Saturday 8 September 2012

Advil Childrens



ibuprofen

Dosage Form: suspension
CHILDREN’S ADVIL SUSPENSION (ibuprofen)

DRUG FACTS



ACTIVE INGREDIENT (IN EACH 5 ML)


Ibuprofen 100 mg (NSAID)*


*nonsteroidal anti-inflammatory drug



PURPOSE


Fever reducer/Pain reliever



USES


temporarily:


  • reduces fever

  • relieves minor aches and pains due to the common cold, flu, sore throat, headaches and toothaches


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 the child


  • has had stomach ulcers or bleeding problems

  • takes a blood thinning (anticoagulant) or steroid drug

  • takes other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]

  • takes more or for a longer time than directed


Sore throat warning:


Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult doctor promptly. Do not use more than 2 days or administer to children under 3 years of age unless directed by doctor.



Do not use


  • if the child has ever had an allergic reaction to any other pain reliever/fever reducer

  • right before or after heart surgery


Ask a doctor before use if


  • stomach bleeding warning applies to the child

  • child has problems or serious side effects from taking pain relievers or fever reducers

  • child has a history of stomach problems, such as heartburn

  • child has high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma

  • child has not been drinking fluids

  • child has lost a lot of fluid due to vomiting or diarrhea

  • child is taking a diuretic


Ask a doctor or pharmacist before use if the child is


  • under a doctor’s care for any serious condition

  • taking any other drug


When using this product


  • take with food or milk if stomach upset occurs

  • the risk of heart attack or stroke may increase if you use more than directed or for longer than directed


Stop use and ask a doctor if


  • child experiences any of the following signs of stomach bleeding:
    • feels faint

    • vomits blood

    • has bloody or black stools

    • has stomach pain that does not get better


  • the child does not get any relief within first day (24 hours) of treatment

  • fever or pain gets worse or lasts more than 3 days

  • redness or swelling is present in the painful area

  • any new symptoms appear


Keep out of reach of children.


In case of overdose, get medical help or contact a Poison Control Center right away.



DIRECTIONS


  • this product does not contain directions or complete warnings for adult use

  • do not give more than directed

  • shake well before using

  • find right dose on chart below. If possible, use weight to dose; otherwise use age.

  • repeat dose every 6-8 hours, if needed

  • do not use more than 4 times a day

  • measure only with the dosing cup provided. Dosing cup to be used with Children’s Advil Suspension only. Do not use with other products. Dose lines account for product remaining in cup due to thickness of suspension.

Dosing Chart
























Weight (lb)Age (yr)Dose (tsp)
under 24 lbunder 2 yrask a doctor
24-35 lb2-3 yr1 tsp
36-47 lb4-5 yr1½ tsp
48-59 lb6-8 yr2 tsp
60-71 lb9-10 yr2½ tsp
72-95 lb11 yr3 tsp

OTHER INFORMATION



Children’s Advil Suspension Fruit Flavor; Children’s Advil Suspension Grape Flavor


  • each teaspoon contains: sodium 3 mg

  • one dose lasts 6-8 hours

  • store at 20-25°C (68-77°F)

  • see bottom of box for lot number and expiration date


Children’s Advil Suspension Blue Raspberry Flavor


  • each teaspoon contains: sodium 10 mg

  • one dose lasts 6-8 hours

  • store at 20-25°C (68-77°F)

  • see bottom of box for lot number and expiration date


INACTIVE INGREDIENTS



Children’s Advil Suspension Fruit Flavor


artificial flavors, carboxymethylcellulose sodium, citric acid monohydrate, edetate disodium, FD&C red no. 40, glycerin, microcrystalline cellulose, polysorbate 80, purified water, sodium benzoate, sorbitol solution, sucrose, xanthan gum



Children’s Advil Suspension Grape Flavor


acetic acid, artificial flavor, butylated hydroxytoluene, carboxymethylcellulose sodium, citric acid monohydrate, edetate disodium, FD&C blue no.1, FD&C red no. 40, glycerin, microcrystalline cellulose, polysorbate 80, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucrose, xanthan gum



Children’s Advil Suspension Blue Raspberry Flavor


artificial and natural flavors, carboxymethylcellulose sodium, citric acid monohydrate, edetate disodium, FD&C blue no. 1, glycerin, microcrystalline cellulose, polysorbate 80, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucrose, xanthan gum



QUESTIONS OR COMMENTS?


call toll-free 1-800-88-ADVIL or ask your pharmacist, doctor or health care professional



PRODUCT PACKAGING


The product packaging shown below represents a sample of that currently in use. Additional packaging may also be available.


See new warnings information


Children’s Advil Suspension


Ibuprofen 100 mg Fever Reducer/Pain Reliever (NSAID) per 5 mL


Fever


Aches & Pains


Lasts Up To 8 Hours


Fruit-Flavored Liquid for ages 2-11 years


4 FL OZ (120 mL)


Important: Read all product information before using. Keep this box for important information. This product is intended for use in children ages 2 years-11 years.


Long Lasting: Up to 8 hours of fever reduction


Great Convenience: Long duration means fewer doses needed per day.


Wyeth


For most recent product information, visit www.Advil.com.


Wyeth Consumer Healthcare


Madison, NJ 07940 USA ©2009 Wyeth


Packaged with Tamper-Evident bottle cap. Do Not Use if breakable ring is separated or missing.










CHILDRENS ADVIL 
ibuprofen  suspension










Product Information
Product TypeHUMAN OTC DRUGNDC Product Code (Source)0573-0174
Route of AdministrationORALDEA Schedule    








Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ibuprofen (ibuprofen)ibuprofen100 mg  in 5 mL





Inactive Ingredients
Ingredient NameStrength
No Inactive Ingredients Found


















Product Characteristics
ColorBLUE (Translucent, medium dark blue)Score    
ShapeSize
FlavorRASPBERRYImprint Code
ContainsSodium 10mg (Sodium 10mg)  














Packaging
#NDCPackage DescriptionMultilevel Packaging
10573-0174-301 BOTTLE In 1 CARTONcontains a BOTTLE
1120 mL In 1 BOTTLEThis package is contained within the CARTON (0573-0174-30)










Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02058906/27/1996







CHILDRENS ADVIL 
ibuprofen  suspension










Product Information
Product TypeHUMAN OTC DRUGNDC Product Code (Source)0573-0171
Route of AdministrationORALDEA Schedule    








Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ibuprofen (ibuprofen)ibuprofen100 mg  in 5 mL





Inactive Ingredients
Ingredient NameStrength
No Inactive Ingredients Found


















Product Characteristics
ColorPURPLE (Translucent purple)Score    
ShapeSize
FlavorGRAPEImprint Code
Contains      














Packaging
#NDCPackage DescriptionMultilevel Packaging
10573-0171-301 BOTTLE In 1 CARTONcontains a BOTTLE
1120 mL In 1 BOTTLEThis package is contained within the CARTON (0573-0171-30)










Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02058906/27/1996







CHILDRENS ADVIL 
ibuprofen  suspension










Product Information
Product TypeHUMAN OTC DRUGNDC Product Code (Source)0573-0170
Route of AdministrationORALDEA Schedule    








Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ibuprofen (ibuprofen)ibuprofen100 mg  in 5 mL





Inactive Ingredients
Ingredient NameStrength
No Inactive Ingredients Found


















Product Characteristics
ColorRED (Translucent red)Score    
ShapeSize
FlavorFRUITImprint Code
Contains      














Packaging
#NDCPackage DescriptionMultilevel Packaging
10573-0170-301 BOTTLE In 1 CARTONcontains a BOTTLE
1120 mL In 1 BOTTLEThis package is contained within the CARTON (0573-0170-30)










Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02058906/27/1996


Labeler - Pfizer Consumer Healthcare (828831730)









Establishment
NameAddressID/FEIOperations
Richmond Division of Wyeth LLC, a subsidiary of Pfizer Inc.829390827MANUFACTURE, ANALYSIS
Revised: 06/2010Pfizer Consumer Healthcare




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