FDA.reportPublic FDA data

Aspirin - Bi-Mart | Elysium Pharmaceuticals Ltd

Manufacturer
Bi-Mart | Elysium Pharmaceuticals Ltd
Effective date
2026-11-05
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
daily-update
Hydrated at
2026-11-10 04:04:44

Label at a glance#

ProductAspirin
Active ingredientASPIRIN
Label structure9 sections

Indications and uses

temporary relieves minor aches and pains due to: minor pain of arthritis headache muscle pain the common cold menstrual pain toothache temporarily reduces fever

Dosage and administration

do not take more than directed drink a full glass of water with each dose adults and children 12 years and over:  take 1 or 2 tablets every 4 hours or 3 tablets every 6 hours, not to exceed 12 tablets in 24 hours unless directed by a doctor children under 12 years:  do not useunless directed by a doctor

Storage and handling

store between 20⁰ to 25⁰C (68⁰ to 77⁰F) TAMPER 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:

  • minor pain of arthritis
  • headache
  • muscle pain
  • the common cold
  • menstrual pain
  • toothache
  • temporarily reduces fever

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:

  • facial swelling
  • shock
  • hives
  • 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]

Do not use

OTC - DO NOT USE SECTION

  • if you are allergic to aspirin or any other pain reliever/fever reducer
  • if you have ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if

OTC - ASK DOCTOR SECTION

  • you are taking a diuretic
  • 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 have asthma

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

taking a prescription drug for 

  • gout
  • diabetes 
  • arthritis

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • 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
  • ringing in the ears or a loss of hearing occurs
  • 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

These could be signs of a serious condition.

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 at 20 weeks or later in 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 and over: take 1 or 2 tablets every 4 hours or 3 tablets every 6 hours, not to exceed 12 tablets in 24 hours unless directed by a doctor
  • children under 12 years: do not useunless directed by a doctor

Other information

STORAGE AND HANDLING SECTION

  • store between 20⁰ to 25⁰C (68⁰ to 77⁰F)
  • TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

Inactive ingredients

INACTIVE INGREDIENT SECTION

corn starch, croscarmellose sodium, microcrystalline cellulose, polyvinyl alcohol, talc, titanium dioxide

Questions?

OTC - QUESTIONS SECTION

call toll-free 1-844-912-4012

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display Panel

11

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

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
37835-57737835-577-01, 37835-577-25

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
ASPIRINR16CO5Y76EACTIB
CROSCARMELLOSE SODIUMM28OL1HH48IACT
STARCH, CORNO8232NY3SJIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
POLYVINYL ALCOHOL532B59J990IACT
TALC7SEV7J4R1UIACT
TITANIUM DIOXIDE15FIX9V2JPIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
12025-08-01full-release2026-06-01 01:10:44

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
AspirinASPIRINBi-Martcc5db55a-a2b0-48f4-802b-9e5e94fd9ceb2025-08-01WarningsExact identifier
ndc (package): 37835-577-01
ndc (package): 37835-577-25
ndc (product): 37835-577
ndc11 (package): 37835057701
ndc11 (package): 37835057725
spl set id: cc5db55a-a2b0-48f4-802b-9e5e94fd9ceb

Reported adverse events (FAERS/openFDA)#

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