AEROTAB IBUPROFEN- ibuprofen tablet tablet, coated 
Aero Healthcare

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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

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:

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

50 Tablet Box100 Tablet Box250 Tablet Box2 Tablet Packet

AEROTAB IBUPROFEN 
ibuprofen tablet tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55305-133
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN200 mg  in 1000 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN (UNII: O8232NY3SJ)  
TALC (UNII: 7SEV7J4R1U)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)  
POLYVINYL ALCOHOL (100000 MW) (UNII: 949E52Z6MY)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
Product Characteristics
ColorbrownScoreno score
ShapeROUNDSize10mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55305-133-0225 in 1 BOX01/01/2018
1NDC:55305-133-012 mg in 1 PACKET; Type 0: Not a Combination Product
2NDC:55305-133-0325 in 1 BOX01/01/2018
2NDC:55305-133-012 mg in 1 PACKET; Type 0: Not a Combination Product
3NDC:55305-133-0450 in 1 BOX01/01/2018
3NDC:55305-133-012 mg in 1 PACKET; Type 0: Not a Combination Product
4NDC:55305-133-05125 in 1 BOX01/01/2018
4NDC:55305-133-012 mg in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09123901/01/2018
Labeler - Aero Healthcare (008186174)

Revised: 4/2022
Document Id: ddd0f7fb-ae4c-c584-e053-2a95a90a0984
Set id: ddd0f7fb-ae4b-c584-e053-2a95a90a0984
Version: 1
Effective Time: 20220429
 
Aero Healthcare