FDA.reportPublic FDA data

Aspirin

Manufacturer
REMEDYREPACK INC.
Effective date
2021-09-27
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 22:34:50

Label at a glance#

ProductAspirin Regular Strength
Active ingredientASPIRIN
Label structure9 sections

Indications and uses

temporarily relieves minor aches and pains due to: headache menstrual pain a cold toothache muscle pain minor pain of arthritis or as recommended by your doctor

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 to 2 tablets every 4 hours not to exceed 12 tablets in 24 hours unless directed by a doctor children under 12 years: do not use unless directed by a doctor

Storage and handling

store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F) see end flap for expiration date and lot number

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

Uses

INDICATIONS & USAGE SECTION

  • temporarily relieves minor aches and pains due to:
    • headache
    • menstrual pain
    • a cold
    • toothache
    • muscle pain
    • minor pain of arthritis
  • or as recommended by your doctor

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
  • hives
  • shock
  • asthma (wheezing)

Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you

  • take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]
  • are age 60 or older
  • have had stomach ulcers or bleeding problems
  • take a blood thinning (anticoagulant) or steroid drug
  • take more or for a longer time than directed
  • have 3 or more alcoholic drinks every day while using this product

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

  • stomach bleeding warning applies to you
  • you have a history of stomach problems, such as heartburn
  • you have asthma
  • 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
  • arthritis 
  • gout

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:
    • vomit blood
    • feel faint
    • have bloody or black stools
    • have stomach pain that does not get better
  • ringing in the ears or a loss of hearing occurs
  • new symptoms occur
  • pain gets worse or lasts more than 10 days
  • redness or swelling is present

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 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 and over: take 1 to 2 tablets every 4 hours not to exceed 12 tablets in 24 hours 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 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • see end flap for expiration date and lot number

Inactive ingredients

INACTIVE INGREDIENT SECTION

black iron oxide, cellulose, colloidal anhydrous silica, corn starch, D&C yellow #10 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, polydextrose, polyethylene glycol, polyvinyl acetate phthalate, propylene glycol, shellac wax, simethicone, sodium alginate, sodium bicarbonate, stearic acid, talc, titanium dioxide, triacetin, triethyl citrate

Questions or comments?

OTC - QUESTIONS SECTION

1-800-645-2158

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DRUG: AspirinRegular Strength Regular Strength

GENERIC: Aspirin

DOSAGE: TABLET, COATED

ADMINSTRATION: ORAL

NDC: 70518-2684-0

COLOR: orange

SHAPE: ROUND

SCORE: No score

SIZE: 10 mm

IMPRINT: 44;227

PACKAGING: 30 in 1 BLISTER PACK

ACTIVE INGREDIENT(S):

  • ASPIRIN 325mg in 1

INACTIVE INGREDIENT(S):

  • SHELLAC
  • DIMETHICONE
  • TRIETHYL CITRATE
  • TRIACETIN
  • TITANIUM DIOXIDE
  • TALC
  • STEARIC ACID
  • SODIUM BICARBONATE
  • SODIUM ALGINATE
  • WATER
  • POWDERED CELLULOSE
  • Polyvinyl Acetate Phthalate
  • POLYETHYLENE GLYCOL, UNSPECIFIED
  • POLYDEXTROSE
  • HYPROMELLOSE, UNSPECIFIED
  • FD&C YELLOW NO. 6
  • D&C YELLOW NO. 10 ALUMINUM LAKE
  • STARCH, CORN
  • SILICON DIOXIDE
  • PROPYLENE GLYCOL
  • FERROSOFERRIC OXIDE

Remedy_LabelRemedy_Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70518-2684-02025-09-11C16284748780-1f386c649-bc01-0266-e053-dadaa90a7c1aRugby 44-227
70518-2684-02023-01-30C16284748780-1f386c649-bc01-0266-e053-dadaa90a7c1aRugby 44-227

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-2684ASPIRIN REGULAR STRENGTH (ASPIRIN) TABLET, COATED [REMEDYREPACK INC.]4Legacy NDC20210928_8381ccab-81dc-4a66-95bf-165d6a97fc57.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0536-1232-01EA - Each0536-123219667f61-f8a3-4dc5-ae98-d510ce69983812019-08-06

Products#

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

DailyMed product names page 1 of 1 · 23 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70518-268470518-2684-0
0536-1232

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 22 matching rows.

Name, UNII, Kind table
NameUNIIKind
FERROSOFERRIC OXIDEXM0M87F357IACT
SILICON DIOXIDEETJ7Z6XBU4IACT
STARCH, CORNO8232NY3SJIACT
D&C YELLOW NO. 10 ALUMINUM LAKECQ3XH3DET6IACT
FD&C YELLOW NO. 6H77VEI93A8IACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
POLYDEXTROSEVH2XOU12IEIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
POLYVINYL ACETATE PHTHALATE58QVG85GW3IACT
PROPYLENE GLYCOL6DC9Q167V3IACT
SHELLAC46N107B71OIACT
SODIUM ALGINATEC269C4G2ZQIACT
SODIUM BICARBONATE8MDF5V39QOIACT
STEARIC ACID4ELV7Z65APIACT
TALC7SEV7J4R1UIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
TRIACETINXHX3C3X673IACT
TRIETHYL CITRATE8Z96QXD6UMIACT
DIMETHICONE92RU3N3Y1OIACT
WATER059QF0KO0RIACT
POWDERED CELLULOSESMD1X3XO9MIACT
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
Aspirin Regular StrengthASPIRINRugby Laboratories939fce7e-55df-4dc5-916b-a533448e962f2026-05-08WarningsExact identifier
ndc (product): 0536-1232
dc8c3f4a-2200-ca38-e053-2a95a90a85208381ccab-81dc-4a66-95bf-165d6a97fc572023-10-16WarningsExact identifier
spl set id: 8381ccab-81dc-4a66-95bf-165d6a97fc57

Reported adverse events (FAERS/openFDA)#

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