FDA.reportPublic FDA data

Aerotab Non-Aspirin Tablets

Manufacturer
Aero Healthcare
Effective date
2025-02-26
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:56:16

Label at a glance#

ProductAeroTab Non-Aspirin
Active ingredientACETAMINOPHEN
Label structure14 sections

Indications and uses

temporary relief of minor aches and pains associated with common cold headache toothache muscular aches backache arthritis menstrual cramps temporarily reduces fever

Dosage and administration

take only as directed - see Overdose warning do not take more than 8 tablets in any 24 hour period do not use more than 10 days unless directed to do so by a doctor Adults and children 12 years and over: take 2 tablets every 4 to 6 hours. Children under 12 years of age: do not use this extra strength product. This will provide more than the recommended dose (overdose) and could cause serious health problems.

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Acteminophen 500 mg

OTC - PURPOSE SECTION

Pain reliever / fever reducer

USES

INDICATIONS & USAGE SECTION

temporary relief of minor aches and pains associated with

  • common cold
  • headache
  • toothache
  • muscular aches
  • backache
  • arthritis
  • menstrual cramps
  • temporarily reduces fever

WARNINGS SECTION

Liver Warning: This product contains acetaminophen. Severe liver damage may occur if

  • adult takes more than 4000 mg of acetaminophen in 24 hours
  • taken with other drugs containing acetaminophen
  • adult has 3 or more alcoholic drinks every day while using this product

Allergy Warning: Acetaminophen may cause severe skin reactions. Symptoms may include:

  • skin reddening
  • blisters
  • rash

If a skin reaction occurs, stop use and seek medical help right away.

OTC - DO NOT USE SECTION

Do not use

  • if you are allergic to acetaminophen
  • with any other drug containing acetaminophen (prescription or nonprescription).

If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have liver disease.

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are

taking the blood thinning drug warfarin.

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • symptoms do not improve
  • pain gets worse or lasts for more than 10 days
  • fever gets worse or lasts for more than 3 days
  • new symptoms occur
  • redness or swelling is present
  • a rare sensitivity reaction occurs

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding

ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

In case of accidental overdose, contact a doctor or Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

  • take only as directed - see Overdose warning
  • do not take more than 8 tablets in any 24 hour period
  • do not use more than 10 days unless directed to do so by a doctor

Adults and children 12 years and over: take 2 tablets every 4 to 6 hours.

Children under 12 years of age: do not use this extra strength product. This will provide more than the recommended dose (overdose) and could cause serious health problems.

OTHER INFORMATION

OTHER SAFETY INFORMATION

Tamper evident. Do not use if packet is torn, cut or opened. Store between 20°-25°C (68°-77°F). Read all warnings and directions before use.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

corn starch, povidone, pregelatinized starch, sodium starch glycolate, stearic acid

Non Aspirin Tablet

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

AEROTAB

Non-Aspirin

acetaminophen 500mg

Fever reducer

Pain Reliever

Relieves aches

2 per packet

250250

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
198440acetaminophen 500 MG Oral TabletPSN2
198440acetaminophen 500 MG Oral TabletSCD2
198440APAP 500 MG Oral TabletSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55305-126-022025-02-26C16284748780-12cef2736-a382-d83d-e063-dadaa90ab31fAerotab Non-Aspirin Tablets
55305-126-042025-02-26C16284748780-12cef2736-a382-d83d-e063-dadaa90ab31fAerotab Non-Aspirin Tablets
55305-126-052025-02-26C16284748780-12cef2736-a382-d83d-e063-dadaa90ab31fAerotab Non-Aspirin Tablets
55305-126-022025-01-30C16284748780-12cef2736-a382-d83d-e063-dadaa90ab31fAerotab Non-Aspirin Tablets
55305-126-042025-01-30C16284748780-12cef2736-a382-d83d-e063-dadaa90ab31fAerotab Non-Aspirin Tablets
55305-126-052025-01-30C16284748780-12cef2736-a382-d83d-e063-dadaa90ab31fAerotab Non-Aspirin Tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55305-126-01AeroTab Non-Aspirin2 in 1 PACKETTABLET22
55305-126-02AeroTab Non-Aspirin25 in 1 BOXTABLET252
55305-126-04AeroTab Non-Aspirin50 in 1 BOXTABLET502
55305-126-05AeroTab Non-Aspirin125 in 1 BOXTABLET1252

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55305-126AEROTAB NON-ASPIRIN (ACETAMINOPHEN 500MG ES) TABLET [AERO HEALTHCARE]2Current NDC, 4 package rows20250228_faa3a4ef-3c70-06ca-e053-6394a90a512d.zip

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55305-12655305-126-01, 55305-126-02, 55305-126-04, 55305-126-05

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
POVIDONEFZ989GH94EIACT
STEARIC ACID4ELV7Z65APIACT
STARCH, CORNO8232NY3SJIACT
ACETAMINOPHEN362O9ITL9DACTIB
SODIUM STARCH GLYCOLATE TYPE A CORNAG9B65PV6BIACT

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
AeroTab Non-AspirinACETAMINOPHEN 500MG ESAero Healthcarefaa3a4ef-3c70-06ca-e053-6394a90a512d2025-02-26WarningsExact identifier
ndc (package): 55305-126-01
ndc (package): 55305-126-04
ndc (package): 55305-126-02
ndc (package): 55305-126-05
ndc (product): 55305-126
ndc11 (package): 55305012604
ndc11 (package): 55305012601
ndc11 (package): 55305012602
ndc11 (package): 55305012605
spl id: 2f179527-4b42-8e0d-e063-6394a90a6257
spl set id: faa3a4ef-3c70-06ca-e053-6394a90a512d

Reported adverse events (FAERS/openFDA)#

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