FDA.reportPublic FDA data

RUGBY 387R ASA TABLETS 81mg

Manufacturer
Bryant Ranch Prepack
Effective date
2020-10-26
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 23:09:53

Label at a glance#

ProductAspirin
Active ingredientASPIRIN
Label structure7 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient in Each tablet

Aspirin 81 mg (NSAID) Non-steroidal anti-inflammatory drug

INACTIVE INGREDIENT SECTION

Inactive ingredients: anhydrous lactose, carnauba wax, colloidal silicon dioxide, croscarmellose sodium, D-C yellow #10 aluminum lake, iron oxide ochre, methacrylic acid copolymer, microcrystalline cellulose, Polysorbate 80, simethicone, sodium hydroxide, sodium lauryl sulfate, talc, titanium dioxide

DOSAGE & ADMINISTRATION SECTION

Directions: drink a full glass of water with each dose; adults and children 12 years and over: take 4 to 8 tablets every 4 hours not to exceed 48 tablets in 24 hours unless directed by a doctor

Children under 12 years - consult a doctor

INDICATIONS & USAGE SECTION

Uses: temporarily relieves minor aches and pains: for other uses, see your doctor, but do not use for more than 10 days without consulting your doctor because serious side effects may occur.

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, shock, 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, 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.

HOW SUPPLIED

HOW SUPPLIED SECTION

Product: 71335-0195

NDC: 71335-0195-1 120 TABLET, COATED in a BOTTLE

NDC: 71335-0195-2 30 TABLET, COATED in a BOTTLE

NDC: 71335-0195-3 100 TABLET, COATED in a BOTTLE

NDC: 71335-0195-4 20 TABLET, COATED in a BOTTLE

NDC: 71335-0195-5 90 TABLET, COATED in a BOTTLE

NDC: 71335-0195-6 60 TABLET, COATED in a BOTTLE

NDC: 71335-0195-7 36 TABLET, COATED in a BOTTLE

Aspirin 81 mg EC Tablet

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label Image
Label Image

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71335-0195-12020-10-26C16284748780-19d75b9d0-1801-f424-e053-dadaa90a57ceRUGBY 387R ASA TABLETS 81mg
71335-0195-22020-10-26C16284748780-19d75b9d0-1801-f424-e053-dadaa90a57ceRUGBY 387R ASA TABLETS 81mg
71335-0195-32020-10-26C16284748780-19d75b9d0-1801-f424-e053-dadaa90a57ceRUGBY 387R ASA TABLETS 81mg
71335-0195-42020-10-26C16284748780-19d75b9d0-1801-f424-e053-dadaa90a57ceRUGBY 387R ASA TABLETS 81mg
71335-0195-52020-10-26C16284748780-19d75b9d0-1801-f424-e053-dadaa90a57ceRUGBY 387R ASA TABLETS 81mg
71335-0195-62020-10-26C16284748780-19d75b9d0-1801-f424-e053-dadaa90a57ceRUGBY 387R ASA TABLETS 81mg
71335-0195-72020-10-26C16284748780-19d75b9d0-1801-f424-e053-dadaa90a57ceRUGBY 387R ASA TABLETS 81mg
71335-0195-12020-01-31C16284748780-19d75b9d0-1801-f424-e053-dadaa90a57ceRUGBY 387R ASA TABLETS 81mg
71335-0195-22020-01-31C16284748780-19d75b9d0-1801-f424-e053-dadaa90a57ceRUGBY 387R ASA TABLETS 81mg
71335-0195-32020-01-31C16284748780-19d75b9d0-1801-f424-e053-dadaa90a57ceRUGBY 387R ASA TABLETS 81mg
71335-0195-42020-01-31C16284748780-19d75b9d0-1801-f424-e053-dadaa90a57ceRUGBY 387R ASA TABLETS 81mg
71335-0195-52020-01-31C16284748780-19d75b9d0-1801-f424-e053-dadaa90a57ceRUGBY 387R ASA TABLETS 81mg
71335-0195-62020-01-31C16284748780-19d75b9d0-1801-f424-e053-dadaa90a57ceRUGBY 387R ASA TABLETS 81mg
71335-0195-72020-01-31C16284748780-19d75b9d0-1801-f424-e053-dadaa90a57ceRUGBY 387R ASA TABLETS 81mg

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-0195-1EA - Each71335-019567ff7bb7-bcbc-4dfe-9813-ff9938c7912112018-03-08
71335-0195-2EA - Each71335-019542dcf4b7-e97b-49d1-bcc6-41b631bbd24112018-03-08
71335-0195-3EA - Each71335-0195ed3bc4a6-c686-417e-a775-be313d83399512018-03-08
71335-0195-4EA - Each71335-019581a0c511-f5c6-45ee-9950-2f2e7d873af112018-03-08
71335-0195-5EA - Each71335-019521bb2390-d6b2-4d1f-a92f-06c7d7a02c8812018-03-08
71335-0195-6EA - Each71335-0195c0401f56-9cb5-4e7c-bbb2-cd98889cd64a12018-03-08
71335-0195-7EA - Each71335-019571c37e88-1124-4349-938a-45b76de52c9012018-03-08
0536-1004-10EA - Each0536-1004e6fc73e7-c431-44a4-89ed-dee376ea3af712014-08-01
0536-1004-41EA - Each0536-1004624b839c-51f7-4f71-97ae-000937778c9d12014-09-03

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
71335-019571335-0195-6, 71335-0195-7, 71335-0195-1, 71335-0195-4, 71335-0195-5, 71335-0195-2, 71335-0195-3
0536-1004

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
CROSCARMELLOSE SODIUMM28OL1HH48IACT
CARNAUBA WAXR12CBM0EIZIACT
ANHYDROUS LACTOSE3SY5LH9PMKIACT
D&C YELLOW NO. 1035SW5USQ3GIACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE ANX76LV5T8JIACT
POLYSORBATE 806OZP39ZG8HIACT
SODIUM LAURYL SULFATE368GB5141JIACT
DIMETHICONE92RU3N3Y1OIACT
TALC7SEV7J4R1UIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
TRIETHYL CITRATE8Z96QXD6UMIACT
ASPIRINR16CO5Y76EACTIB
SILICON DIOXIDEETJ7Z6XBU4IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
a3149e1c-5dc7-4aa4-90fb-f025a1ac35aa9bf01998-e410-4670-bd31-b55b414e164e2023-01-13WarningsExact identifier
spl set id: 9bf01998-e410-4670-bd31-b55b414e164e

Reported adverse events (FAERS/openFDA)#

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