Aerotab Non-aspirin Tablet
FDA Label NDC 55305-126

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Aero Healthcare for the product Aerotab Non-aspirin (NDC 55305-126). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, uses, warnings, otc - do not use, otc - ask doctor, otc - ask doctor/pharmacist, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Otc - Active Ingredient

→ Otc - Purpose

→ Uses

→ Warnings

→ Otc - Do Not Use

→ Otc - Ask Doctor

→ Otc - Ask Doctor/pharmacist

→ Otc - Stop Use

→ Otc - Pregnancy Or Breast Feeding

→ Otc - Keep Out Of Reach Of Children

→ Directions

→ Other Information

→ Inactive Ingredients

→ Package Label.principal Display Panel

Otc - Active Ingredient

Acteminophen 500 mg

Otc - Purpose

Pain reliever / fever reducer

Uses

temporary relief of minor aches and pains associated with

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

Warnings

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

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

Ask a doctor before use if you have liver disease.

Otc - Ask Doctor/Pharmacist

Ask a doctor or pharmacist before use if you are

taking the blood thinning drug warfarin.

Otc - Stop Use

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

If pregnant or breast-feeding

ask a health professional before use.

Otc - Keep Out Of Reach Of Children

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

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.