FDA.reportPublic FDA data

ASPIRIN

Manufacturer
REMEDYREPACK INC.
Effective date
2019-02-11
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-02 00:31:19

Label at a glance#

ProductASPIRIN
Active ingredientASPIRIN
Label structure8 sections

Indications and uses

For the temporary relief of aches and pains due to: headache, colds,menstral pain, muscle pain, toothache,minor pain of arthritis or as directed by your doctor

Dosage and administration

Drink a full glass of water with each doses 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.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION


Each tablet contains Aspirin 325 mg (NSAID)

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Corn Starch, Croscramellose Sodium, Hypromellose, Microcrystalline Cellulose, Mineral Oil, Titanium Dioxide

PURPOSE

OTC - PURPOSE SECTION

Pain Reliever

DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

Drink a full glass of water with each doses

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.

INDICATIONS AND USAGE

INDICATIONS & USAGE SECTION

For the temporary relief of aches and pains due to:

headache, colds,menstral pain, muscle pain, toothache,minor pain of arthritis or as directed by your doctor

WARNINGS

WARNINGS SECTION

Reyes'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 reactin, which may include hives, facial swelling, shock, asthma (wheezing)

Stomach bleeding warning:  This produc tcontains 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 non prescription 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.

KEEP OUT OF THE REACH OF CHILDREN

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.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DRUG: ASPIRIN

GENERIC: ASPIRIN

DOSAGE: TABLET, COATED

ADMINSTRATION: ORAL

NDC: 70518-0030-0

COLOR: white

SHAPE: ROUND

SCORE: No score

SIZE: 10 mm

IMPRINT: TCL011

PACKAGING: 30 in 1 BLISTER PACK

ACTIVE INGREDIENT(S):

  • ASPIRIN 325mg in 1

INACTIVE INGREDIENT(S):

  • CELLULOSE, MICROCRYSTALLINE
  • HYPROMELLOSES
  • MINERAL OIL
  • CROSCARMELLOSE SODIUM
  • STARCH, CORN
  • TITANIUM DIOXIDE

Remedy_LabelRemedy_Label

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

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
70518-003070518-0030-0
49483-011

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
STARCH, CORNO8232NY3SJIACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
HYPROMELLOSES3NXW29V3WOIACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
MINERAL OILT5L8T28FGPIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
ASPIRINR16CO5Y76EACTIB

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
ASPIRINASPIRINTIME CAP LABS INCfe12519c-3e5f-4592-bd34-2d6b81b981f42023-11-22WarningsExact identifier
ndc (product): 49483-011
983d7e8d-38b2-482a-e053-2995a90a60d5dbdc8421-bc24-4bac-9bb2-12e6b1e29f132019-11-26WarningsExact identifier
spl set id: dbdc8421-bc24-4bac-9bb2-12e6b1e29f13

Reported adverse events (FAERS/openFDA)#

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