Indications & Usage
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
Flex-prin Tablet
FDA Label NDC 69103-2525
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Provision Medical Products for the product Flex-prin (NDC 69103-2525). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding indications & usage, otc - pregnancy or breast feeding, otc - keep out of reach of children, warnings, dosage & administration, inactive ingredient, otc - active ingredient, otc - purpose, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Pregnancy 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 directed to do so by a doctor because it may
cause problems in the unborn
child or complications during delivery.
Otc - 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.
Warnings
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
Dosage & Administration
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 Ingredient
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.
Otc - Active Ingredient
ACTIVE INGREDIENT-IBUPROFEN 200 MG
Otc - Purpose
PAIN RELIEVER/FEVER REDUCER
Package Label.Principal Display Panel
Flex Prin Box (Ibuprofen)
* Please review the disclaimer below.
