Ibuprofen and Pseudoephedrine HCl IBUPROFEN AND PSEUDOEPHEDRINE HCL CARDINAL HEALTH FDA Approved Uses temporarily relieves these symptoms associated with the common cold or flu: headache sinus pressure nasal congestion minor body aches and pains fever
FunFoxMeds box
Substance Ibuprofen
Route
ORAL
Applications
ANDA209235
Package NDC

Drug Facts

Composition & Profile

Active Ingredients
Drug Facts Active ingredients (in each liquid-filled capsule) Solubilized ibuprofen equal to 200 mg ibuprofen USP (NSAID)* (present as the free acid and potassium salt) Pseudoephedrine Hydrochloride USP 30 mg *nonsteroidal anti-inflammatory drug
Inactive Ingredients
Inactive ingredients Black iron oxide D&C yellow no. 10 gelatin hypromellose neelicert FD&C red no. 40 polyethylene glycol potassium hydroxide propylene glycol sorbitol sorbitan solution. Questions or comments? call 1-855-274-4122 DISTRIBUTED BY CARDINAL HEALTH DUBLIN OHIO 43017 www.myleader.com 1-800-200-6313 Made in India Code: TS/DRUGS/16/2014
Strengths
200 mg 30 mg
Quantities
10 capsules
Treats Conditions
Uses Temporarily Relieves These Symptoms Associated With The Common Cold Or Flu Headache Sinus Pressure Nasal Congestion Minor Body Aches And Pains Fever
Pill Appearance
Shape: oval Color: orange Imprint: IBP200

Identifiers & Packaging

Container Type BOX
All Product Codes
UNII
WK2XYI10QM 6V9V2RYJ8N
Packaging

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 200 mg/30 mg (20 Liquid-Filled Capsules) LEADER TM NDC 70000-0606-1 Non-Drowsy Cold & Sinus Relief Ibuprofen 200 mg - Pain Reliever/Fever Reducer (NSAID) Pseudoephedrine HCl 30 mg - Nasal Decongestant Ibuprofen and Pseudoephedrine HCl Capsules 200 mg/30 mg Relieves Sinus Pressure Nasal Congestion and Fever 20 LIQUID-FILLED CAPSULES (2 X 10 Capsules per Blister Card) Actual Size COMPARE TO ADVIL ® COLD & SINUS active ingredients * 100% Money Back Guarantee PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 200 mg/30 mg (20 Liquid-Filled Capsules)

Package Descriptions
  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 200 mg/30 mg (20 Liquid-Filled Capsules) LEADER TM NDC 70000-0606-1 Non-Drowsy Cold & Sinus Relief Ibuprofen 200 mg - Pain Reliever/Fever Reducer (NSAID) Pseudoephedrine HCl 30 mg - Nasal Decongestant Ibuprofen and Pseudoephedrine HCl Capsules 200 mg/30 mg Relieves Sinus Pressure Nasal Congestion and Fever 20 LIQUID-FILLED CAPSULES (2 X 10 Capsules per Blister Card) Actual Size COMPARE TO ADVIL ® COLD & SINUS active ingredients * 100% Money Back Guarantee PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 200 mg/30 mg (20 Liquid-Filled Capsules)

Overview

Uses temporarily relieves these symptoms associated with the common cold or flu: headache sinus pressure nasal congestion minor body aches and pains fever

Indications & Usage

Uses temporarily relieves these symptoms associated with the common cold or flu: headache sinus pressure nasal congestion minor body aches and pains fever

Dosage & Administration

Directions ● do not take more than directed ● the smallest effective dose should be used ● adults and children 12 years of age and over: ● take 1 capsule every 4 to 6 hours while symptoms persist. If symptoms do not respond to 1 capsule, 2 capsules may be used. ● do not use more than 6 capsules in any 24-hour period unless directed by a doctor ● children under 12 years of age: do not use Other information each capsule contains: potassium 20 mg store at 20° to 25°C (68° to 77°F). Avoid excessive heat above 40°C (104°F). read all warnings and directions before use. Keep carton.

Warnings & Precautions
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 Heart attack and stroke warning NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed.
Purpose

Purposes Pain reliever/fever reducer Nasal decongestant

Do Not Use

Do not use in children under 12 years of age if you have ever had an allergic reaction to any other pain reliever/fever reducer right before or after heart surgery 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.

When Using

When using this product take with food or milk if stomach upset occurs

Stop Use & Ask a Doctor

Stop use and ask a doctor if you experience any of the following signs of stomach bleeding: feel faint vomit blood have bloody or black stools have stomach pain that does not get better you have symptoms of heart problems or stroke: chest pain trouble breathing weakness in one part or side of body slurred speech leg swelling fever gets worse or lasts more than 3 days nasal congestion lasts for more than 7 days symptoms continue or get worse redness or swelling is present in the painful area you get nervous, dizzy, or sleepless any new symptoms appear

Keep Out of Reach of Children

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


Similar Drugs

Related medications based on brand, generic name, substance, active ingredients.

View all similar drugs →