IBUPROFEN COLD AND SINUS A P J- ibuprofen, pseudoephedrine hydrochloride tablet, coated 
A P J Laboratories Limited

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IBUPROFEN

PSEUDOEPHEDRINE HYDROCHLORIDE

Pain reliever/Fever reducer

Nasal decongestant




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

uses

temporarily relieves these symptoms associated with the common cold or flu:

•fever

•sinus pressure

•nasal congestion

•headache

•minor body aches and pains



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




•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.

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

•CALCIUM CARBONATE

•STARCH, CORN

•METHYLPARABEN

•PROPYLPARABEN

•SODIUM STARCH GLYCOLATE TYPE A POTATO

•TALC

•MAGNESIUM STEARATE

•SILICON DIOXIDE

•CROSCARMELLOSE SODIUM

•SODIUM LAURYL SULFATE

•ISOPROPYL ALCOHOL

•METHYLENE CHLORIDE

•TITANIUM DIOXIDE

product

IBUPROFEN COLD AND SINUS  A P J
ibuprofen, pseudoephedrine hydrochloride tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:46084-091
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN200 mg
PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE30 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorwhiteScoreno score
ShapeROUNDSize15mm
FlavorImprint Code 091
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:46084-091-6020 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07456706/01/2013
Labeler - A P J Laboratories Limited (677378339)
Registrant - A P J Laboratories Limited (677378339)
Establishment
NameAddressID/FEIBusiness Operations
A P J Laboratories Limited677378339manufacture(46084-091)

Revised: 4/2013
Document Id: 14d51b10-696d-4626-bb3b-143cde538b2f
Set id: db492dad-ab1c-459d-842c-062e4b3f4c57
Version: 1
Effective Time: 20130429
 
A P J Laboratories Limited