Aspirin Chewable

Manufacturer: NCS HealthCare of KY, Inc dba Vangard Labs
Effective date: 2013-02-27
Label type: HUMAN OTC DRUG LABEL
Version: 6
Source: legacy-cache
Hydrated at: 2026-08-02 01:41:24

Label at a glance#

ProductAspirin Chewable

Active ingredientASPIRIN

Label structure9 sections

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: ask a doctor.

Storage and handling

Store a 20 - 25 degrees C (68 - 77 degrees F)

Contacts and useful links#

PhonePoison Help1-800-222-1222

PhoneLabel contact1-800-616-2471

Label contents#

Full prescribing information#

Active ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Aspirin 81mg (NSAID)*

*nonsteriodal anti-inflammatory drug

Purpose

OTC - PURPOSE SECTION

Pain Reliever

Use(s)

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 are rare but serious illness.

Allergy alert: Aspirin may cause a severe allergic reaction which may include: facial swelling, hives, 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

You have high blood pressure, heart disease, liver cirrhosis, or kidney disease, stomach bleeding warning applies to you , you have a history of stomach problems, such as heartburn, you are taking a diuretic, you have asthma.

Ask a doctor or pharmacist before use if

OTC - ASK DOCTOR/PHARMACIST SECTION

If you are taking a prescription drug for diabetes, gout or arthritis.

Stop use and ask a doctor if

OTC - STOP USE SECTION

an allergic reaction occurs. Seek medical help right away. If 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, redness or swelling is present, new symproms appear, ringing in the ears or a loss of hearing occurs. These could be signs of a serious condition.

Pregnancy/Breastfeeding

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 prignancy 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

Keep out of reach of children. 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 tablets every 4 hours not to exceed 48 tablets in 24 hours unless directed by a doctor.

Children under 12 years: ask a doctor.

Storage

STORAGE AND HANDLING SECTION

Store a 20 - 25 degrees C (68 - 77 degrees F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions

OTC - QUESTIONS SECTION

Questions or Comments? 1-800-616-2471

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Aspirin 81mg Chewable Tablets

Principal Display Panel-Aspirin (NSAID*) chewable Tabs 81mg *nonsteroidal anti-inflammatory drug

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
0615-3508-31	2022-11-02	C162847	48780-1	9d75b9d0-2f4d-f424-e053-dadaa90a57ce	Aspirin Chewable 81mg
0615-3508-39	2022-11-02	C162847	48780-1	9d75b9d0-2f4d-f424-e053-dadaa90a57ce	Aspirin Chewable 81mg
0615-3508-31	2020-01-31	C162847	48780-1	9d75b9d0-2f4d-f424-e053-dadaa90a57ce	Aspirin Chewable 81mg
0615-3508-39	2020-01-31	C162847	48780-1	9d75b9d0-2f4d-f424-e053-dadaa90a57ce	Aspirin Chewable 81mg

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	6
ASPIRIN	ACTIVE MOIETY	R16CO5Y76E	6
DEXTROSE	INACTIVE INGREDIENT	IY9XDZ35W2	6
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	6
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	6
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	6

Products#

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

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

Aspirin Chewable
ASPIRIN
DEXTROSE
FD&C YELLOW NO. 6
SACCHARIN SODIUM
STARCH, CORN

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
0615-3508	0615-3508-31, 0615-3508-39
0904-4040

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
ASPIRIN	R16CO5Y76E	ACTIB
DEXTROSE	IY9XDZ35W2	IACT
FD&C YELLOW NO. 6	H77VEI93A8	IACT
SACCHARIN SODIUM	SB8ZUX40TY	IACT
STARCH, CORN	O8232NY3SJ	IACT

Source Document#

Source XML · Source PDF

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 · 4 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
DEXTROSE	DEXTROSE	IY9XDZ35W2	TABLET, CHEWABLE / ORAL		1286 mg	Exact identifier — unii+route+dosage form
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	TABLET, CHEWABLE / ORAL		84 mg	Exact identifier — unii+route+dosage form
STARCH, CORN	STARCH, CORN	O8232NY3SJ	TABLET, CHEWABLE / ORAL		180 mg	Exact identifier — unii+route+dosage form

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 · 2 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 (product): 0904-4040
58569e24-e998-4a58-9a45-c71197a7db53			0cb8bbbf-c367-4547-80d5-013023f0d5ca	2021-03-08	Warnings	Exact identifier spl set id: 0cb8bbbf-c367-4547-80d5-013023f0d5ca

Reported adverse events (FAERS/openFDA)#

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