Proprinal

Dosage form: tablet, sugar coated
Ingredients: ibuprofen 200mg
Labeler: NorMed
NDC Code: 50332-0109

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.

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:

  • headache
  • muscular aches
  • backache
  • minor arthritis pain
  • the common cold
  • toothache
  • menstrual cramps

Temporarily reduces fever

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

  • hives
  • rash
  • shock
  • facial swelling
  • asthma (wheezing)
  • skin reddening
  • blisters

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

  • are age 60 or older
  • have had stomach ulcers or bleeding problems
  • take more or for a longer time than directed
  • take a blood thinning (anticoagulant) or steroid drug
  • have 3 or more alcohol drinks every day while using this product
  • take other drugs containing prescription or non-prescription NSAIDs (aspirin, ibuprofen, naproxen, or others)


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

  • stomach bleeding warning applies to you
  • you have a history of stomach problems, such as heartburn
  • you are taking a diuretic
  • you have high blood pressure, heart disease, liver cirrhosis, or kidney disease

Ask a doctor or pharmacist if you are

  • unders a doctor's care for any serious condition
  • taking any other drug containing an NSAID
  • taking a blood thinning (anticoagulant) or steroid drug
  • taking aspirin for heart attack or stroke (ibuprofen may decrease the benefit of aspirin)



When using this product

  • take with food or milk if stomach upset occurs
  • long term continuous use may increase the risk of heart attack or stroke


Stop use and ask a doctor if

  • an allergic reaction occurs, seek medical help right away
  • fever gets worse or lasts more than 3 days
  • pain gets worse or lasts more than 10 days
  • redness or swelling is present in the painful area.
  • new symptoms occur
  • you have any of the following signs of stomach bleeding: feel faint, vomit blood, have bloody or black stools, or stomach pain that does not get better

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:

  • take 1 tablet every 4 to 6 hours while symptoms persist
  • if pain or fever does not respond to 1 tablet, 2 tablets may be used
  • do not take more than 6 tablets in 24 hours unless directed by a doctor

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

PROPRINAL 
ibuprofen tablet, sugar coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50332-0109
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ibuprofen (IBUPROFEN) ibuprofen200 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM 
CELLULOSE, MICROCRYSTALLINE 
POLYETHYLENE GLYCOLS 
POLYSORBATE 80 
POVIDONE 
SILICON DIOXIDE 
STEARIC ACID 
TITANIUM DIOXIDE 
Product Characteristics
ColorwhiteScoreno score
ShapeROUNDSize11mm
FlavorImprint CodeP
Contains    
Packaging
#Item CodePackage Description
1NDC:50332-0109-4100 TABLET, SUGAR COATED (TABLET) in 1 BOX, UNIT-DOSE
2NDC:50332-0109-7250 TABLET, SUGAR COATED (TABLET) 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: 06/2012
 
NorMed

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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