Ibuprofen Cold And Sinus
FDA Label NDC 46084-091

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by A P J Laboratories Limited for the product Ibuprofen Cold And Sinus (NDC 46084-091). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, otc - keep out of reach of children, uses, warnings, dosage & administration, otc - do not use, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

IBUPROFEN

PSEUDOEPHEDRINE HYDROCHLORIDE

Otc - Purpose

Pain reliever/Fever reducer

Nasal decongestant




Otc - 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.

Otc - 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

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