Label: PROPRINAL- ibuprofen tablet, sugar coated
-
Contains inactivated NDC Code(s)
NDC Code(s): 50332-0109-4, 50332-0109-7 - Packager: NorMed
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated June 19, 2012
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- INDICATIONS & USAGE
-
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
- ASK DOCTOR
- ASK DOCTOR/PHARMACIST
- WHEN USING
-
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
- KEEP OUT OF REACH OF CHILDREN
-
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
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
PROPRINAL
ibuprofen tablet, sugar coatedProduct 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)