FDA.reportPublic FDA data

Xpect Chewable Aspirin

Manufacturer
Cintas Corporation
Effective date
2025-09-25
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:14:53

Label at a glance#

ProductXpect Chewable Aspirin
Active ingredientASPIRIN
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each tablet)

Aspirin 81 mg (NSAID)*

*nonsteroidal anti-inflammatory drug 

OTC - PURPOSE SECTION

Purpose

Pain reliever

INDICATIONS & USAGE SECTION

Uses 

for the temporary relief of minor aches and pains or as recommended by your 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 
  • 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

OTC - DO NOT USE SECTION

Do not use

  • if you are allergic to aspirin or any other pain reliever/fever reducer 
  • this product for at least 7 days after tonsillectomy or oral surgery unless directed by a doctor 
  • if you have ever had an allergic reaction to this product or any of its ingredients

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

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 stool ■ 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

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 specifically 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 accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

DOSAGE & ADMINISTRATION SECTION

Directions

  • 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: consult a doctor

OTHER SAFETY INFORMATION

Other information

  • store at room temperature
  • do not use if packet is opened or torn

INACTIVE INGREDIENT SECTION

Inactive ingredients

corn starch, dextrates, FD&C yellow #6 aluminum lake, orange flavor, saccharin sodium

OTC - QUESTIONS SECTION

Questions or comments?

Call 1-877-973-2811 Monday – Friday 8 AM – 5 PM

Principal Display Panel - 25 Count Box

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Compare to the active ingredient in Bayer® Chewable Aspirin†

CHEWABLE ASPIRIN

Active Ingredient:

Aspirin 

Pain Reliever (NSAID)

Low Dose (81 mg)

Xpect® First aid

25 Tablets / 25 Packets (1 tablet in each packet) per Box

†This product is not manufactured or distributed by Bayer HealthCare LLC, owner of the registered trademark Bayer® Chewable Aspirin. 

25Box25Box

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
d7724692-1155-4cc8-a415-22f5fc4aec35Product name620220216
bde672ba-4805-28d0-1986-73543d41b412Product name220210201
f212291f-05fe-9603-fc7e-bd73e38ce1e6Product name220161129
ade821ba-260a-47e2-bd89-743e27ac9906Product name120161121
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
9425d234-4ae1-4b53-adc6-8cc7af6dd657Product name120150929
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
42961-258-01Xpect Chewable Aspirin25 in 1 BOXTABLET, CHEWABLE251
42961-258-01Xpect Chewable Aspirin1 in 1 PACKAGETABLET, CHEWABLE11

Products#

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

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

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
42961-25842961-258-01

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
NameUNIIKind
ASPIRINR16CO5Y76EACTIB
STARCH, CORNO8232NY3SJIACT
DEXTRATESG263MI44RUIACT
FD&C YELLOW NO. 6 ALUMINUM LAKEGYP6Z2JR6QIACT
SACCHARIN SODIUMSB8ZUX40TYIACT

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Xpect Chewable AspirinASPIRINCintas Corporationbddce374-1d35-4685-987d-4a4cc99941552025-09-25WarningsExact identifier
ndc (package): 42961-258-01
ndc (product): 42961-258
ndc11 (package): 42961025801
spl id: 8b1e363e-c166-460e-a3a5-17a79121bf54
spl set id: bddce374-1d35-4685-987d-4a4cc9994155

Reported adverse events (FAERS/openFDA)#

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