Bayer ® Advanced Aspirin 325 mg Coated Tablet

Manufacturer: Physicians Total Care, Inc.
Effective date: 2014-04-23
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: full-release
Hydrated at: 2026-05-31 22:39:04

Label at a glance#

ProductAspirin

Active ingredientAspirin

Label structure10 sections

Indications and uses

temporarily relieves headache menstrual pain minor pain of arthritis muscle pain pain and fever of colds toothache

Dosage and administration

drink a full glass of water with each dose adults and children 12 years and over: take 1 or 2 tablets every 4 hours or 3 tablets every 6 hours, not to exceed 12 tablets in 24 hours children under 12 years: consult a doctor

Storage and handling

each tablet contains: sodium 47 mg store at room temperature. Avoid excessive heat and moisture. Keep desiccant and product in original bottle. Immediately close cap tightly after use. save carton for full directions and warnings

Contacts and useful links#

PhoneLabel contact1-800-331-4536

Websitewww.bayeraspirin.com

www.bayeraspirin.com

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Aspirin 325 mg (NSAID)¹

1 nonsteroidal anti-inflammatory drug

Purposes

OTC - PURPOSE SECTION

Pain reliever/fever reducer

Uses

INDICATIONS & USAGE SECTION

temporarily relieves

headache
menstrual pain
minor pain of arthritis
muscle pain
pain and fever of colds
toothache

Warnings

WARNINGS SECTION

Reye's syndrome

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

Aspirin may cause a severe allergic reaction which may include:

hives
facial swelling
asthma (wheezing)
shock

Stomach bleeding warning

SPL UNCLASSIFIED SECTION

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

OTC - DO NOT USE SECTION

Do not use if you are allergic to aspirin or any other pain reliever/fever reducer

OTC - ASK DOCTOR SECTION

Ask a doctor before use if

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
you have a sodium-restricted diet

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are taking a prescription drug for

gout
diabetes
arthritis

OTC - STOP USE SECTION

Stop use and ask a doctor if

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 more than 10 days
redness or swelling is present
fever lasts more than 3 days
new symptoms occur
ringing in the ears or a loss of hearing occurs

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, 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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

drink a full glass of water with each dose
adults and children 12 years and over: take 1 or 2 tablets every 4 hours or 3 tablets every 6 hours, not to exceed 12 tablets in 24 hours
children under 12 years: consult a doctor

Other information

STORAGE AND HANDLING SECTION

each tablet contains: sodium 47 mg
store at room temperature. Avoid excessive heat and moisture. Keep desiccant and product in original bottle. Immediately close cap tightly after use.
save carton for full directions and warnings

Inactive ingredients

INACTIVE INGREDIENT SECTION

carnauba wax, colloidal silicon dioxide, hypromellose, sodium carbonate, zinc stearate

Questions or comments?

OTC - QUESTIONS SECTION

1-800-331-4536 (Mon – Fri 9AM – 5PM EST) or www.bayeraspirin.com

PRINCIPAL DISPLAY PANEL - 325 mg Tablet

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SEE NEW WARNINGS INFORMATION

NEW!

carton

ASPIRIN (NSAID) PAIN RELIEVER/FEVER REDUCER

REGULAR
STRENGTH

325 mg

FAST, SAFE PAIN RELIEF

PRINCIPAL DISPLAY PANEL - 325 mg Tablet

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
212033	aspirin 325 MG Oral Tablet	PSN	2
212033	aspirin 325 MG Oral Tablet	SCD	2
212033	ASA 325 MG Oral Tablet	SY	2

DailyMed Pharmacologic Classes#

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

Product Linked Resources#

Resource, Code type, Value table
Resource	Code type	Value	Equivalent identifiers	Source image
Data code	Code 128	11981000000		1198.jpg

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
54868-1198-0	2019-09-24	C162847	48780-1	9350213a-4085-c013-e053-90daa90a1393	Bayer ® Advanced Aspirin 325 mg Coated Tablet

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
54868-1198-0	Aspirin	100 in 1 BOTTLE	TABLET	100		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
54868-1198	ASPIRIN TABLET [PHYSICIANS TOTAL CARE, INC.]	2	1 package rows	20140423_84ce59f0-5cb4-4ba4-81f3-020676deb31e.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
54868-1198-0	EA - Each	54868-1198	81db8df2-16ef-4b19-81ad-4c245c0b424a	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Aspirin	ACTIVE INGREDIENT	R16CO5Y76E	2
Aspirin	ACTIVE MOIETY	R16CO5Y76E	2
Carnauba Wax	INACTIVE INGREDIENT	R12CBM0EIZ	2
Hypromelloses	INACTIVE INGREDIENT	3NXW29V3WO	2
Silicon Dioxide	INACTIVE INGREDIENT	ETJ7Z6XBU4	2
Sodium carbonate	INACTIVE INGREDIENT	45P3261C7T	2
Zinc stearate	INACTIVE INGREDIENT	H92E6QA4FV	2

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

Aspirin
Carnauba Wax
Silicon Dioxide
Hypromelloses
Sodium carbonate
Zinc stearate

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
54868-1198	54868-1198-0
0280-2605

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
Aspirin	R16CO5Y76E	ACTIB
Carnauba Wax	R12CBM0EIZ	IACT
Silicon Dioxide	ETJ7Z6XBU4	IACT
Hypromelloses	3NXW29V3WO	IACT
Sodium carbonate	45P3261C7T	IACT
Zinc stearate	H92E6QA4FV	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 3 · 127 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
Sodium carbonate	SODIUM CARBONATE	45P3261C7T	LOZENGE / ORAL		500 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
Hypromelloses	HYPROMELLOSE	3NXW29V3WO	TABLET / ORAL		1127 mg	Exact identifier — unii candidate 27 equally ranked IID candidates
Silicon Dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	GRANULE / ORAL	5000 mg		Exact identifier — unii candidate 49 equally ranked IID candidates
Hypromelloses	HYPROMELLOSE	3NXW29V3WO	CAPSULE / ORAL		1488 mg	Exact identifier — unii candidate 27 equally ranked IID candidates
Hypromelloses	HYPROMELLOSE	3NXW29V3WO	SYRUP / ORAL		250 mg	Exact identifier — unii candidate 27 equally ranked IID candidates
Sodium carbonate	SODIUM CARBONATE	45P3261C7T	INJECTION, SOLUTION / INTRAVENOUS	ADJ PH		Exact identifier — unii candidate 28 equally ranked IID candidates
Silicon Dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	SOLUTION / ORAL		336 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
Silicon Dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		336 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
Zinc stearate	ZINC STEARATE	H92E6QA4FV	OINTMENT / TOPICAL	NA		Exact identifier — unii candidate 12 equally ranked IID candidates
Silicon Dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	POWDER, FOR SOLUTION / ORAL		280 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
Hypromelloses	HYPROMELLOSE	3NXW29V3WO	GEL / RECTAL		348 mg	Exact identifier — unii candidate 27 equally ranked IID candidates
Silicon Dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	CAPSULE, EXTENDED RELEASE / ORAL		168 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
Hypromelloses	HYPROMELLOSE	3NXW29V3WO	CAPSULE, COATED PELLETS / ORAL	3.32 mg		Exact identifier — unii candidate 27 equally ranked IID candidates
Sodium carbonate	SODIUM CARBONATE	45P3261C7T	INJECTION / INTRAMUSCULAR	32.4 mg		Exact identifier — unii candidate 28 equally ranked IID candidates
Carnauba Wax	CARNAUBA WAX	R12CBM0EIZ	OINTMENT / TOPICAL	NA		Exact identifier — unii candidate 11 equally ranked IID candidates
Hypromelloses	HYPROMELLOSE	3NXW29V3WO	CREAM / TOPICAL	0.1 %w/w		Exact identifier — unii candidate 27 equally ranked IID candidates
Zinc stearate	ZINC STEARATE	H92E6QA4FV	TABLET, COATED / ORAL	1.82 mg		Exact identifier — unii candidate 12 equally ranked IID candidates
Silicon Dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	GEL / TOPICAL		6 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
Hypromelloses	HYPROMELLOSE	3NXW29V3WO	GRANULE / ORAL		45 mg	Exact identifier — unii candidate 27 equally ranked IID candidates
Hypromelloses	HYPROMELLOSE	3NXW29V3WO	TABLET, EXTENDED RELEASE / ORAL		1472 mg	Exact identifier — unii candidate 27 equally ranked IID candidates
Silicon Dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	GRANULE, FOR SUSPENSION / ORAL		200 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
Hypromelloses	HYPROMELLOSE	3NXW29V3WO	SOLUTION / OPHTHALMIC	0.5 %w/v		Exact identifier — unii candidate 27 equally ranked IID candidates
Sodium carbonate	SODIUM CARBONATE	45P3261C7T	INJECTION, SOLUTION / INTRAVASCULAR	ADJ PH		Exact identifier — unii candidate 28 equally ranked IID candidates
Zinc stearate	ZINC STEARATE	H92E6QA4FV	TABLET / SUBLINGUAL	2.5 mg		Exact identifier — unii candidate 12 equally ranked IID candidates
Zinc stearate	ZINC STEARATE	H92E6QA4FV	SYRUP / ORAL	NA		Exact identifier — unii candidate 12 equally ranked IID candidates
Carnauba Wax	CARNAUBA WAX	R12CBM0EIZ	TABLET, DELAYED RELEASE / ORAL	230 mg		Exact identifier — unii candidate 11 equally ranked IID candidates
Hypromelloses	HYPROMELLOSE	3NXW29V3WO	TABLET, CHEWABLE / ORAL	11.8 mg		Exact identifier — unii candidate 27 equally ranked IID candidates
Silicon Dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	CAPSULE, LIQUID FILLED / ORAL		106 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
Sodium carbonate	SODIUM CARBONATE	45P3261C7T	GUM, CHEWING / BUCCAL		720 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
Carnauba Wax	CARNAUBA WAX	R12CBM0EIZ	TABLET, FILM COATED / ORAL		1 mg	Exact identifier — unii candidate 11 equally ranked IID candidates
Hypromelloses	HYPROMELLOSE	3NXW29V3WO	SHAMPOO / TOPICAL	3 %w/w		Exact identifier — unii candidate 27 equally ranked IID candidates
Hypromelloses	HYPROMELLOSE	3NXW29V3WO	SYSTEM / TOPICAL		54 mg	Exact identifier — unii candidate 27 equally ranked IID candidates
Sodium carbonate	SODIUM CARBONATE	45P3261C7T	TABLET / ORAL		100 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
Zinc stearate	ZINC STEARATE	H92E6QA4FV	POWDER / TOPICAL	0.1 mg/mg		Exact identifier — unii candidate 12 equally ranked IID candidates
Sodium carbonate	SODIUM CARBONATE	45P3261C7T	CAPSULE, EXTENDED RELEASE / ORAL	6 mg		Exact identifier — unii candidate 28 equally ranked IID candidates
Silicon Dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	GRANULE, FOR SOLUTION / ORAL	1.8 mg/120ml		Exact identifier — unii candidate 49 equally ranked IID candidates
Hypromelloses	HYPROMELLOSE	3NXW29V3WO	TABLET, FILM COATED, EXTENDED RELEASE / ORAL	221 mg		Exact identifier — unii candidate 27 equally ranked IID candidates
Silicon Dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	SYSTEM / TRANSDERMAL		35 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
Zinc stearate	ZINC STEARATE	H92E6QA4FV	CAPSULE / ORAL	2.04 mg		Exact identifier — unii candidate 12 equally ranked IID candidates
Hypromelloses	HYPROMELLOSE	3NXW29V3WO	INSERT / VAGINAL	54.21 mg		Exact identifier — unii candidate 27 equally ranked IID candidates
Silicon Dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	CREAM / VAGINAL		51 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
Silicon Dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	FILM, EXTENDED RELEASE / TRANSDERMAL	49 mg		Exact identifier — unii candidate 49 equally ranked IID candidates
Sodium carbonate	SODIUM CARBONATE	45P3261C7T	GRANULE, FOR SUSPENSION / ORAL		39 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
Silicon Dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	GEL / DENTAL	19 %w/w		Exact identifier — unii candidate 49 equally ranked IID candidates
Silicon Dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	TAMPON / VAGINAL	NA		Exact identifier — unii candidate 49 equally ranked IID candidates
Silicon Dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	GEL / NASAL		20 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
Silicon Dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	POWDER / ORAL		602 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
Silicon Dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	SUSPENSION, EXTENDED RELEASE / ORAL		70 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
Silicon Dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	CAPSULE / RESPIRATORY (INHALATION)	NA		Exact identifier — unii candidate 49 equally ranked IID candidates
Sodium carbonate	SODIUM CARBONATE	45P3261C7T	CAPSULE, DELAYED RELEASE / ORAL		90 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
Silicon Dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET / SUBLINGUAL		10 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
Sodium carbonate	SODIUM CARBONATE	45P3261C7T	TABLET / BUCCAL		20 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
Sodium carbonate	SODIUM CARBONATE	45P3261C7T	INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS		1248 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
Hypromelloses	HYPROMELLOSE	3NXW29V3WO	SUSPENSION / ORAL		305 mg	Exact identifier — unii candidate 27 equally ranked IID candidates
Silicon Dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, FOR SUSPENSION / ORAL		220 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
Zinc stearate	ZINC STEARATE	H92E6QA4FV	CREAM / TOPICAL	6 %w/w		Exact identifier — unii candidate 12 equally ranked IID candidates
Silicon Dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	SUPPOSITORY / RECTAL	14 mg		Exact identifier — unii candidate 49 equally ranked IID candidates
Hypromelloses	HYPROMELLOSE	3NXW29V3WO	CAPSULE, EXTENDED RELEASE / ORAL	119.7 mg		Exact identifier — unii candidate 27 equally ranked IID candidates
Carnauba Wax	CARNAUBA WAX	R12CBM0EIZ	TABLET, FILM COATED, EXTENDED RELEASE / ORAL	140 mg		Exact identifier — unii candidate 11 equally ranked IID candidates
Silicon Dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	CAPSULE, DELAYED RELEASE / ORAL		40 mg	Exact identifier — unii candidate 49 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
95947bb4-46bb-435d-bb1c-d646aa556fdb			84ce59f0-5cb4-4ba4-81f3-020676deb31e	2014-04-23	Warnings	Exact identifier spl id: 95947bb4-46bb-435d-bb1c-d646aa556fdb spl set id: 84ce59f0-5cb4-4ba4-81f3-020676deb31e

Reported adverse events (FAERS/openFDA)#

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