PROPRINAL- ibuprofen tablet, sugar coated

Proprinal by

Drug Labeling and Warnings

Proprinal by is a Otc medication manufactured, distributed, or labeled by NorMed. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient (in each tablet)

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

INDICATIONS & USAGE

Temporarily  relieves minor aches and pains due to:

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

Temporarily reduces fever

WARNINGS

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

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 DOCTOR

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 DOCTOR/PHARMACIST

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

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

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
  

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 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

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

DOSAGE & ADMINISTRATION

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

PURPOSE

Ibuprofen...to reduce pain and fever

INACTIVE INGREDIENT

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PROPRINAL 
ibuprofen tablet, sugar coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50332-0109
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ibuprofen (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM)	ibuprofen	200 mg

Inactive Ingredients
Ingredient Name	Strength
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
Color	white	Score	no score
Shape	ROUND	Size	11mm
Flavor		Imprint Code	P
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50332-0109-4	100 in 1 BOX, UNIT-DOSE
2	NDC: 50332-0109-7	250 in 1 BOX, UNIT-DOSE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part343	06/01/1990

Labeler - NorMed (069560969)