IBUPROFEN 200MG- ibuprofen tablet 
Allegiant Health

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381 - Ibuprofen 200mg Tablet

Active ingredient(s)

Ibuprofen USP, 200mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Purpose

Pain Reliever/Fever reducer

Use(s)

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 chances are 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 you
  • you 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

  • 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

Pregnancy/Breastfeeding

If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use ibuprofen at

20 weeks or later in 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

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions


Other information

Inactive ingredients

colloidal silicon dioxide, corn starch, FD&C yellow #6, hypromellose, polydextrose, polyethylene
glycol, povidone, pregelatinized starch, purified water, sodium starch glycolate, stearic acid, titanium dioxide

Questions

Call 1-888-952-0050 Monday through Friday 9AM – 5PM EST

Principal Display Panel

Ibuprofen label

Ibuprofen label

Ibuprofen

Ibuprofen


IBUPROFEN 200MG 
ibuprofen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69168-381
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN200 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STARCH, CORN (UNII: O8232NY3SJ)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
POLYDEXTROSE (UNII: VH2XOU12IE)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POVIDONE (UNII: FZ989GH94E)  
WATER (UNII: 059QF0KO0R)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
Product Characteristics
ColorbrownScoreno score
ShapeROUNDSize10mm
FlavorImprint Code G2
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69168-381-03250 in 1 BOTTLE; Type 0: Not a Combination Product11/16/2021
2NDC:69168-381-011 in 1 CARTON11/16/2021
2100 in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:69168-381-301 in 1 CARTON11/16/2021
330 in 1 BOTTLE; Type 0: Not a Combination Product
4NDC:69168-381-401 in 1 CARTON11/16/2021
440 in 1 BOTTLE; Type 0: Not a Combination Product
5NDC:69168-381-05500 in 1 BOTTLE; Type 0: Not a Combination Product11/16/2021
6NDC:69168-381-32100 in 1 BOTTLE; Type 0: Not a Combination Product05/18/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07917411/16/2021
Labeler - Allegiant Health (079501930)

Revised: 11/2021
Document Id: ccb176fa-b1be-4552-ab01-c8a0643e063c
Set id: f3f12b86-89dc-427e-a26f-728be6f73e7b
Version: 3
Effective Time: 20211116
 
Allegiant Health