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Flex-Prin

Medically reviewed on Apr 3, 2018

Dosage form: tablet
Ingredients: IBUPROFEN 200mg
Labeler: Provision Medical Products
NDC Code: 69103-2525

Uses: temporarily relieves minor aches and pains due to:•headache • minor pain of arthritis • the common cold • toothache • backache • menstrual cramps • muscular aches • temporarily reduces fever

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 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 right

away.

Warnings:

Allergy Alert: Ibuprofen may cause a severe allergic

reaction which may include:

• hives • shock • facial swelling • asthma (wheezing)

Alcohol Warning: If you consume 3 or more alcoholic

drinks every day, ask your doctor whether you should

take Ibuprofen or other pain relievers/ fever reducers.

Ibuprofen may cause stomach bleeding.

Do not use:

• if you have ever had an allergic reaction to any

other pain reliever/fever reducer

Ask a doctor before use if you have:

• stomach pain

• problems or serious side eects from taking

pain relievers or fever reducers

Ask a doctor or pharmacist before use if you are:

• under a doctor's care for any serious condition

• taking any other drug

• taking any other product that contains Ibuprofen,

or any other pain reliever/fever reducer

When using this product give with food or milk if

stomach upset occurs.

Stop use and ask a doctor if:

• an allergic reaction occurs. Seek medical help right

away • pain gets worse or lasts more than 10 days

• fever gets worse or lasts more than 3 days

• stomach pain or upset gets worse or lasts

• any new symptoms appear • redness or swelling is

present in the painful area

Directions:

• Do not take more than directed.

Adults and children 12 years and older

• Take 1  tablet every 4 to 6  hours while symptoms

• If pain or fever does not respond to 1 tablet, 2 tablets may be used.

Do not exceed 6 tablets in 24 hours, unless as directed by a doctor.

• The smallest effective dose should be used.

Children under 12 year

• Ask a doctor.

Inactive Ingredients:

carnauba wax, croscarmellose sodium,

hydroxypropyl methylcellulose,

microcrystalline cellulose,

polyethylene glycol, polysorbate 80,

povidone, pregelatinized starch, silicon

dioxide, sodium starch glycolate,

stearic acid and titanium dioxide.

ACTIVE INGREDIENT-IBUPROFEN 200 MG

PAIN RELIEVER/FEVER REDUCER

FLEX-PRIN 
ibuprofen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69103-2525
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (IBUPROFEN) IBUPROFEN200 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM 
CARNAUBA WAX 
HYPROMELLOSES 
POLYETHYLENE GLYCOL 400 
STEARIC ACID 
CELLULOSE, MICROCRYSTALLINE 
POVIDONE K30 
STARCH, PREGELATINIZED CORN 
POLYSORBATE 80 
SILICON DIOXIDE 
TITANIUM DIOXIDE 
TALC 
Product Characteristics
ColorbrownScoreno score
ShapeROUNDSize10mm
FlavorImprint CodeIBU200
Contains    
Packaging
#Item CodePackage Description
1NDC:69103-2525-5250 PACKET in 1 CARTON
12 TABLET in 1 PACKET
2NDC:69103-2525-6100 PACKET in 1 CARTON
22 TABLET in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07912903/31/2015
Labeler - Provision Medical Products (036936831)
Registrant - Provision Medical Products (036936831)
Establishment
NameAddressID/FEIOperations
Ultraseal Corporation085752004pack(69103-2525)
Establishment
NameAddressID/FEIOperations
SHASUN PHARMACEUTICALS LIMITED915786829manufacture(69103-2525)

 
Provision Medical Products

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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