Aspirin

Manufacturer: CARDINAL HEALTH | Pharbest Pharmaceuticals, Inc.
Effective date: 2017-11-11
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: legacy-cache
Hydrated at: 2026-08-02 01:09:13

Label at a glance#

ProductAspirin

Active ingredientASPIRIN

Label structure9 sections

Indications and uses

for the temporary relief of minor aches and pains or as recommneded by your doctor. Because of its delayed action, this product will not provide fast relief of headaches or other symptoms needing immediate relief. ask your doctor about other uses for this product

Dosage and administration

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

Storage and handling

store at room temperature save carton for full direction and warnings

Contacts and useful links#

PhonePoison Help1-800-222-1222

PhoneLabel contact(866) 562-2756

Label contents#

Full prescribing information#

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Aspirin 81mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Purpose

OTC - PURPOSE SECTION

Pain reliever

Uses

INDICATIONS & USAGE SECTION

for the temporary relief of minor aches and pains or as recommneded by your doctor. Because of its delayed action, this product will not provide fast relief of headaches or other symptoms needing immediate relief.

ask your doctor about other uses for this product

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
take other drugs containing prescription or nonprescription 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

Do not use

OTC - DO NOT USE SECTION

if you are allergic to aspirin or any other pain reliever/fever reducer.

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 are taking a diuretic
you have asthma
you have high blood pressure, heart disease, liver cirrhosis or kidney disease

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
any new symptoms occur
pain gets worse or lasts more than 10 days
redness or swelling is present
ringing in the ears or loss of hearing occurs

These could be signs of a serious illness.

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 accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

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

Other information

STORAGE AND HANDLING SECTION

store at room temperature
save carton for full direction and warnings

Inactive ingredients

INACTIVE INGREDIENT SECTION

croscarmellose sodium, D&C yellow# 10 Lake, FD&C yellow# 6, hypromellose, lactose, methcrylic acid copolymer, microcrystaline cellulose, silicon dioxide, sodium bicarbonate, sodium lauryl sulfate, starch, talc, titanium dioxide, triacetin, triethlyl citrate

Questions or comments?

OTC - QUESTIONS SECTION

Adverse drug event call: (866) 562-2756

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 49781-097-52

LEADER

^†Compare to Bayer^®low dose aspirin active ingredient

LEADER

^#ASPIRIN REGIMEN

Aspirin 81 mg

Pain Reliever (NSAID)

Low Dose Safety Coated

120 ENTERIC COATED TABLETS

image of label

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
49781-097-52	EA - Each	49781-097	dcc7cefb-b2d2-4d3d-ab01-5412cf4b941f	1	2016-07-19
49781-097-58	EA - Each	49781-097	ea01a990-9b7e-4821-a4c8-534b1d0f91f9	1	2016-12-07

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
ASPIRIN	ACTIVE INGREDIENT	R16CO5Y76E	1
ASPIRIN	ACTIVE MOIETY	R16CO5Y76E	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	1
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	1
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)	INACTIVE INGREDIENT	74G4R6TH13	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	1
SODIUM BICARBONATE	INACTIVE INGREDIENT	8MDF5V39QO	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	1
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	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 · 16 matching rows.

Aspirin
CROSCARMELLOSE SODIUM
D&C YELLOW NO. 10
STARCH, CORN
HYPROMELLOSES
LACTOSE
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)
CELLULOSE, MICROCRYSTALLINE
SODIUM BICARBONATE
SODIUM LAURYL SULFATE
TALC
TITANIUM DIOXIDE
TRIACETIN
TRIETHYL CITRATE
FD&C YELLOW NO. 6
SILICON DIOXIDE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
49781-097	49781-097-52, 49781-097-58

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
ASPIRIN	R16CO5Y76E	ACTIB
CROSCARMELLOSE SODIUM	M28OL1HH48	IACT
D&C YELLOW NO. 10	35SW5USQ3G	IACT
STARCH, CORN	O8232NY3SJ	IACT
HYPROMELLOSES	3NXW29V3WO	IACT
LACTOSE	J2B2A4N98G	IACT
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)	74G4R6TH13	IACT
CELLULOSE, MICROCRYSTALLINE	OP1R32D61U	IACT
SODIUM BICARBONATE	8MDF5V39QO	IACT
SODIUM LAURYL SULFATE	368GB5141J	IACT
TALC	7SEV7J4R1U	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
TRIACETIN	XHX3C3X673	IACT
TRIETHYL CITRATE	8Z96QXD6UM	IACT
FD&C YELLOW NO. 6	H77VEI93A8	IACT
SILICON DIOXIDE	ETJ7Z6XBU4	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 8 · 441 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	SUSPENSION / ORAL		305 mg	Exact identifier — unii candidate 27 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	GRANULE, FOR SUSPENSION / ORAL	512.5 mg/5ml		Exact identifier — unii candidate 36 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	GEL / NASAL		20 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
FD&C YELLOW NO. 6	FD&C YELLOW NO. 6	H77VEI93A8	CONCENTRATE / ORAL	0.03 mg/5ml		Exact identifier — unii candidate 34 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	CAPSULE / ORAL		72 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)	METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)	74G4R6TH13	TABLET, DELAYED RELEASE / ORAL		172 mg	Exact identifier — unii candidate 8 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
TRIETHYL CITRATE	TRIETHYL CITRATE	8Z96QXD6UM	TABLET, FILM COATED / ORAL		3 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
D&C YELLOW NO. 10	D&C YELLOW NO. 10	35SW5USQ3G	SOAP / TOPICAL	1.4 %w/w		Exact identifier — unii candidate 31 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	TABLET / ORAL		233 mg	Exact identifier — unii candidate 42 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	TABLET, EFFERVESCENT / ORAL	1.5 mg		Exact identifier — unii candidate 42 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	POWDER / RESPIRATORY (INHALATION)	NA		Exact identifier — unii candidate 42 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	CREAM / TOPICAL		214 mg	Exact identifier — unii candidate 42 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	FILM / BUCCAL		3 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
TRIACETIN	TRIACETIN	XHX3C3X673	TABLET, COATED / ORAL	1 mg		Exact identifier — unii candidate 14 equally ranked IID candidates
SODIUM BICARBONATE	SODIUM BICARBONATE	8MDF5V39QO	INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR	1000 mg		Exact identifier — unii candidate 34 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	TABLET, EXTENDED RELEASE / ORAL		300 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	TABLET, FOR SUSPENSION / ORAL		264 mg	Exact identifier — unii candidate 42 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	PASTE / DENTAL	1.5 %w/w		Exact identifier — unii candidate 42 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	TABLET / ORAL	1000 mg		Exact identifier — unii candidate 35 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	CAPSULE / ORAL		729 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
D&C YELLOW NO. 10	D&C YELLOW NO. 10	35SW5USQ3G	CAPSULE, EXTENDED RELEASE / ORAL		3 mg	Exact identifier — unii candidate 31 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	SHAMPOO / TOPICAL	3 %w/w		Exact identifier — unii candidate 27 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE, DELAYED RELEASE PELLETS / ORAL		24 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	TABLET / SUBLINGUAL	1.1 mg		Exact identifier — unii candidate 42 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET / BUCCAL		18 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	FILM, SOLUBLE / ORAL		2 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		11 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	CAPSULE, DELAYED RELEASE / ORAL		105 mg	Exact identifier — unii candidate 27 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	TABLET / SUBLINGUAL		352 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
FD&C YELLOW NO. 6	FD&C YELLOW NO. 6	H77VEI93A8	TABLET, ORALLY DISINTEGRATING / ORAL		12 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
SODIUM BICARBONATE	SODIUM BICARBONATE	8MDF5V39QO	POWDER, FOR SOLUTION / ORAL	1250 mg/100ml		Exact identifier — unii candidate 34 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, EXTENDED RELEASE / ORAL		90 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, FILM COATED / ORAL		166 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	DROPS / ORAL	NA		Exact identifier — unii candidate 49 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	PASTE, DENTIFRICE / DENTAL	1.4 %w/w		Exact identifier — unii candidate 42 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	CAPSULE, COATED PELLETS / ORAL		456 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	PASTILLE / ORAL	NA		Exact identifier — unii candidate 22 equally ranked IID candidates
CROSCARMELLOSE SODIUM	CROSCARMELLOSE SODIUM	M28OL1HH48	TABLET, COATED / ORAL		224 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
FD&C YELLOW NO. 6	FD&C YELLOW NO. 6	H77VEI93A8	SUSPENSION, EXTENDED RELEASE / ORAL	0.12 mg/5ml		Exact identifier — unii candidate 34 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	CAPSULE / ORAL		5785 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	INJECTION / INTRAMUSCULAR	203.5 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
SODIUM BICARBONATE	SODIUM BICARBONATE	8MDF5V39QO	GRANULE, EFFERVESCENT / ORAL	267 mg		Exact identifier — unii candidate 34 equally ranked IID candidates
SODIUM BICARBONATE	SODIUM BICARBONATE	8MDF5V39QO	TABLET, EXTENDED RELEASE / ORAL		81 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	POWDER / RESPIRATORY (INHALATION)	NA		Exact identifier — unii candidate 49 equally ranked IID candidates
FD&C YELLOW NO. 6	FD&C YELLOW NO. 6	H77VEI93A8	TABLET, DELAYED RELEASE / ORAL		2 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
SODIUM BICARBONATE	SODIUM BICARBONATE	8MDF5V39QO	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL		6 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
SODIUM BICARBONATE	SODIUM BICARBONATE	8MDF5V39QO	TABLET / BUCCAL		42 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	OINTMENT / TOPICAL	5 %w/w		Exact identifier — unii candidate 40 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	GEL / DENTAL	1.47 %w/w		Exact identifier — unii candidate 42 equally ranked IID candidates
TRIETHYL CITRATE	TRIETHYL CITRATE	8Z96QXD6UM	CAPSULE / ORAL		10 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	TABLET, FILM COATED / ORAL	590 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
D&C YELLOW NO. 10	D&C YELLOW NO. 10	35SW5USQ3G	ELIXIR / ORAL	0.3 mg/15ml		Exact identifier — unii candidate 31 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, ORALLY DISINTEGRATING / ORAL		6 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
CROSCARMELLOSE SODIUM	CROSCARMELLOSE SODIUM	M28OL1HH48	CAPSULE, COATED PELLETS / ORAL		198 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
FD&C YELLOW NO. 6	FD&C YELLOW NO. 6	H77VEI93A8	LIQUID / ORAL	0.2 mg/1ml		Exact identifier — unii candidate 34 equally ranked IID candidates
SODIUM BICARBONATE	SODIUM BICARBONATE	8MDF5V39QO	GUM, CHEWING / ORAL		360 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	CAPSULE / ORAL	530 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL		1576 mg	Exact identifier — unii candidate 28 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
b9d65b82-feed-4b85-9691-6cb0f75f8de7			7227aef1-e351-4dde-baae-2123e48c35e3	2025-05-13	Warnings	Exact identifier spl set id: 7227aef1-e351-4dde-baae-2123e48c35e3

Reported adverse events (FAERS/openFDA)#

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