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JUNIOR STRENGTH ADVIL(ibuprofen)tablet, coated
2014-08-16 09:40:55 来源: 作者: 【 】 浏览:430次 评论:0

DRUG FACTS

ACTIVE INGREDIENT (IN EACH TABLET)

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
  • 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
  • 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
Dosing Chart
Weight (lb) Age (yr) Dose (tablets)
under 48 lb under 6 yr ask a doctor
48-71 lb 6-10 yr 2 tablets
72-95 lb 11 yr 3 tablets

OTHER INFORMATION

  • one dose lasts 6-8 hours
  • store at 20-25°C (68-77°F)
  • avoid excessive heat above 40°C (104°F)
  • see side of box for lot number and expiration date

INACTIVE INGREDIENTS

acetylated monoglycerides, carnauba wax, colloidal silicon dioxide, corn starch, croscarmellose sodium, methylparaben, microcrystalline cellulose, pharmaceutical glaze, pharmaceutical ink, povidone, pregelatinized starch, propylparaben, sodium benzoate, stearic acid, sucrose, synthetic iron oxides, titanium dioxide

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.

Junior Strength Advil

Ibuprofen Tablets, 100 mg

Fever Reducer/Pain Reliever (NSAID)

Fever

Aches & Pains

Lasts Up To 8 Hours

For ages 6-11 years

24 Coated Tablets

Important: Read all product information before using. Keep this carton for important information. This product is intended for use in children ages 6 years – 11 years.

Do Not Use if seal under bottle cap imprinted with “SEALED for YOUR PROTECTION” is broken or missing.

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

Pfizer, Madison, NJ 07940 USA

© 2011 Pfizer Inc.

Junior Strength Advil Tablets Packaging
Junior Strength Advil Tablets Packaging

JUNIOR STRENGTH ADVIL
ibuprofen tablet, coated
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0573-0175
Route of Administration ORAL DEA Schedule  
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ibuprofen (ibuprofen) ibuprofen 100mg
Inactive Ingredients
Ingredient Name Strength
CARNAUBA WAX  
SILICON DIOXIDE  
STARCH, CORN  
CROSCARMELLOSE SODIUM  
METHYLPARABEN  
CELLULOSE, MICROCRYSTALLINE  
SHELLAC  
POVIDONE  
PROPYLPARABEN  
SODIUM BENZOATE  
STEARIC ACID  
SUCROSE  
TITANIUM DIOXIDE  
Product Characteristics
Color BROWN (tan) Score no score
Shape ROUND (round tablet) Size 8mm
Flavor   Imprint Code Advil;100
Contains  
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0573-0175-11 1 BOTTLE ( BOTTLE) in 1 CARTON contains a BOTTLE
1   24 TABLET, COATED ( TABLET) in 1 BOTTLE This package is contained within the CARTON(0573-0175-11)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020267 06/21/2011  

Labeler -Pfizer Consumer Healthcare (828831730)
Establishment
Name Address ID/FEI Operations
Wyeth Pharmaceuticals Company, Consumer Site   829390975 MANUFACTURE,ANALYSIS,LABEL,PACK 
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