IBUPROFEN FAST RELIEF MEDICINE FOR PAIN- ibuprofen 200 mg tablet 
Allegiant Health

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Drug Facts

Active ingredient (in each tablet)

Ibuprofen USP, 200 mg (NSAID)*
*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever/fever reducer

Uses

temporarily relieves minor aches and pains due to:

Warnings

Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:

If an allergic reaction occurs, stop use and 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

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

Do not use

  • if you have ever had an allergic reaction to any other pain reliever/fever reducer
  • right before or after heart surgery

Ask a doctor before use if

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

Ask a doctor or pharmacist before use if you are

taking aspirin to prevent heart attack or stroke, because ibuprofen may decrease this benefit of aspirin under a doctor’s care for any serious condition taking any other drug

When using this product

take with food or milk if stomach upset occursthe risk of heart attack or stroke may increase if you use more than directed or for longer than directed

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 have stomach pain that does not get better pain gets worse or lasts more
than 10 days ■ fever gets worse or lasts more than 3 days redness or swelling is present in the
painful area any new symptoms appear

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

Ask a doctor before use if

  • stomach bleeding warning applies to you
  • you have problems or serious side effects from taking pain relievers or fever reducers 
  • you have a history of stomach problems, such as heartburn
  • you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or 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 heart attack or stroke, because ibuprofen may decrease this benefit of aspirin
  • taking any other drug

When using this product

take with food or milk if stomach upset occurs

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 
  • have stomach pain that does not get better
  • you have 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 lasts more than 10 days
  • fever gets worse or lasts 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. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

Inactive Ingredients

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

Package/Label Principal Display Panel

HealthA2Z®

Compare to Advil® active ingredient**

FAST RELIEF MEDICINE FOR PAIN

Ibuprofen

(NSAID)*

SEE NEW WARNINGS

Ibuprofen Tablets 200mg

Pain Reliever/Fever Reducer

(pill image)

Tablets

Ibuprofen 200mg

Ibuprofen 200mg

IBUPROFEN  FAST RELIEF MEDICINE FOR PAIN
ibuprofen 200 mg tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69168-335
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN200 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN (UNII: O8232NY3SJ)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TRIACETIN (UNII: XHX3C3X673)  
Product Characteristics
ColorBROWNScoreno score
ShapeROUNDSize10mm
FlavorImprint Code IBU200
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69168-335-01100 in 1 BOX; Type 0: Not a Combination Product12/19/2014
2NDC:69168-335-03250 in 1 BOTTLE; Type 0: Not a Combination Product12/19/2014
3NDC:69168-335-3030 in 1 BOX; Type 0: Not a Combination Product12/19/2014
4NDC:69168-335-4040 in 1 BOX; Type 0: Not a Combination Product12/19/2014
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07912912/19/2014
Labeler - Allegiant Health (079501930)
Establishment
NameAddressID/FEIBusiness Operations
Strides Shasun Limited871402375ANALYSIS(69168-335) , MANUFACTURE(69168-335)

Revised: 11/2017
Document Id: efd20a4b-fd12-46e4-ad80-5065264a4203
Set id: dd63b011-0573-4374-9669-8d29146e5fc9
Version: 7
Effective Time: 20171117
 
Allegiant Health