Drug Notebook

FDA Alerts

Special Alerts:

[Posted 01/17/2008] FDA informed consumers and healthcare professionals that the Agency has completed its review of information regarding the safety of over-the-counter (OTC) cough and cold medicines in children under 2 years of age and recommends that these drugs not be used to treat children in this age group because serious and potentially life-threatening side effects can occur. FDA's recommendation is based on both the review of the information the Agency received about serious side effects in children in the referenced age group and the discussion and recommendations made at the October 18 -19, 2007, public advisory committee meeting at which this issue was discussed. FDA has not completed its review of information about the safety of OTC cough and cold medicines in children 2 through 11 years of age. See the FDA Public Health Advisory for Agency recommendations regarding this issue. For more information visit the FDA website at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#cough and http://www.fda.gov/cder/drug/advisory/cough_cold_2008.htm.

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ibuprofen
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(eye byoo PROE fen)

Preparations

In response to concerns regarding the safety and efficacy of cough/cold preparations in young children, many OTC cough/cold preparations specifically formulated for infants have been voluntarily withdrawn from the US market. Therefore, some of the preparations described below may no longer be commercially available in the US.

Ibuprofen
RoutesDosage FormsStrengthsBrand NamesManufacturer
OralCapsules, liquid-filled200 mg

Advil® Liqui-Gels®

Wyeth
equivalent to 200 mg ibuprofen (as free acid and ibuprofen potassium)

Advil® Migraine®

Wyeth
Suspension40 mg/mL*

Advil® Infants’ Concentrated Drops

Wyeth

Motrin® Drops

McNeil

Motrin® Infants’ Concentrated Drops

McNeil
100 mg/5 mL*

Advil® Children’s

Wyeth

Ibuprofen Oral Suspension

Actavis, Par

Motrin® Children’s

McNeil
Tablets200 mg*

Motrin® IB Gelcaps® (with benzyl alcohol, parabens, povidone)

McNeil
400 mg*
600 mg*
800 mg*
Tablets, chewable50 mg

Advil® Children’s (with aspartame)

Wyeth

Motrin® Children’s (with aspartame and povidone)

McNeil
100 mg

Advil® Junior Strength Chewable Tablets (with aspartame)

Wyeth

Motrin® (with aspartame and povidone; scored)

McNeil

Motrin® Junior Strength (with aspartame and povidone)

McNeil
Tablets, film-coated100 mg

Advil® Junior Strength Tablets (with parabens, povidone, and propylene glycol)

Wyeth

Motrin® Caplets® (with propylene glycol; scored)

McNeil

Motrin® Junior Strength Caplets® (with propylene glycol)

McNeil
200 mg*

Advil® Caplets® (with parabens and povidone)

Wyeth

Advil® Gel Caplets

Wyeth

Advil® Tablets (with parabens and povidone)

Wyeth

Genpril® Caplets ®

Teva

Genpril® Tablets

Teva

Haltran® (with propylene glycol)

Lee

Ibu-Tab®

Alra

Menadol® Captabs®

Watson

Midol® Cramp

Bayer

Motrin® IB Caplets®

McNeil

Motrin® IB Tablets

McNeil

Motrin® Migraine Pain Caplets® (with propylene glycol)

McNeil
400 mg*

IBU®

Par

Ibu-Tab®

Alra

Motrin® (with propylene glycol)

Pharmacia
600 mg*

IBU®

Par

Ibu-Tab®

Alra

Motrin® (with propylene glycol)

Pharmacia
800 mg*

IBU®

Par

Ibu-Tab®

Alra

Motrin® (with propylene glycol)

Pharmacia
* available generically
Ibuprofen Combinations
RoutesDosage FormsStrengthsBrand NamesManufacturer
OralSuspension
100 mg with Pseudoephedrine Hydrochloride 15 mg/5 mL

Motrin® Children’s Cold

McNeil
Tablets200 mg with Hydrocodone Bitartrate 7.5 mg

Vicoprofen® ( C-III)

Abbott
200 mg with Pseudoephedrine Hydrochloride 30 mg

Dristan® Sinus Caplets® (with parabens)

Wyeth
Tablets, film-coated200 mg with Pseudoephedrine Hydrochloride 30 mg

Advil® Cold & Sinus® Caplets® (with parabens)

Wyeth

Advil® Cold & Sinus Tablets (with parabens)

Wyeth

Advil® Flu & Body Ache Caplets® (with parabens)

Wyeth

Motrin® Sinus Headache Caplets®

McNeil
Ibuprofen Lysine
RoutesDosage FormsStrengthsBrand NamesManufacturer
ParenteralFor injection, for IV use only10 mg/mL(of ibuprofen)

NeoProfen®

Ovation

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.

Combunox 5-400MG Tablets FOREST20/$39.51 or 30/$59.27
Hydrocodone-Ibuprofen 7.5-200MG Tablets ANDRX PHARMACEUTICALS30/$29.99 or 90/$82.97
Ibuprofen 100MG/5ML Suspension ACTAVIS MID ATLANTIC473/$24.27 or 1419/$72.8
Ibuprofen 400MG Tablets INTERPHARM90/$14 or 180/$18
Ibuprofen 600MG Tablets INTERPHARM90/$14.99 or 180/$21.98
Motrin 600MG Tablets PFIZER U.S.30/$18.69 or 60/$28.58
Oxycodone-Ibuprofen 5-400MG Tablets WATSON LABS20/$33.33 or 30/$49.99
Reprexain 5-200MG Tablets WATSON LABS30/$39.99 or 90/$112.97
Vicoprofen 7.5-200MG Tablets ABBOTT30/$71.28 or 90/$192.02

AHFS Drug Information. © Copyright, 1959-2008, Selected Revisions March 2008. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

† Use is not currently included in the labeling approved by the US Food and Drug Administration.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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