aspirin

Manufacturer: Major Pharmaceuticals
Effective date: 2024-08-23
Label type: HUMAN OTC DRUG LABEL
Version: 6
Source: full-release
Hydrated at: 2026-06-01 00:19:34

Label at a glance#

Productaspirin

Active ingredientASPIRIN

Label structure9 sections

Indications and uses

for the temporary relief of minor aches and pains

Dosage and administration

• drink a full glass of water with each dose • adults and children 12 years and over: take 4 to 8 chewable 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 20-25°C (68-77°F)

Contacts and useful links#

PhonePoison Help1-800-222-1222

PhoneLabel contact1-800-719-9260

Label contents#

Full prescribing information#

Active ingredient (in each chewable tablet)

OTC - ACTIVE INGREDIENT SECTION

Aspirin 81 mg (NSAID*)

*nonsteroidal anti-inflammatory drug

Purpose

OTC - PURPOSE SECTION

Pain reliever

Uses

INDICATIONS & USAGE SECTION

for the temporary relief of minor aches and pains

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
facial swelling
asthma (wheezing)
shock

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 have ever had an allergic reaction to any other pain reliever/fever reducer
for at least 7 days after tonsillectomy or oral surgery unless directed by a doctor

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
- vomit blood
- have bloody or black stools
- have stomach pain that does not get better
pain gets worse or lasts for more than 10 days
fever gets worse or lasts for more than 3 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 at 20 weeks or later in 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 (1-800-222-1222).

Directions

DOSAGE & ADMINISTRATION SECTION

drink a full glass of water with each dose
adults and children 12 years and over: take 4 to 8 chewable 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 20-25°C (68-77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

corn starch, dextrose excipient, FD&C yellow no. 6 aluminum lake, flavors, saccharin sodium

Questions or comments?

OTC - QUESTIONS SECTION

1-800-719-9260

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MAJOR^®

Compare to the active ingredient in Bayer^® Chewable Low Dose Aspirin

Chewable

Aspirin

81 mg

Actual Size

Pain Reliever (NSAID)

Low Dose Aspirin Regimen

Talk to your doctor or other healthcare provider before using this product for your heart.

SEE NEW WARNING INFORMATION

Orange Flavor

36 Tablets

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
318272	aspirin 81 MG Chewable Tablet	PSN	6
318272	aspirin 81 MG Chewable Tablet	SCD	6
318272	ASA 81 MG Chewable Tablet	SY	6

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
ASPIRIN Pharmacologic Class Indexing	3	Indexing - Pharmacologic Class	20191108

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
d7724692-1155-4cc8-a415-22f5fc4aec35	Product name	6	20220216
bde672ba-4805-28d0-1986-73543d41b412	Product name	2	20210201
f212291f-05fe-9603-fc7e-bd73e38ce1e6	Product name	2	20161129
ade821ba-260a-47e2-bd89-743e27ac9906	Product name	1	20161121
182f9ab4-4ab5-c449-200f-87ce2ce8e550	Product name	2	20151105
9425d234-4ae1-4b53-adc6-8cc7af6dd657	Product name	1	20150929
2a21311a-89e2-0e83-2ebd-117f9798b2b2	Product name	1	20140508
9007e8a7-ff50-f9b9-7945-f2a1deadd94e	Product name	1	20140508
96c2be53-8e44-452d-56a2-d255b2f1af2d	Product name	1	20140508
bf8bd5f7-495f-4022-2780-7ded7ea7ea44	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0904-4040-73	aspirin	1 in 1 CARTON	TABLET, CHEWABLE	1		6
0904-4040-73	aspirin	36 in 1 BOTTLE	TABLET, CHEWABLE	36		6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0904-4040	ASPIRIN TABLET, CHEWABLE [MAJOR PHARMACEUTICALS]	6	Current NDC, Legacy NDC, 2 package rows	20240915_58684138-04d1-44a4-bc52-c5b85d93d7a6.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0904-4040-73	EA - Each	0904-4040	bb5cc8ec-5b24-4182-ad88-2e3f62517679	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
ASPIRIN	ACTIVE INGREDIENT	R16CO5Y76E	3
ASPIRIN	ACTIVE MOIETY	R16CO5Y76E	3
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	3
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	3
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	3

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

aspirin
STARCH, CORN
FD&C YELLOW NO. 6 ALUMINUM LAKE
SACCHARIN SODIUM

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
0904-4040	0904-4040-73

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
ASPIRIN	R16CO5Y76E	ACTIB
STARCH, CORN	O8232NY3SJ	IACT
FD&C YELLOW NO. 6 ALUMINUM LAKE	GYP6Z2JR6Q	IACT
SACCHARIN SODIUM	SB8ZUX40TY	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 1 · 6 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
FD&C YELLOW NO. 6	FD&C YELLOW NO. 6	H77VEI93A8	TABLET, CHEWABLE / ORAL	0.41 mg		Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
FD&C YELLOW NO. 6	FD&C YELLOW NO. 6	H77VEI93A8	TABLET, CHEWABLE / ORAL	0.41 mg		Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	TABLET, CHEWABLE / ORAL		180 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	TABLET, CHEWABLE / ORAL		84 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	TABLET, CHEWABLE / ORAL		84 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	TABLET, CHEWABLE / ORAL		180 mg	Exact identifier — unii+route+dosage form 2 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
aspirin	ASPIRIN	Major Pharmaceuticals	58684138-04d1-44a4-bc52-c5b85d93d7a6	2024-08-23	Warnings	Exact identifier ndc (package): 0904-4040-73 ndc (product): 0904-4040 ndc11 (package): 00904404073 spl id: 6df8fec2-6cf9-4c90-98b5-3d53901f21d6 spl set id: 58684138-04d1-44a4-bc52-c5b85d93d7a6

Reported adverse events (FAERS/openFDA)#

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