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CHILDRENS ADVIL(ibuprofen) suspension
2014-08-16 09:38:26 来源: 作者: 【 】 浏览:320次 评论:0

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 lb under 2 yr ask a doctor
24-35 lb 2-3 yr 1 tsp
36-47 lb 4-5 yr 1½ tsp
48-59 lb 6-8 yr 2 tsp
60-71 lb 9-10 yr 2½ tsp
72-95 lb 11 yr 3 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.

Children's Advil Suspension Packaging

CHILDRENS ADVIL
ibuprofen suspension
Product Information
Product Type HUMAN OTC DRUG NDC Product Code (Source) 0573-0174
Route of Administration ORAL DEA Schedule  
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ibuprofen(ibuprofen) ibuprofen 100mg in5mL
Inactive Ingredients
Ingredient Name Strength
No Inactive Ingredients Found
Product Characteristics
Color BLUE (Translucent, medium dark blue) Score  
Shape   Size  
Flavor RASPBERRY Imprint Code  
Contains Sodium 10mg (Sodium 10mg)
Packaging
# NDC Package Description Multilevel Packaging
1 0573-0174-30 1BOTTLEIn1CARTON contains a BOTTLE
1   120mLIn1BOTTLE This package is contained within the CARTON(0573-0174-30)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020589 06/27/1996  

CHILDRENS ADVIL
ibuprofen suspension
Product Information
Product Type HUMAN OTC DRUG NDC Product Code (Source) 0573-0171
Route of Administration ORAL DEA Schedule  
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ibuprofen(ibuprofen) ibuprofen 100mg in5mL
Inactive Ingredients
Ingredient Name Strength
No Inactive Ingredients Found
Product Characteristics
Color PURPLE (Translucent purple) Score  
Shape   Size  
Flavor GRAPE Imprint Code  
Contains  
Packaging
# NDC Package Description Multilevel Packaging
1 0573-0171-30 1BOTTLEIn1CARTON contains a BOTTLE
1   120mLIn1BOTTLE This package is contained within the CARTON(0573-0171-30)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020589 06/27/1996  

CHILDRENS ADVIL
ibuprofen suspension
Product Information
Product Type HUMAN OTC DRUG NDC Product Code (Source) 0573-0170
Route of Administration ORAL DEA Schedule  
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ibuprofen(ibuprofen) ibuprofen 100mg in5mL
Inactive Ingredients
Ingredient Name Strength
No Inactive Ingredients Found
Product Characteristics
Color RED (Translucent red) Score  
Shape   Size  
Flavor FRUIT Imprint Code  
Contains  
Packaging
# NDC Package Description Multilevel Packaging
1 0573-0170-30 1BOTTLEIn1CARTON contains a BOTTLE
1   120mLIn1BOTTLE This package is contained within the CARTON(0573-0170-30)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020589 06/27/1996  

Labeler -Pfizer Consumer Healthcare(828831730)
Establishment
Name Address ID/FEI Operations
Richmond Division of Wyeth LLC, a subsidiary of Pfizer Inc.   829390827 MANUFACTURE,ANALYSIS 
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