PROPRINAL - ibuprofen tablet, sugar coated 
NorMed

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Proprinal

Active Ingredient (in each tablet)

Ibuprofen (NSAID)* 200mg (*nonsteroidal anti-inflammatory drug)...Pain Reliever/Fever Reducer


Temporarily  relieves minor aches and pains due to:

Temporarily reduces fever

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

Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:


Do not use


Ask a doctor before use if

Ask a doctor or pharmacist if you are



When using this product


Stop use and ask a doctor if

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

Directions: do not take more than directed; the smallest effective dose should be used. Adults and children 12 years of age and over:

children under 12 years of age: ask a doctor


Ibuprofen...to reduce pain and fever

Inactive ingredients:

Carnauba Wax, Croscarmellose Sodium, Hydroxypropyl Methylcellulose, Microcrystalline Cellulose, Polyethylene Glycol, Polysorbate 80, Povidone, Pregelatinized Starch, Silicon Dioxide, Sodium Starch Clycolate, Stearic Acid, Titanium Dioxide

5691 Proprinal 11s.jpg
PROPRINAL 
ibuprofen tablet, sugar coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50332-0109
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ibuprofen (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) ibuprofen200 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
POVIDONE (UNII: FZ989GH94E)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorwhiteScoreno score
ShapeROUNDSize11mm
FlavorImprint Code P
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50332-0109-4100 in 1 BOX, UNIT-DOSE
2NDC:50332-0109-7250 in 1 BOX, UNIT-DOSE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34306/01/1990
Labeler - NorMed (069560969)

Revised: 6/2012
Document Id: bf79ff33-0c19-4066-afe4-a14a118bb067
Set id: af75f914-6385-42f7-9900-c3c6929b07df
Version: 1
Effective Time: 20120619
 
NorMed