RUGBY 387R ASA TABLETS 81mg

Manufacturer: RUGBY | TIME CAP LABORATORIES, INC
Effective date: 2020-06-10
Label type: HUMAN OTC DRUG LABEL
Version: 5
Source: legacy-cache
Hydrated at: 2026-08-01 23:26:23

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 SECTION

Aspirin 81 mg tablets are supplied in: 120 and 1000 bottle counts

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

1000 ct

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0536-1004-10	EA - Each	0536-1004	e6fc73e7-c431-44a4-89ed-dee376ea3af7	1	2014-08-01
0536-1004-41	EA - Each	0536-1004	624b839c-51f7-4f71-97ae-000937778c9d	1	2014-09-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
aspirin	ACTIVE INGREDIENT	R16CO5Y76E	1
aspirin	ACTIVE MOIETY	R16CO5Y76E	1
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	1
BROWN IRON OXIDE	INACTIVE INGREDIENT	1N032N7MFO	1
CARNAUBA WAX	INACTIVE INGREDIENT	R12CBM0EIZ	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	1
COLLOIDAL SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	1
DIMETHICONE	INACTIVE INGREDIENT	92RU3N3Y1O	1
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A	INACTIVE INGREDIENT	NX76LV5T8J	1
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	1
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	1
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	1

Products#

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

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

ASPIRIN
CROSCARMELLOSE SODIUM
CARNAUBA WAX
ANHYDROUS LACTOSE
D&C YELLOW NO. 10
FERRIC OXIDE YELLOW
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A
POLYSORBATE 80
SODIUM LAURYL SULFATE
DIMETHICONE
TALC
TITANIUM DIOXIDE
TRIETHYL CITRATE
SILICON DIOXIDE
MICROCRYSTALLINE CELLULOSE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
0536-1004	0536-1004-10, 0536-1004-41

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
Name	UNII	Kind
CROSCARMELLOSE SODIUM	M28OL1HH48	IACT
CARNAUBA WAX	R12CBM0EIZ	IACT
ANHYDROUS LACTOSE	3SY5LH9PMK	IACT
D&C YELLOW NO. 10	35SW5USQ3G	IACT
FERRIC OXIDE YELLOW	EX438O2MRT	IACT
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A	NX76LV5T8J	IACT
POLYSORBATE 80	6OZP39ZG8H	IACT
SODIUM LAURYL SULFATE	368GB5141J	IACT
DIMETHICONE	92RU3N3Y1O	IACT
TALC	7SEV7J4R1U	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
TRIETHYL CITRATE	8Z96QXD6UM	IACT
ASPIRIN	R16CO5Y76E	ACTIB
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
MICROCRYSTALLINE CELLULOSE	OP1R32D61U	IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 10 · 566 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	POWDER / RESPIRATORY (INHALATION)	2 mg		Exact identifier — unii candidate 40 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	SOLUTION/ DROPS / TOPICAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	SUSPENSION / RESPIRATORY (INHALATION)		1 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	CAPSULE, COATED / ORAL	0.08 mg		Exact identifier — unii candidate 174 equally ranked IID candidates
ANHYDROUS LACTOSE	ANHYDROUS LACTOSE	3SY5LH9PMK	INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR	25 mg		Exact identifier — unii candidate 21 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, FOR SUSPENSION / ORAL		20100 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
ANHYDROUS LACTOSE	ANHYDROUS LACTOSE	3SY5LH9PMK	TABLET, FOR SUSPENSION / ORAL		15 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL		34 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	GEL / OPHTHALMIC		6 mg	Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	SOLUTION / INTRAVENOUS	2.78 %w/v		Exact identifier — unii candidate 174 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	CAPSULE, DELAYED RELEASE / ORAL		23 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
COLLOIDAL SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	POWDER / ORAL		602 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A	METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A	NX76LV5T8J	CAPSULE, COATED PELLETS / ORAL		32 mg	Exact identifier — unii candidate 13 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	POWDER, FOR SUSPENSION / ORAL		4441 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
COLLOIDAL SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	CAPSULE, LIQUID FILLED / ORAL		106 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
BROWN IRON OXIDE	BROWN IRON OXIDE	1N032N7MFO	CAPSULE / ORAL	NA		Exact identifier — unii candidate 3 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	AEROSOL, METERED / RESPIRATORY (INHALATION)	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET / SUBLINGUAL	43.2 mg		Exact identifier — unii candidate 28 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRATHECAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
CROSCARMELLOSE SODIUM	CROSCARMELLOSE SODIUM	M28OL1HH48	TABLET, COATED / ORAL		224 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
COLLOIDAL SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	PELLET / ORAL		34 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
CROSCARMELLOSE SODIUM	CROSCARMELLOSE SODIUM	M28OL1HH48	PELLET / ORAL		162 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	SPONGE / TOPICAL	5 %w/w		Exact identifier — unii candidate 42 equally ranked IID candidates
COLLOIDAL SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	CREAM / VAGINAL		51 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, CHEWABLE / ORAL		1725 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	ENEMA / RECTAL	0.44 %v/v		Exact identifier — unii candidate 174 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	SOLUTION / RECTAL		315 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, ORALLY DISINTEGRATING / ORAL		1800 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION / DENTAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
D&C YELLOW NO. 10	D&C YELLOW NO. 10	35SW5USQ3G	TABLET / ORAL	80 mg		Exact identifier — unii candidate 31 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	INJECTION / INTRA-ARTICULAR		4 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	SOLUTION / INTRAOCULAR	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION, POWDER, FOR SOLUTION / INTRADERMAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
COLLOIDAL SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL		69 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
D&C YELLOW NO. 10	D&C YELLOW NO. 10	35SW5USQ3G	CAPSULE, LIQUID FILLED / ORAL	1.51 mg		Exact identifier — unii candidate 31 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	CAPSULE, EXTENDED RELEASE / ORAL		10 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION, SOLUTION / INTRAVASCULAR	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
CROSCARMELLOSE SODIUM	CROSCARMELLOSE SODIUM	M28OL1HH48	INJECTION / INTRAMUSCULAR	1 %w/v		Exact identifier — unii candidate 22 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION, POWDER, FOR SOLUTION / INTRADISCAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION / INTRASYNOVIAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	INJECTION / INTRAVENOUS		4680 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	TABLET / ORAL	1000 mg		Exact identifier — unii candidate 35 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTABLE, LIPOSOMAL / INTRAVENOUS	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	SOLUTION / ORAL		9120 mg	Exact identifier — unii candidate 174 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	CREAM / TOPICAL		20 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	SUSPENSION, EXTENDED RELEASE / ORAL		1120 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, FILM COATED / ORAL		36 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
TRIETHYL CITRATE	TRIETHYL CITRATE	8Z96QXD6UM	TABLET, EXTENDED RELEASE / ORAL		160 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
CARNAUBA WAX	CARNAUBA WAX	R12CBM0EIZ	CAPSULE, EXTENDED RELEASE / ORAL		288 mg	Exact identifier — unii candidate 11 equally ranked IID candidates
CARNAUBA WAX	CARNAUBA WAX	R12CBM0EIZ	TABLET, EXTENDED RELEASE / ORAL		2150 mg	Exact identifier — unii candidate 11 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	TABLET, FILM COATED / ORAL		8 mg	Exact identifier — unii candidate 174 equally ranked IID candidates
TRIETHYL CITRATE	TRIETHYL CITRATE	8Z96QXD6UM	CAPSULE, EXTENDED RELEASE / ORAL		129 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
D&C YELLOW NO. 10	D&C YELLOW NO. 10	35SW5USQ3G	SOLUTION / ORAL		8 mg	Exact identifier — unii candidate 31 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION / INTRATHECAL	176 mg		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION, SUSPENSION / INTRAMUSCULAR	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION / INTRASPINAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
CROSCARMELLOSE SODIUM	CROSCARMELLOSE SODIUM	M28OL1HH48	TABLET, ORALLY DISINTEGRATING / ORAL		184 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
COLLOIDAL SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET / ORAL		750 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
COLLOIDAL SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	CAPSULE, DELAYED RELEASE / ORAL		40 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	CAPSULE, COATED PELLETS / ORAL	2 mg		Exact identifier — unii candidate 78 equally ranked IID candidates

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
f272110d-0cd7-aa2c-e053-2995a90aedc1			dfc4332b-aca4-4a27-973d-6956d625f9ce	2023-01-17	Warnings	Exact identifier spl set id: dfc4332b-aca4-4a27-973d-6956d625f9ce

Reported adverse events (FAERS/openFDA)#

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