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

IBUPROFEN COLD AND SINUS by

Drug Labeling and Warnings

IBUPROFEN COLD AND SINUS by is a Otc medication manufactured, distributed, or labeled by A P J Laboratories Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

IBUPROFEN

PSEUDOEPHEDRINE HYDROCHLORIDE

PURPOSE

Pain reliever/Fever reducer

Nasal decongestant

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).

uses

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

fever

sinus pressure

nasal congestion

headache

minor body aches and pains

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

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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

Product 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)