Aerotab Pain Reliever

Manufacturer
Aero Healthcare
Effective date
2023-03-06
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:54:50

Label at a glance#

ProductAerotab Pain Reliever
Active ingredientACETAMINOPHEN, CAFFEINE
Label structure15 sections

Indications and uses

Temporarily relieves minor aches and pains due to: headaches muscular aches

Dosage and administration

do not use more than directed adults and children 12 years and over: take 2 caplets every 6 hours; not more than 8 caplets in 24 hours children under 12 years: ask a doctor

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Drug Facts

Active Ingredients (per tablet)

Acetaminophen 500mg

Caffeine 65mg

PURPOSE

OTC - PURPOSE SECTION

Acetaminophen 500mg.............Pain Reliever / Fever Reducer

Caffeine 65mg...........................Pain Reliever Aid

USES

INDICATIONS & USAGE SECTION

Temporarily relieves minor aches and pains due to:

  • headaches
  • muscular aches

WARNINGS

WARNINGS SECTION

Allergy Alert: 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.

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take

  • more than 8 caplets in 24 hours, which is the maximum daily amount
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product

Caffeine warning: The recommended dose of this product contains about as much caffeine as a cup of coffee. Limit the use of caffeine-containing medications, foods, or beverages while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness, and occasionaly, rapid heartbeat.

OTC - DO NOT USE SECTION

Do not use

  • if you are allergic to ascetaminophen
  • with any other drug containing acetaminophen (prescription or non-prescription). If you are not sure wheter 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

  • ​any new symptoms occur
  • painful area is red or swollen
  • pain gets worse or lasts form ore than 10 days
  • fever gets worse or lasts for more than 3 days.

These could be signs of a serious condition.

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 overdose, get medical help or contact a 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

  • do not use more than directed
  • adults and children 12 years and over: take 2 caplets every 6 hours; not more than 8 caplets in 24 hours
  • children under 12 years: ask a doctor

Other Information

OTHER SAFETY INFORMATION

  • Store at 20-25 C (68-77 F)
  • do not use of pouch is torn or open

Inactive Ingredients

INACTIVE INGREDIENT SECTION

corn starch, croscarmellose sodium, crospovidone, D&C red #27 aluminum lake, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, silicon dioxide, stearic acid, titanium dioxide.

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-845-618-7037

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

AEROTAB

Pain Reliever

fever reducer

Acetaminophen 500mg

Caffeine 65mg

Extra Strength

Relieves aches and pains

Fever reducer

2 per packet

2502501001005050PouchPouch

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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6338270f-96cb-0ecb-6fbb-0a9bc78001f4Product name720250116
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41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
a590be26-846c-8659-a5a1-fb25907965dcProduct name220221110
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e6065d4b-5ae1-476f-a40e-f2851cbb5d2bProduct name220180221
f212291f-05fe-9603-fc7e-bd73e38ce1e6Product name220161129
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
332e86c3-7875-ca6e-f934-2206d2b31996Product name120140508
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7dfac40f-a405-cd2e-7c06-3059ec0e1092Product name120140508
96c2be53-8e44-452d-56a2-d255b2f1af2dProduct name120140508
bf8bd5f7-495f-4022-2780-7ded7ea7ea44Product name120140508
d223c173-c39b-d764-47d4-d671d3088815Product name120140508
e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55305-127-022025-01-30C16284748780-12cef2736-8a3d-d83d-e063-dadaa90ab31fAEROTAB Pain Reliever
55305-127-042025-01-30C16284748780-12cef2736-8a3d-d83d-e063-dadaa90ab31fAEROTAB Pain Reliever
55305-127-052025-01-30C16284748780-12cef2736-8a3d-d83d-e063-dadaa90ab31fAEROTAB Pain Reliever

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55305-127AEROTAB PAIN RELIEVER (PAIN RELIEVER) TABLET [AERO HEALTHCARE]1Unmatched20230502_f63cee1f-8c8a-19e9-e053-2a95a90a854e.zip

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55305-12755305-127-01, 55305-127-02, 55305-127-04, 55305-127-05

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
40e2536b-11d7-831a-e063-6394a90a3a81f63cee1f-8c8a-19e9-e053-2a95a90a854e2025-10-11WarningsExact identifier
spl set id: f63cee1f-8c8a-19e9-e053-2a95a90a854e

Reported adverse events (FAERS/openFDA)#

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