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IBUPROFEN COLD AND SINUS A P J

Medically reviewed on April 30, 2018

Dosage form: tablet, coated
Ingredients: IBUPROFEN 200mg, PSEUDOEPHEDRINE HYDROCHLORIDE 30mg
Labeler: A P J Laboratories Limited
NDC Code: 46084-091

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

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 AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (IBUPROFEN) IBUPROFEN200 mg
PSEUDOEPHEDRINE HYDROCHLORIDE (PSEUDOEPHEDRINE) PSEUDOEPHEDRINE HYDROCHLORIDE30 mg
Inactive Ingredients
Ingredient NameStrength
CALCIUM CARBONATE20 mg
STARCH, CORN8 mg
METHYLPARABEN.5 mg
PROPYLPARABEN.2 mg
SODIUM STARCH GLYCOLATE TYPE A POTATO6 mg
TALC4 mg
MAGNESIUM STEARATE3 mg
SILICON DIOXIDE1 mg
CROSCARMELLOSE SODIUM1.5 mg
SODIUM LAURYL SULFATE1 mg
ISOPROPYL ALCOHOL60 mg
METHYLENE CHLORIDE150 mg
TITANIUM DIOXIDE1.5 mg
Product Characteristics
ColorwhiteScoreno score
ShapeROUNDSize15mm
FlavorImprint Code091
Contains    
Packaging
#Item CodePackage Description
1NDC:46084-091-6020 TABLET, COATED (TABLET) 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/FEIOperations
A P J Laboratories Limited677378339manufacture(46084-091)

 
A P J Laboratories Limited

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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