Aerotab Ibuprofen Tablet, Coated
FDA Label NDC 55305-133

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 Ibuprofen (NDC 55305-133). 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 active ingredient, purpose, indications & usage, warnings, ask a doctor before use, when using this product, stop use and ask a doctor, if pregnant or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Active Ingredient

→ Purpose

→ Indications & Usage

→ Warnings

→ Ask A Doctor Before Use

→ When Using This Product

→ Stop Use And Ask A Doctor

→ If Pregnant Or Breast Feeding

→ Keep Out Of Reach Of Children

→ Dosage & Administration

→ Other Information

→ Inactive Ingredients

→ Product Package

Active Ingredient

Drug Facts

Active Ingredient (in each tablet)
Ibuprofen 200 mg (NSAID)*

Purpose

Ibuprofen 200 mg (NSAID)*.............Pain Reliever Fever Reducer

*nonsteroidal anti-inflammatory drug

Indications & Usage

Uses:
Temporarily Relieves minor aches and pains
due to:
• Headache, toothaches, backache, menstrual cramps,
the common cold,
• muscular aches, minor pain of arthritis
Temporarily reduces fever

Warnings

Warnings:

Allergy Alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin.
Symptoms may include:
• hives, facial swelling, asthma (wheezing), shock,
skin reddening, rash, blisters. If an allergic reaction occurs stop use an dseek medical help right away.

Stomach bleeding warning: This product contains a nonsteroidal anti-inflammatory drug (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 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

Heart attack and stroke warning: NSAIDs, except aspirin, increase the risk of heart attack, heart failure, stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed.

Ask A Doctor Before Use

Ask a doctor before use if

stomach bleeding warning applies to you
you have problems or serious side effects from taking pain relievers or frever reducers
you have a history of stomach problems, such as heartburn
you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, had a stroke, you are taking a diuretic

Ask a doctor or pharmacist before use if

you are under a doctor's care for any serious condition
Taking aspirin for a heart attack or stroke, because ibuprofen may decrease this benefit of asprin
taking any other drug

When Using This Product

When using this product take with food or milk if stomach upset occurs

Stop Use And Ask A Doctor

Stop use and ask a doctor if you experience any of the following signs of stomach bleeding:

feel faint
vomit
blood
have bloody or black stools
stomach pain that does not get better
symptoms of heart problems or stroke
chest pain
trouble breathing
weakness in one part or side of body
slurred speech
leg swelling
pain gets worse or last more than 10 days
fever gets worse or last more than 3 days
redness or swelling is present in the painful area
any new symptoms appear

If Pregnant Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use ibuprofen 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

Keep out of reach of children.

Overdose warning: In case of overdose, seek 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.

Dosage & Administration

Directions: take only as directed - see Overdose warning.

Adults and children 12 years of age and older take 1 tablet every 4 to 6 hours while symptoms persist, if pain or fever does not respond to 1 tablet, 2 tablets may be used. Do not exceed 6 tablets in 24 hoiurs, unless directed by a doctor.

Children under 12 years ask a doctor. Do not take more than directed (see overdose warning). The smallest effective dose should be used.

Other Information

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

Inactive Ingredients

Inactive Ingredients:

corn starch, hypromellose, red iron oxide, magnesium stearate, microcrystalline cellulose, pregelatinized starch,silicon dioxide, sodium starch glycolate, talc, titanium dioxide, triacetin