuticals Ltd
Effective date
2026-10-03
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
daily-update
Hydrated at
2026-10-07 01:02:03

Label at a glance#

ProductExtra Strength Aspirin 325 mg
Active ingredientASPIRIN
Label structure9 sections

Indications and uses

temporary relieves minor aches and pains due to: headache muscular aches backache minor pain of arthritis the common cold toothache premenstrual and menstrual cramps

Dosage and administration

do not take more than directed drink a full glass of water with each dose adults and children 12 years of age 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 • do not use for more than 10 days unless directed by a doctor children under 12 years: do not use unless directed by a doctor

Storage and handling

store at controlled room temperature 25ºC (77ºF) execursion permitted between 15-30ºC (59-86ºF) TEMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Label contents#

Full prescribing information#

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Aspirin 325 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Purpose

OTC - PURPOSE SECTION

Pain reliever/Fever reducer

Uses

INDICATIONS & USAGE SECTION

temporary relieves minor aches and pains due to:

  • headache
  • muscular aches
  • backache
  • minor pain of arthritis
  • the common cold
  • toothache
  • premenstrual and menstrual cramps

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

Ask a doctor before use if

OTC - ASK DOCTOR SECTION

  • you have asthma
  • 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

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

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

Stop use and ask a doctor if

OTC - STOP USE SECTION

If

  • 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 for 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 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 (1-800-222-1222) right away. 

Directions

DOSAGE & ADMINISTRATION SECTION

  • do not take more than directed
  • drink a full glass of water with each dose
  • adults and children 12 years of age 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
    • do not use for more than 10 days unless directed by a doctor
  • children under 12 years:do not use unless directed by a doctor

Other information

STORAGE AND HANDLING SECTION

  • store at controlled room temperature 25ºC (77ºF) execursion permitted between 15-30ºC (59-86ºF)
  • TEMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Inactive ingredients

INACTIVE INGREDIENT SECTION

Colloidal Silicon Dioxide, Corn Starch, Hydroxypropyl Methylcellulose, Microcrystalline Cellulose, Polyethylene Glycol, Polyvinyl Alcohol, Povidone, Talc, Titanium Dioxide

Questions or comments?

OTC - QUESTIONS SECTION

Call toll free 1 844-832-1138

Monday through Friday 9AM - 5PM EST

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130369517002052GTIN-13: 0369517002052
EAN-13: 0369517002052
GTIN-12: 369517002052
UPC-A: 369517002052
GTIN storage (14 digits): 00369517002052		label.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69517-00269517-002-05

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
ASPIRINR16CO5Y76EACTIB
SILICON DIOXIDEETJ7Z6XBU4IACT
STARCH, CORNO8232NY3SJIACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
POLYVINYL ALCOHOL532B59J990IACT
POVIDONEFZ989GH94EIACT
TALC7SEV7J4R1UIACT
TITANIUM DIOXIDE15FIX9V2JPIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
12025-09-12full-release2026-06-01 01:13:44

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
3e97c632-9a87-674e-e063-6294a90a72a61d4fbc45-ef89-45ab-bc6d-41f30b468ac72025-09-12WarningsExact identifier
spl set id: 1d4fbc45-ef89-45ab-bc6d-41f30b468ac7

Reported adverse events (FAERS/openFDA)#

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