IBUPROFEN- ibuprofen tablet 
New World Imports

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

Ibuprofen 200mg

Pain reliever / fever reducer

In case of overdose, get medical help or contact a Poison Control Center right away

Temporarily relieves minor aches and pains due to:

Headache, muscular aches, minor pain of arthritis, toothache, backache, common cold and menstrual cramps

Temporarily reduces fever


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, seek 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 60 years or older, have had stomach ulcers or bleeding problems, take a blood thinning (anticoaglant) or steroid drug, take other drugs containing a NSAID [aspirin, ibuprofen,  naproxen, or others], have 3 or more alcoholic drinks every day while using this product, or take more / for a longer time than directed.

Do not use if you have ever had a n allergic reaction to any other pain reliever / fever reducer or right before / after heart surgery.

Ask a doctor before use if you have: problems or serious side effects from taking pain relievers or fever reducers.  Stomach problems that last or come back, such as heartburn, upset stomach, or stomach pain.  Ulcers, bleeding problems, high blood pressure, hear or kidney disease, taken a diuretic, or reached age 60 or older.

Ask a doctor or pharmacist before use if you are:taking any other drug containing a NSAID (prescription or nonprescription), under a doctors care for any serious condition, taking a blood thinning (anticoagulant) or steroid drug, or taking any other drug.

When using this product: take with food or milk if stomach upset occurs.  Long term continuous use may increase the risk of heart attack or stroke.

Stop use and ask a doctor if: You feel faint, vomit blood, or have bloody or black stools.  These are signs of stomach bleeding.  Pain gets worse or last more than 10 days.  Fever gets worst or last for mare than 3 days.  Stomach pain or upset gets worse or lasts.  Redness or swelling is present in the painful area.  Any new symptoms occur.  You may report side effects to 1-888-952-0050.

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.

Do not take more than directed.  The smallest effective dose should be used. Do not take longer thank 10 days, unless directed by a doctor (see warnings)

Adult and children 12 years and older: Take 1 tablets every 4 to 6 hours while symptoms persist.  If pain or fever does not respond to 1 tablets, 2 tablets may be used.  Do not exceed 6 tablets in 24 hours unless directed by a doctor.

Children under 12 years: ask a doctor

Anhydrous lactose, carnauba wax, colloidal silicon dioxide, corn starch, hypromellose, iron oxide red, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, povidone, sodium lauryl sulfate, sodium starch glycolate, titanium dioxide

Label

IBUPROFEN 
ibuprofen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51824-245
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Ibuprofen (UNII: WK2XYI10QM) (Ibuprofen - UNII:WK2XYI10QM) Ibuprofen200 mg
Inactive Ingredients
Ingredient NameStrength
Anhydrous Lactose (UNII: 3SY5LH9PMK)  
Carnauba Wax (UNII: R12CBM0EIZ)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
Starch, Corn (UNII: O8232NY3SJ)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
Magnesium stearate (UNII: 70097M6I30)  
Cellulose, Microcrystalline (UNII: OP1R32D61U)  
Polydextrose (UNII: VH2XOU12IE)  
Polyethylene Glycol (UNII: 3WJQ0SDW1A)  
Povidone (UNII: FZ989GH94E)  
Sodium Lauryl Sulfate (UNII: 368GB5141J)  
Sodium starch glycolate type A potato (UNII: 5856J3G2A2)  
Titanium dioxide (UNII: 15FIX9V2JP)  
Product Characteristics
Colorbrown (Rusty brown color) Scoreno score
ShapeROUND (Round) Size10mm
FlavorImprint Code IP;140
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51824-245-01100 in 1 BOTTLE; Type 0: Not a Combination Product09/10/201006/01/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34309/10/201006/01/2016
Labeler - New World Imports (075372276)

Revised: 8/2017
 
New World Imports