Label: IBUPROFEN COLD AND SINUS A P J- ibuprofen, pseudoephedrine hydrochloride tablet, coated
-
Contains inactivated NDC Code(s)
NDC Code(s): 46084-091-60 - Packager: A P J Laboratories Limited
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated April 29, 2013
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- uses
-
WARNINGS
Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:
•hives
•facial swelling
•asthma (wheezing)
•shock
•skin reddening
•rash
•blisters
If an allergic reaction occurs, stop use and seek medical help right away.
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 a blood thinning (anticoagulant) or steroid drug
•take other drugs containing prescription or nonprescription NSAIDs, [aspirin, ibuprofen, naproxen, or others]
•have 3 or more alcoholic drinks every day while using this product
•take more or for a longer time than directed
-
DOSAGE & ADMINISTRATION
•do not take more than directed
•the smallest effective dose should be used.
•adults and children 12 years of age and over:
•take 1 caplet every 4 to 6 hours while symptoms persist. If symptoms do not respond to 1 caplet, 2 caplets may be used.
•do not use more than 6 caplets in any 24-hour period unless directed by a doctor.
•children under 12 years of age: do not use.
-
DO NOT USE
if you have ever had an allergic reaction to any other pain reliever/fever reducer
•if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
•in children under 12 years of age
•right before or after heart surgery
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
IBUPROFEN COLD AND SINUS A P J
ibuprofen, pseudoephedrine hydrochloride tablet, coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:46084-091 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN 200 mg PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg Inactive Ingredients Ingredient Name Strength CALCIUM CARBONATE (UNII: H0G9379FGK) 20 mg STARCH, CORN (UNII: O8232NY3SJ) 8 mg METHYLPARABEN (UNII: A2I8C7HI9T) .5 mg PROPYLPARABEN (UNII: Z8IX2SC1OH) .2 mg SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) 6 mg TALC (UNII: 7SEV7J4R1U) 4 mg MAGNESIUM STEARATE (UNII: 70097M6I30) 3 mg SILICON DIOXIDE (UNII: ETJ7Z6XBU4) 1 mg CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) 1.5 mg SODIUM LAURYL SULFATE (UNII: 368GB5141J) 1 mg ISOPROPYL ALCOHOL (UNII: ND2M416302) 60 mg METHYLENE CHLORIDE (UNII: 588X2YUY0A) 150 mg TITANIUM DIOXIDE (UNII: 15FIX9V2JP) 1.5 mg Product Characteristics Color white Score no score Shape ROUND Size 15mm Flavor Imprint Code 091 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:46084-091-60 20 in 1 BLISTER PACK Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA074567 06/01/2013 Labeler - A P J Laboratories Limited (677378339) Registrant - A P J Laboratories Limited (677378339) Establishment Name Address ID/FEI Business Operations A P J Laboratories Limited 677378339 manufacture(46084-091)
