FDA.reportPublic FDA data

healthy accents aspirin

Manufacturer
DZA Brands LLC
Effective date
2018-12-18
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-02 00:40:45

Label at a glance#

Producthealthy accents aspirin
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 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)

Label contents#

Full prescribing information#

Active ingredient (in each 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:

  1. hives
  2. facial swelling
  3. asthma (wheezing)
  4. shock

Stomach bleeding warning:  This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you

  1. are age 60 or older
  2. have had stomach ulcers or bleeding problems
  3. take a blood thinning (anticoagulant) or steroid drug
  4. take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
  5. have 3 or more alcoholic drinks every day while using this product
  6. take more or for a longer time than directed

Do not use

OTC - DO NOT USE SECTION

  1. if you have ever had an allergic reaction to any other pain reliever/fever reducer
  2. 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

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

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

taking a prescription drug for diabetes, gout or arthritis

Stop use and ask a doctor if

OTC - STOP USE SECTION

  1. an allergic reaction occurs. Seek medical help right away.
  2. you experience any of the following signs of stomach bleeding:
  3. feel faint
  4. vomit blood
  5. have bloody or black stools
  6. have stomach pain that does not get better
  7. pain gets worse or lasts for more than 10 days
  8. fever gets worse or lasts for more than 3 days
  9. redness or swelling is present
  10. new symptoms occur
  11. ringing in the ears or a 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 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.

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

  1. drink a full glass of water with each dose
  2. 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
  3. children under 12 years: consult a doctor

Other information

STORAGE AND HANDLING SECTION

  1. store at 20°-25°C (68°-77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

corn starch, D&C red #27 aluminum lake, dextrose excipient, FD&C red #40 aluminum lake, flavors, saccharin sodium

Questions or comments?

OTC - QUESTIONS SECTION

1-866-322-2439

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Compare to Bayer® Chewable Aspirin active ingredient

low dose

aspirin

pain reliever (NSAID) - 81 mg

low dose - aspirin regimen

cherry flavor

actual size

81 mg each

Aspirin Carton Image 1
Aspirin Carton Image 1
Aspirin Carton Image 1
Aspirin Carton Image 1

Aspirin Carton Image 2

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ASPIRINACTIVE INGREDIENTR16CO5Y76E2
ASPIRINACTIVE MOIETYR16CO5Y76E2
SACCHARIN SODIUM DIHYDRATEINACTIVE INGREDIENTSB8ZUX40TY2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJ2

Products#

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

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

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55316-27455316-274-68

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
ASPIRINR16CO5Y76EACTIB
SACCHARIN SODIUMSB8ZUX40TYIACT
STARCH, CORNO8232NY3SJIACT

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 · 56 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
SACCHARIN SODIUM DIHYDRATESACCHARIN SODIUMSB8ZUX40TYOINTMENT / DENTALNAExact identifier — unii candidate
34 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJCAPSULE, DELAYED RELEASE / ORAL216 mgExact identifier — unii candidate
22 equally ranked IID candidates
SACCHARIN SODIUM DIHYDRATESACCHARIN SODIUMSB8ZUX40TYPASTE / ORAL3 mgExact identifier — unii candidate
34 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJTABLET / ORAL1116 mgExact identifier — unii candidate
22 equally ranked IID candidates
SACCHARIN SODIUM DIHYDRATESACCHARIN SODIUMSB8ZUX40TYGRANULE, FOR SOLUTION / ORAL5.5 mg/120mlExact identifier — unii candidate
34 equally ranked IID candidates
SACCHARIN SODIUM DIHYDRATESACCHARIN SODIUMSB8ZUX40TYTABLET / ORAL43 mgExact identifier — unii candidate
34 equally ranked IID candidates
SACCHARIN SODIUM DIHYDRATESACCHARIN SODIUMSB8ZUX40TYINJECTION / INTRAMUSCULAR22 mgExact identifier — unii candidate
34 equally ranked IID candidates
SACCHARIN SODIUM DIHYDRATESACCHARIN SODIUMSB8ZUX40TYSOLUTION / RESPIRATORY (INHALATION)NAExact identifier — unii candidate
34 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJTABLET, EXTENDED RELEASE / ORAL184 mgExact identifier — unii candidate
22 equally ranked IID candidates
SACCHARIN SODIUM DIHYDRATESACCHARIN SODIUMSB8ZUX40TYSOLUTION / ORAL665 mgExact identifier — unii candidate
34 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJCAPSULE / ORAL5785 mgExact identifier — unii candidate
22 equally ranked IID candidates
SACCHARIN SODIUM DIHYDRATESACCHARIN SODIUMSB8ZUX40TYSYRUP / ORAL24 mgExact identifier — unii candidate
34 equally ranked IID candidates
SACCHARIN SODIUM DIHYDRATESACCHARIN SODIUMSB8ZUX40TYSUSPENSION / ORAL5000 mg/5mlExact identifier — unii candidate
34 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJDROPS / ORALNAExact identifier — unii candidate
22 equally ranked IID candidates
SACCHARIN SODIUM DIHYDRATESACCHARIN SODIUMSB8ZUX40TYTABLET, FOR SUSPENSION / ORAL6 mgExact identifier — unii candidate
34 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJCAPSULE, EXTENDED RELEASE / ORAL194 mgExact identifier — unii candidate
22 equally ranked IID candidates
SACCHARIN SODIUM DIHYDRATESACCHARIN SODIUMSB8ZUX40TYSOLUTION / RECTAL665 mgExact identifier — unii candidate
34 equally ranked IID candidates
SACCHARIN SODIUM DIHYDRATESACCHARIN SODIUMSB8ZUX40TYTABLET / BUCCAL0.4 mgExact identifier — unii candidate
34 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJSUSPENSION, EXTENDED RELEASE / ORAL113 mgExact identifier — unii candidate
22 equally ranked IID candidates
SACCHARIN SODIUM DIHYDRATESACCHARIN SODIUMSB8ZUX40TYSUSPENSION / RECTAL290 mgExact identifier — unii candidate
34 equally ranked IID candidates
SACCHARIN SODIUM DIHYDRATESACCHARIN SODIUMSB8ZUX40TYTABLET, FILM COATED / ORAL2 mgExact identifier — unii candidate
34 equally ranked IID candidates
SACCHARIN SODIUM DIHYDRATESACCHARIN SODIUMSB8ZUX40TYLIQUID / ORAL3 mgExact identifier — unii candidate
34 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJTABLET, CHEWABLE / ORAL180 mgExact identifier — unii candidate
22 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJTABLET, COATED / ORAL256 mgExact identifier — unii candidate
22 equally ranked IID candidates
SACCHARIN SODIUM DIHYDRATESACCHARIN SODIUMSB8ZUX40TYTABLET / RECTAL0.6 mgExact identifier — unii candidate
34 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJCONCENTRATE / ORALNAExact identifier — unii candidate
22 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJTABLET, DELAYED RELEASE / ORAL713 mgExact identifier — unii candidate
22 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJSUSPENSION/ DROPS / ORAL90 mgExact identifier — unii candidate
22 equally ranked IID candidates
SACCHARIN SODIUM DIHYDRATESACCHARIN SODIUMSB8ZUX40TYGEL / DENTAL0.3 %w/wExact identifier — unii candidate
34 equally ranked IID candidates
SACCHARIN SODIUM DIHYDRATESACCHARIN SODIUMSB8ZUX40TYELIXIR / ORAL15 mg/5mlExact identifier — unii candidate
34 equally ranked IID candidates
SACCHARIN SODIUM DIHYDRATESACCHARIN SODIUMSB8ZUX40TYTABLET, ORALLY DISINTEGRATING / ORAL10 mgExact identifier — unii candidate
34 equally ranked IID candidates
SACCHARIN SODIUM DIHYDRATESACCHARIN SODIUMSB8ZUX40TYTABLET, CHEWABLE / ORAL84 mgExact identifier — unii candidate
34 equally ranked IID candidates
SACCHARIN SODIUM DIHYDRATESACCHARIN SODIUMSB8ZUX40TYINJECTION / INTRAVENOUS22 mgExact identifier — unii candidate
34 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJSUSPENSION / ORAL900 mgExact identifier — unii candidate
22 equally ranked IID candidates
SACCHARIN SODIUM DIHYDRATESACCHARIN SODIUMSB8ZUX40TYCAPSULE / ORAL24 mgExact identifier — unii candidate
34 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJPOWDER, FOR SUSPENSION / ORAL34 mgExact identifier — unii candidate
22 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJCAPSULE, COATED, EXTENDED RELEASE / ORAL19 mgExact identifier — unii candidate
22 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJTABLET, FILM COATED / ORAL2000 mgExact identifier — unii candidate
22 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJTABLET, ORALLY DISINTEGRATING / ORAL100 mgExact identifier — unii candidate
22 equally ranked IID candidates
SACCHARIN SODIUM DIHYDRATESACCHARIN SODIUMSB8ZUX40TYSOLUTION / DENTAL0.05 %w/vExact identifier — unii candidate
34 equally ranked IID candidates
SACCHARIN SODIUM DIHYDRATESACCHARIN SODIUMSB8ZUX40TYFILM / BUCCAL3 mgExact identifier — unii candidate
34 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJPASTILLE / ORALNAExact identifier — unii candidate
22 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJTABLET / SUBLINGUAL409 mgExact identifier — unii candidate
22 equally ranked IID candidates
SACCHARIN SODIUM DIHYDRATESACCHARIN SODIUMSB8ZUX40TYTABLET / SUBLINGUAL7 mgExact identifier — unii candidate
34 equally ranked IID candidates
SACCHARIN SODIUM DIHYDRATESACCHARIN SODIUMSB8ZUX40TYPOWDER, FOR SUSPENSION / ORAL85 mgExact identifier — unii candidate
34 equally ranked IID candidates
SACCHARIN SODIUM DIHYDRATESACCHARIN SODIUMSB8ZUX40TYFILM, SOLUBLE / BUCCAL2 mgExact identifier — unii candidate
34 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL21 mgExact identifier — unii candidate
22 equally ranked IID candidates
SACCHARIN SODIUM DIHYDRATESACCHARIN SODIUMSB8ZUX40TYAEROSOL, METERED / RESPIRATORY (INHALATION)0.05 %w/wExact identifier — unii candidate
34 equally ranked IID candidates
SACCHARIN SODIUM DIHYDRATESACCHARIN SODIUMSB8ZUX40TYPOWDER, FOR SOLUTION / ORAL199 mgExact identifier — unii candidate
34 equally ranked IID candidates
SACCHARIN SODIUM DIHYDRATESACCHARIN SODIUMSB8ZUX40TYWAFER / ORAL8 mgExact identifier — unii candidate
34 equally ranked IID candidates
SACCHARIN SODIUM DIHYDRATESACCHARIN SODIUMSB8ZUX40TYOINTMENT / TOPICALNAExact identifier — unii candidate
34 equally ranked IID candidates
SACCHARIN SODIUM DIHYDRATESACCHARIN SODIUMSB8ZUX40TYCONCENTRATE / ORAL6 mgExact identifier — unii candidate
34 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJTABLET / BUCCAL16.6 mgExact identifier — unii candidate
22 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJINSERT / VAGINAL147 mgExact identifier — unii candidate
22 equally ranked IID candidates
SACCHARIN SODIUM DIHYDRATESACCHARIN SODIUMSB8ZUX40TYPASTE, DENTIFRICE / DENTAL0.2 %w/wExact identifier — unii candidate
34 equally ranked IID candidates
SACCHARIN SODIUM DIHYDRATESACCHARIN SODIUMSB8ZUX40TYPASTE / DENTAL0.3 %w/wExact identifier — unii candidate
34 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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
edff51b9-7d7a-4c05-9489-6702db543ff61daa41da-b84c-47bf-81a8-9fee105e712a2018-12-18WarningsExact identifier
spl id: edff51b9-7d7a-4c05-9489-6702db543ff6
spl set id: 1daa41da-b84c-47bf-81a8-9fee105e712a

Reported adverse events (FAERS/openFDA)#

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