Aspirin

Manufacturer: CVS Pharmacy
Effective date: 2021-10-13
Label type: HUMAN OTC DRUG LABEL
Version: 5
Source: legacy-cache
Hydrated at: 2026-08-01 22:33:24

Label at a glance#

ProductAspirin Safety Coated

Active ingredientASPIRIN

Label structure10 sections

Indications and uses

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

Dosage and administration

adults and children 12 years of age and over: take 1 to 2 tablets every 4 hours, while symptoms persist drink a full glass of water with each dose do not take more than 12 tablets in 24 hours unless directed by a doctor children under 12 years of age: do not use

Contacts and useful links#

PhoneLabel contact1-877-753-3935

PhoneLabel contact1-800-SHOP CVS

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
- muscle pain
- toothache
- menstrual pain
- colds
- minor arthritis pain
or as recommended by a 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:

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

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

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 right away.

Directions

DOSAGE & ADMINISTRATION SECTION

adults and children 12 years of age and over: take 1 to 2 tablets every 4 hours, while symptoms persist
drink a full glass of water with each dose
do not take more than 12 tablets in 24 hours unless directed by a doctor
children under 12 years of age: do not use

Other information

OTHER SAFETY INFORMATION

store between 20-25ºC (68-77ºF)

Inactive ingredients

INACTIVE INGREDIENT SECTION

corn starch, croscarmellose sodium, D&C yellow #10 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, methacrylic acid copolymer, microcrystalline cellulose, mineral oil, polysorbate 80, simethicone, sodium hydroxide, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Compare to the active ingredient in Ecotrin®†

Coated Tablets

Regular Strength

Aspirin 325 mg

Pain reliever (NSAID)

Aspirin Regimen**

ENTERIC COATED TABLETS

†This product is not manufactured or distributed by Prestige Brands, Inc., distributor of Ecotrin®.

**Talk to your doctor before starting an aspirin regimen.

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

CVS.com®

1-800-SHOP CVS

Product Labeling

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
59779-137-01	EA - Each	59779-137	7ae48eb3-f65b-4570-b530-a3d50420eba2	1	2017-06-15
59779-137-05	EA - Each	59779-137	5df6f9db-7046-440e-bd0a-30d7052ab267	1	2017-09-11
59779-137-12	EA - Each	59779-137	d0648f49-569d-4542-9acc-178b30ffb948	1	2021-05-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
ASPIRIN	ACTIVE INGREDIENT	R16CO5Y76E	2
ASPIRIN	ACTIVE MOIETY	R16CO5Y76E	2
ALUMINUM OXIDE	INACTIVE INGREDIENT	LMI26O6933	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	2
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	2
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	2
DIMETHICONE	INACTIVE INGREDIENT	92RU3N3Y1O	2
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	2
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	2
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)	INACTIVE INGREDIENT	74G4R6TH13	2
MINERAL OIL	INACTIVE INGREDIENT	T5L8T28FGP	2
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	2
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	2
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	2
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	2
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	2

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

Aspirin Safety Coated
Aspirin
STARCH, CORN
CROSCARMELLOSE SODIUM
D&C YELLOW NO. 10
FD&C YELLOW NO. 6
HYPROMELLOSES
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)
CELLULOSE, MICROCRYSTALLINE
MINERAL OIL
POLYSORBATE 80
DIMETHICONE
SODIUM HYDROXIDE
SODIUM LAURYL SULFATE
TALC
TITANIUM DIOXIDE
TRIETHYL CITRATE
ALUMINUM OXIDE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
59779-137	59779-137-01, 59779-137-12, 59779-137-05

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
ASPIRIN	R16CO5Y76E	ACTIB
STARCH, CORN	O8232NY3SJ	IACT
CROSCARMELLOSE SODIUM	M28OL1HH48	IACT
D&C YELLOW NO. 10	35SW5USQ3G	IACT
FD&C YELLOW NO. 6	H77VEI93A8	IACT
HYPROMELLOSES	3NXW29V3WO	IACT
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)	74G4R6TH13	IACT
CELLULOSE, MICROCRYSTALLINE	OP1R32D61U	IACT
MINERAL OIL	T5L8T28FGP	IACT
POLYSORBATE 80	6OZP39ZG8H	IACT
DIMETHICONE	92RU3N3Y1O	IACT
SODIUM HYDROXIDE	55X04QC32I	IACT
SODIUM LAURYL SULFATE	368GB5141J	IACT
TALC	7SEV7J4R1U	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
TRIETHYL CITRATE	8Z96QXD6UM	IACT
ALUMINUM OXIDE	LMI26O6933	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 · 592 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	SUSPENSION / ORAL		206 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	SUSPENSION/ DROPS / ORAL		23 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
FD&C YELLOW NO. 6	FD&C YELLOW NO. 6	H77VEI93A8	CAPSULE, EXTENDED RELEASE / ORAL	4.59 mg		Exact identifier — unii candidate 34 equally ranked IID candidates
CROSCARMELLOSE SODIUM	CROSCARMELLOSE SODIUM	M28OL1HH48	TABLET, CHEWABLE / ORAL		216 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	LOTION / TOPICAL	0.1 %w/w		Exact identifier — unii candidate 27 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	CAPSULE, COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 27 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	SOLUTION / INTRA-ARTERIAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	GEL / RECTAL		348 mg	Exact identifier — unii candidate 27 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION / EPIDURAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	TABLET, FILM COATED / ORAL		8 mg	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
D&C YELLOW NO. 10	D&C YELLOW NO. 10	35SW5USQ3G	TABLET, FILM COATED / ORAL	120 mg		Exact identifier — unii candidate 31 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	SOLUTION/ DROPS / OPHTHALMIC	0.25 %w/v		Exact identifier — unii candidate 78 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	POWDER, FOR SOLUTION / ORAL		690 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	TABLET, CHEWABLE, EXTENDED RELEASE / ORAL		1 mg	Exact identifier — unii candidate 42 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	SUSPENSION/ DROPS / OPHTHALMIC		1 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL		21 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, FOR SUSPENSION / ORAL		20100 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	SOAP / TOPICAL	1 %w/w		Exact identifier — unii candidate 40 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION, SOLUTION / EPIDURAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION / INTRAPLEURAL	ADJ PH		Exact identifier — unii candidate 174 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 HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	CAPSULE, COATED / ORAL	0.08 mg		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	SOLUTION / INTRAVASCULAR	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
D&C YELLOW NO. 10	D&C YELLOW NO. 10	35SW5USQ3G	SUSPENSION / ORAL	20 mg/5ml		Exact identifier — unii candidate 31 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	TABLET / RECTAL	32.4 mg		Exact identifier — unii candidate 35 equally ranked IID candidates
D&C YELLOW NO. 10	D&C YELLOW NO. 10	35SW5USQ3G	CAPSULE, COATED PELLETS / ORAL	0.01 mg		Exact identifier — unii candidate 31 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION / INTRACARDIAC	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	SOLUTION, GEL FORMING, EXTENDED RELEASE / OPHTHALMIC	0.05 %w/w		Exact identifier — unii candidate 78 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	SOLUTION, CONCENTRATE / INTRAVENOUS	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	GEL / OPHTHALMIC		6 mg	Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	TABLET, ORALLY DISINTEGRATING / ORAL		16 mg	Exact identifier — unii candidate 42 equally ranked IID candidates
TRIETHYL CITRATE	TRIETHYL CITRATE	8Z96QXD6UM	CAPSULE, DELAYED RELEASE / ORAL		70 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	LOTION / TOPICAL		21 mg	Exact identifier — unii candidate 174 equally ranked IID candidates
TRIETHYL CITRATE	TRIETHYL CITRATE	8Z96QXD6UM	TABLET / ORAL		52 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	SUPPOSITORY / RECTAL	72.15 mg		Exact identifier — unii candidate 78 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION, SUSPENSION / INTRAMUSCULAR	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	POWDER / RESPIRATORY (INHALATION)	NA		Exact identifier — unii candidate 42 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	SUPPOSITORY / RECTAL	NA		Exact identifier — unii candidate 30 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION / SOFT TISSUE	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / PARENTERAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	FILM, EXTENDED RELEASE / TRANSDERMAL	0.85 mg		Exact identifier — unii candidate 174 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	SYSTEM / TRANSDERMAL	6.09 mg		Exact identifier — unii candidate 30 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	SOLUTION / TOPICAL		39 mg	Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION, SOLUTION / INTRAVENOUS		78 mg	Exact identifier — unii candidate 174 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	POWDER / ORAL	2 mg		Exact identifier — unii candidate 40 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	SUSPENSION/ DROPS / OPHTHALMIC		3 mg	Exact identifier — unii candidate 27 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	TABLET / BUCCAL	16.6 mg		Exact identifier — unii candidate 22 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	TABLET, COATED / ORAL	1.5 mg		Exact identifier — unii candidate 30 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		615 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	SHAMPOO, SUSPENSION / TOPICAL	40 %w/v		Exact identifier — unii candidate 42 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	GUM, CHEWING / BUCCAL		182 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	IMPLANT / INTRAVITREAL	1.66 mg		Exact identifier — unii candidate 28 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION / INTRAVENOUS		456 mg	Exact identifier — unii candidate 174 equally ranked IID candidates
D&C YELLOW NO. 10	D&C YELLOW NO. 10	35SW5USQ3G	SUPPOSITORY / RECTAL	0.11 mg		Exact identifier — unii candidate 31 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	CREAM, AUGMENTED / TOPICAL		6 mg	Exact identifier — unii candidate 174 equally ranked IID candidates
FD&C YELLOW NO. 6	FD&C YELLOW NO. 6	H77VEI93A8	SUSPENSION / ORAL		11 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	SOLUTION / INTRAPERITONEAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE, COATED / ORAL		17 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
CROSCARMELLOSE SODIUM	CROSCARMELLOSE SODIUM	M28OL1HH48	CAPSULE, DELAYED RELEASE / ORAL		72 mg	Exact identifier — unii candidate 22 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
3dc11402-4202-4697-915d-5bc2fec484b2			c19ad239-37bf-4eec-bef8-f66074b8a77d	2021-10-13	Warnings	Exact identifier spl id: 3dc11402-4202-4697-915d-5bc2fec484b2 spl set id: c19ad239-37bf-4eec-bef8-f66074b8a77d

Reported adverse events (FAERS/openFDA)#

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