Label: AEROTAB IBUPROFEN- ibuprofen tablet tablet, coated
55305-133-04, view more55305-133-05
- Packager: Aero Healthcare
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Updated April 29, 2022
If you are a consumer or patient please visit this version.
- ACTIVE INGREDIENT
- INDICATIONS & USAGE
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
• 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
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
- 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
- KEEP OUT OF REACH OF CHILDREN
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
- INACTIVE INGREDIENTS
- PRODUCT PACKAGE
INGREDIENTS AND APPEARANCE
ibuprofen tablet tablet, coated
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55305-133 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN 200 mg in 1000 mg Inactive Ingredients Ingredient Name Strength 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 Color brown Score no score Shape ROUND Size 10mm Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55305-133-02 25 in 1 BOX 01/01/2018 1 NDC:55305-133-01 2 mg in 1 PACKET; Type 0: Not a Combination Product 2 NDC:55305-133-03 25 in 1 BOX 01/01/2018 2 NDC:55305-133-01 2 mg in 1 PACKET; Type 0: Not a Combination Product 3 NDC:55305-133-04 50 in 1 BOX 01/01/2018 3 NDC:55305-133-01 2 mg in 1 PACKET; Type 0: Not a Combination Product 4 NDC:55305-133-05 125 in 1 BOX 01/01/2018 4 NDC:55305-133-01 2 mg in 1 PACKET; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA091239 01/01/2018 Labeler - Aero Healthcare (008186174)