FDA Label for Aerotab Ibuprofen
View Indications, Usage & Precautions
Aerotab Ibuprofen Product Label
The following document was submitted to the FDA by the labeler of this product Aero Healthcare. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredient
Drug Facts
Active Ingredient (in each tablet)
Ibuprofen 200 mg (NSAID)*
Purpose
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
- 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
Ask a doctor or pharmacist before use if
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
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
Product Package
AeroTab
Ibuprofen USP 200mg
Anti-inflammatory
Fever reducer
Pain reliever
250
2 per packet
* Please review the disclaimer below.
