ASPIRIN 325 MG EC TABLET

Manufacturer
NuCare Pharmaceuticals,Inc.
Effective date
2017-09-06
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:12:21

Label at a glance#

ProductASPIRIN 325 MG EC
Active ingredientASPIRIN
Label structure20 sections

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, not more than 12 tablets in 24 hours children under 12 years: ask a doctor

Storage and handling

store at room temperature 15°-30ºC (59°-86°F)

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Aspirin USP, 325 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

OTC - PURPOSE SECTION

Pain Reliever/Fever Reducer

INDICATIONS & USAGE SECTION

temporarily relieves

  • headache
  • menstrual pain
  • minor pain of arthritis
  • muscle pain
  • toothache
  • 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 prodcut, 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.

OTHER SAFETY INFORMATION

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

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

OTHER SAFETY INFORMATION

Stomach bleeding warning: This prodcut 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 (ibuprofen, naproxen, or others)
  • take more or for a longer time than directed
  • have 3 or more alcoholic drinks every day while using this product

Drug Facts continued on back of label

OTC - DO NOT USE SECTION

Do not use if you have ever had an allergic reaction to 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 high blood pressure, heart disease, liver cirrhosis, or kidney disease
  • you are taking a diuretic
  • you have asthma

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are

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

OTC - STOP USE SECTION

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

  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasta more than 3 days
  • redness or swelling is present in the painful area
  • any new symptoms appear
  • ringing in the ears or loss of hearing occurs

These could be sings of a serious condition

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use. It is especially imporant 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.

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.

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, not more than 12 tablets in 24 hours
  • children under 12 years: ask a doctor

Other information

STORAGE AND HANDLING SECTION

  • store at room temperature 15°-30ºC (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, povidone, sodium lauryl sulfate, starch, stearic acid, talc, titanium dioxide

Questions or comments?

OTC - QUESTIONS SECTION

Questions or comments ? call 516-341-0666, 8:30 am - 4:30 pm ET, Monday - Friday

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

*Reliable 1 Laboratories LLC is not affiliated with the owner of the trademark Ecotrin®.

Distributed by: Reliable 1 Laboratories LLC, Valley Stream, NY 11580

www.reliable1labs.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

pdppdp

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68071-4081-12020-06-02C16284748780-19d75b9d0-b875-f424-e053-dadaa90a57ceASPIRIN 325 MG EC TABLET
68071-4081-12020-01-31C16284748780-19d75b9d0-b875-f424-e053-dadaa90a57ceASPIRIN 325 MG EC TABLET

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69618-015-01EA - Each69618-015296184d8-b7d1-4a4a-b254-1207752766ee12016-03-04
69618-015-10EA - Each69618-01534634cc6-a414-446f-891f-aba33a29692e12016-03-04

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68071-408168071-4081-1
69618-015

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
ASPIRIN 325 MG ECASPIRINReliable 1 Laboratories LLC2ab8564f-f958-7512-e054-00144ff88e882025-01-15WarningsExact identifier
ndc (product): 69618-015
a68f7860-a504-60c8-e053-2995a90a728a588a8ffd-1bd6-ae6c-e053-2a91aa0af15e2020-05-26WarningsExact identifier
spl set id: 588a8ffd-1bd6-ae6c-e053-2a91aa0af15e

Reported adverse events (FAERS/openFDA)#

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