ASPIRIN LOW DOSE CHEWABLE ORANGE PAIN RELIEVER

Manufacturer
HF Acquisition Co LLC, DBA HealthFirst
Effective date
2024-03-17
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:09:55

Label at a glance#

ProductASPIRIN LOW DOSE CHEWABLE ORANGE PAIN RELIEVER
Active ingredientASPIRIN
Label structure12 sections

Indications and uses

for the temporary relief of minor aches and pains or as recommended by your doctor ask your doctor about other uses for Chewable Aspirin 81 mg

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 exceed 48 tablets in 24 hours unless directed by a doctor children under 12 years consult a doctor

Label contents#

Full prescribing information#

ACTIVE INGREDIENT [IN EACH TABLET]

OTC - ACTIVE INGREDIENT SECTION

Aspirin 81mg (NSAID)* *nonsteroidal anti-inflammatory drug

OTC - PURPOSE SECTION

Pain reliever

USES

SPL UNCLASSIFIED SECTION

for the temporary relief of minor aches and pains or as recommended by your doctor
ask your doctor about other uses for Chewable Aspirin 81 mg

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

if you are allergic to aspirin or 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

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 have asthma
you are taking a diuretic

Ask a doctor or pharmacist before use if you are

taking a prescription drug for

gout
diabetes
arthritis

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

These could be signs of a serious condition

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.

Keep out of reach of children.

In case of accidental overdose, get medical help or contact a Poison Control Center right away.

DIRECTIONS

SPL UNCLASSIFIED 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 exceed 48 tablets in 24 hours unless directed by a doctor
children under 12 years consult a doctor

OTHER INFORMATION

SPL UNCLASSIFIED SECTION

store at room temperature (150-300C)
Tamper Evident: do not use if safety seal under cap is broken or missing

INACTIVE INGREDIENT SECTION

corn starch, dextrose monohydrate, FD&C yellow #6, orange flavor, silicon dioxide, sodium saccharine, stearic acid

OTC - QUESTIONS SECTION

1-800-616-2471

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 exceed 48 tablets in 24 hours unless directed by a doctor
children under 12 years consult a doctor

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN

INDICATIONS & USAGE SECTION

for the temporary relief of minor aches and pains or as recommneded by your doctor
ask your doctor about other uses for Chewable Aspirin 81 mg

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BOTTLE LABELBOTTLE LABEL

RFID LabelRFID Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
318272aspirin 81 MG Chewable TabletPSN1
318272aspirin 81 MG Chewable TabletSCD1
318272ASA 81 MG Chewable TabletSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ASPIRIN Pharmacologic Class Indexing3Indexing - Pharmacologic Class20191108

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
cb89b86a-369e-4204-8910-ae797c503af3Product name120230706
d7724692-1155-4cc8-a415-22f5fc4aec35Product name620220216
bde672ba-4805-28d0-1986-73543d41b412Product name220210201
d4880ace-a516-8c47-8dfd-73a4ba5887d7Product name220180830
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
f212291f-05fe-9603-fc7e-bd73e38ce1e6Product name220161129
ade821ba-260a-47e2-bd89-743e27ac9906Product name120161121
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
9425d234-4ae1-4b53-adc6-8cc7af6dd657Product name120150929
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
2a21311a-89e2-0e83-2ebd-117f9798b2b2Product name120140508
9007e8a7-ff50-f9b9-7945-f2a1deadd94eProduct name120140508
96c2be53-8e44-452d-56a2-d255b2f1af2dProduct name120140508
bf8bd5f7-495f-4022-2780-7ded7ea7ea44Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51662-1356-1ASPIRIN LOW DOSE CHEWABLE ORANGE PAIN RELIEVER90 in 1 BOTTLETABLET, CHEWABLE901

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51662-1356ASPIRIN LOW DOSE CHEWABLE ORANGE PAIN RELIEVER TABLET, CHEWABLE [HF ACQUISITION CO LLC, DBA HEALTHFIRST]1Current NDC, 1 package rows20240319_13e621dc-b2b4-98fd-e063-6394a90acc75.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-6794-30EA - Each0904-67940b6b3501-8a59-4d48-864f-25efe4b4475912023-04-07
0904-6794-80EA - Each0904-679478376407-1c58-42be-9458-6e0c6219806812018-11-06
0904-6794-89EA - Each0904-6794b50d3dc8-f0d6-49f7-ac05-baa38562ec1d12018-11-06

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
51662-135651662-1356-1
0904-6794

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Source Document#

Source XML

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Aspirin Low Dose Chewable OrangeASPIRINMAJOR PHARMACEUTICALSfb3a8e38-e991-49c9-93dc-1d29c0a97ba32026-03-05WarningsExact identifier
ndc (product): 0904-6794
ASPIRIN LOW DOSE CHEWABLE ORANGE PAIN RELIEVERASPIRIN LOW DOSE CHEWABLE ORANGE PAIN RELIEVERHF Acquisition Co LLC, DBA HealthFirst13e621dc-b2b4-98fd-e063-6394a90acc752024-03-17WarningsExact identifier
ndc (package): 51662-1356-1
ndc (product): 51662-1356
ndc11 (package): 51662135601
spl id: 13e621dc-b2b5-98fd-e063-6394a90acc75
spl set id: 13e621dc-b2b4-98fd-e063-6394a90acc75

Reported adverse events (FAERS/openFDA)#

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