IBUPROFEN- ibuprofen tablet 
Trifecta Pharmaceuticals USA LLC

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Ibuprofen Tablets 200mg

Active Ingredient (in each tablet)

Ibuprofen, 200mg (NSAID*)

*nonsteroidal anti-inflammatory drug

Purpose

Pain Releiver / Fever Reducer

nonsteroidal anti-inflammatory drug

Do Not Use

Uses

Temporarily relieves minor aches and pains due to

temporarily reduces fever

Warnings

Allergy alert

Ibuprofen may cause severe allergic reactions, 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 NSAID, which may cause severe stomach bleeding. The chances are higher if you:

Heart attack or 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.

Contains FD+C Yellow No. 5 (tartrazine) as a color additive

Ask a doctor before use if

Ask a doctor or pharmacist before use if you are

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 right away (1-800-222-1222).

Directions

Adults and children 12 years and older

Children under 12 years of age

Stop Use and ask a doctor if

You experience any of the following signs of stomach bleeding:

You have symptoms of heart problems or stroke

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.

Other Information

TAMPER EVIDENT child resistant packets. Do not use any opened or torn packets.

Inactive Ingredients

Colloidal Silicon Dioxide, Croscarmellose Sodium, FD&C Blue #2, FD&C Yellow #5, FD&C Yellow #6, Iron Oxide Red, Lecithin, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Polyvinyl Alcohol, Pregelatinized Starch, Talc, Titanium Dioxide

Questions or Comments?

Call 1-888-296-9067

IMPORTANT: READ ALL PRODUCT INFORMATION BEFORE USING. KEEP BOX FOR COMPLETE WARNINGS AND INFORMATION.

When using this product

Take with food or milk if stomach upset occurs

Distributed By:

Distributed By:

Trifecta Pharmaceuticals USA®

Ft. Lauderdale, FL. 33301 USA

1-888-296-9067

*This product is not manufactured or distributed by Pfizer, owner of the registered trademark Advil®

Reorder No. 2022

Made in the USA

globe ibuprofin 200mg 50pk child resistant CDER

IBUPROFEN 
ibuprofen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69396-145
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN200 mg
Inactive Ingredients
Ingredient NameStrength
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
POLYETHYLENE GLYCOL 4000 (UNII: 4R4HFI6D95)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STARCH, CORN (UNII: O8232NY3SJ)  
TALC (UNII: 7SEV7J4R1U)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorbrownScoreno score
ShapeROUNDSize10mm
FlavorImprint Code BI06
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69396-145-0150 in 1 BOX08/08/2023
12 in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20709508/08/2023
Labeler - Trifecta Pharmaceuticals USA LLC (079424163)

Revised: 11/2023
Document Id: 09970125-f920-00c3-e063-6394a90a219e
Set id: 09972806-e064-238d-e063-6394a90a7434
Version: 1
Effective Time: 20231107
 
Trifecta Pharmaceuticals USA LLC