IBUPROFEN COLD AND SINUS description, usages, side effects, indications, overdosage, supplying and lots more!

Menu
Search

IBUPROFEN COLD AND SINUS

A P J Laboratories Limited
A P J Laboratories Limited


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient

IBUPROFEN

PSEUDOEPHEDRINE HYDROCHLORIDE

Purpose

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

IBUPROFEN COLD AND SINUS

IBUPROFEN, PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, COATED

Product Information

Product Type Human otc drug label Item Code (Source) NDC:46084-091
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
IBUPROFEN IBUPROFEN 200 mg
Pseudoephedrine Hydrochloride Pseudoephedrine 30 mg

Inactive Ingredients

Ingredient Name Strength
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 Characteristics

Color Size Imprint Code Shape
white 15 mm 091 ROUND

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 2013-06-01


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
Copyright © 2014. drugs-library.com. All rights reserved. Information on drugs-library.com is provided for educational purposes only and is not to be used for medical advice, diagnosis or treatment.
Support info@drugs-library.com.