Thursday 31 May 2012

Advil




Generic Name: ibuprofen

Dosage Form: caplets, tablets
Advil Caplets

Advil Gel Caplets

Advil Tablets

(ibuprofen)

DRUG FACTS



ACTIVE INGREDIENT



Advil Tablets (in each tablet)


Ibuprofen 200 mg (NSAID)*


*nonsteroidal anti-inflammatory drug



Advil Caplets (in each caplet)


Ibuprofen 200 mg (NSAID)*


*nonsteroidal anti-inflammatory drug



Advil Gel Caps (in each gel caplet)


Ibuprofen 200 mg (NSAID)*


*nonsteroidal anti-inflammatory drug



PURPOSE


Pain reliever/Fever reducer



USES


  • temporarily relieves minor aches and pains due to:
    • headache

    • toothache

    • backache

    • menstrual cramps

    • the common cold

    • muscular aches

    • minor pain of arthritis


  • temporarily reduces fever


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 non-prescription 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


Do not use


  • if you have 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 you

  • you have problems or serious side effects from taking pain relievers or fever reducers

  • you have a history of stomach problems, such as heartburn

  • you have high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma

  • you are taking a diuretic


Ask a doctor or pharmacist before use if you are


  • under a doctor’s care for any serious condition

  • taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin

  • 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


  • 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


  • pain gets worse or lasts more than 10 days

  • fever gets worse or lasts more than 3 days

  • redness or swelling is present in the painful area

  • any new symptoms appear


If pregnant or breast-feeding,


ask a health professional before use. It is especially important not to use ibuprofen during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.



Keep out of reach of children.


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



DIRECTIONS



Advil Tablets


  • do not take more than directed

  • the smallest effective dose should be used

  • adults and children 12 years of age and over: take 1 tablet every 4 to 6 hours while symptoms persist

  • if pain or fever does not respond to 1 tablet, 2 tablets may be used

  • do not exceed 6 tablets in 24 hours, unless directed by a doctor

  • children under 12 years: ask a doctor


Advil Caplets


  • do not take more than directed

  • the smallest effective dose should be used

  • adults and children 12 years of age and over: take 1 caplet every 4 to 6 hours while symptoms persist

  • if pain or fever does not respond to 1 caplet, 2 caplets may be used

  • do not exceed 6 caplets in 24 hours, unless directed by a doctor

  • children under 12 years: ask a doctor


Advil Gel Caplets


  • do not take more than directed

  • the smallest effective dose should be used

  • adults and children 12 years of age and over: take 1 gel caplet every 4 to 6 hours while symptoms persist

  • if pain or fever does not respond to 1 gel caplet, 2 gel caplets may be used

  • do not exceed 6 gel caplets in 24 hours, unless directed by a doctor

  • children under 12 years: ask a doctor


OTHER INFORMATION


  • read all warnings and directions before use. Keep carton.

  • store at 20-25°C (68-77°F)

  • avoid excessive heat above 40°C (104°F)


INACTIVE INGREDIENTS



Advil Tablets


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



Advil Caplets


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



Advil Gel Caplets


colloidal silicon dioxide, corn starch, croscarmellose sodium, FD&C red no. 40, FD&C yellow no. 6, fractionated coconut oil, gelatin, glycerin, hypromellose, pharmaceutical ink, pregelatinized starch, propyl gallate, purified water, sodium lauryl sulfate, stearic acid, synthetic iron oxides, titanium dioxide, triacetin



Questions or comments?


call toll-free 1-800-88-Advil



PRODUCT PACKAGING


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


Advil


Ibuprofen Tablets, 200 mg


Pain Reliever / Fever Reducer (NSAID)


100 Coated Tablets


See new warnings information


Read and Keep Carton for Complete Warnings and Information


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


Wyeth


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


Wyeth Consumer Healthcare, Madison, NJ 07940 USA


©2009 Wyeth U.S. Patent No. 5,087,454


Appearance of the brown Advil tablet is a trademark of Wyeth Consumer Healthcare










Advil 
ibuprofen  tablet, coated










Product Information
Product TypeHUMAN OTC DRUGNDC Product Code (Source)0573-0150
Route of AdministrationORALDEA Schedule    








Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Ibuprofen (Ibuprofen)Ibuprofen200 mg





Inactive Ingredients
Ingredient NameStrength
No Inactive Ingredients Found


















Product Characteristics
ColorBROWN (pinkish brown)Scoreno score
ShapeROUND (smooth in texture with polish surface)Size10mm
FlavorImprint CodeAdvil
Contains      


































































Packaging
#NDCPackage DescriptionMultilevel Packaging
10573-0150-201 BOTTLE In 1 CARTONcontains a BOTTLE
120 TABLET In 1 BOTTLEThis package is contained within the CARTON (0573-0150-20)
20573-0150-301 BOTTLE In 1 CARTONcontains a BOTTLE
250 TABLET In 1 BOTTLEThis package is contained within the CARTON (0573-0150-30)
30573-0150-401 BOTTLE In 1 CARTONcontains a BOTTLE
3100 TABLET In 1 BOTTLEThis package is contained within the CARTON (0573-0150-40)
40573-0150-311 BOTTLE In 1 CARTONcontains a BOTTLE
475 TABLET In 1 BOTTLEThis package is contained within the CARTON (0573-0150-31)
50573-0150-321 BOTTLE In 1 CARTONcontains a BOTTLE
560 TABLET In 1 BOTTLEThis package is contained within the CARTON (0573-0150-32)
60573-0150-411 BOTTLE In 1 CARTONcontains a BOTTLE
6125 TABLET In 1 BOTTLEThis package is contained within the CARTON (0573-0150-41)
70573-0150-421 BOTTLE In 1 CARTONcontains a BOTTLE
7150 TABLET In 1 BOTTLEThis package is contained within the CARTON (0573-0150-42)
80573-0150-48325 TABLET In 1 BOTTLENone










Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA01898905/18/1984







Advil 
ibuprofen  tablet, coated










Product Information
Product TypeHUMAN OTC DRUGNDC Product Code (Source)0573-0160
Route of AdministrationORALDEA Schedule    








Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ibuprofen (ibuprofen)ibuprofen200 mg





Inactive Ingredients
Ingredient NameStrength
No Inactive Ingredients Found


















Product Characteristics
ColorBROWN (pinkish brown)Scoreno score
ShapeOVAL (smooth in texture polished oval shaped tablet)Size15mm
FlavorImprint CodeAdvil
Contains      






























































Packaging
#NDCPackage DescriptionMultilevel Packaging
10573-0160-201 BOTTLE In 1 CARTONcontains a BOTTLE
124 TABLET In 1 BOTTLEThis package is contained within the CARTON (0573-0160-20)
20573-0160-301 BOTTLE In 1 CARTONcontains a BOTTLE
250 TABLET In 1 BOTTLEThis package is contained within the CARTON (0573-0160-30)
30573-0160-401 BOTTLE In 1 CARTONcontains a BOTTLE
3100 TABLET In 1 BOTTLEThis package is contained within the CARTON (0573-0160-40)
40573-0160-251 BOTTLE In 1 CARTONcontains a BOTTLE
436 TABLET In 1 BOTTLEThis package is contained within the CARTON (0573-0160-25)
50573-0160-311 BOTTLE In 1 CARTONcontains a BOTTLE
575 TABLET In 1 BOTTLEThis package is contained within the CARTON (0573-0160-31)
60573-0160-411 BOTTLE In 1 CARTONcontains a BOTTLE
6125 TABLET In 1 BOTTLEThis package is contained within the CARTON (0573-0160-41)
70573-0160-421 BOTTLE In 1 CARTONcontains a BOTTLE
7150 TABLET In 1 BOTTLEThis package is contained within the CARTON (0573-0160-42)










Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA01898905/18/1984







Advil 
ibuprofen  tablet, coated










Product Information
Product TypeHUMAN OTC DRUGNDC Product Code (Source)0573-0165
Route of AdministrationORALDEA Schedule    








Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ibuprofen (ibuprofen)ibuprofen200 mg





Inactive Ingredients
Ingredient NameStrength
No Inactive Ingredients Found


















Product Characteristics
ColorBROWN (one hemisphere is brown while the other hemisphere is yellow)Scoreno score
ShapeCAPSULE (smooth in texture with polished surface)Size16mm
FlavorImprint CodeAdvil
Contains      






















































Packaging
#NDCPackage DescriptionMultilevel Packaging
10573-0165-201 BOTTLE In 1 CARTONcontains a BOTTLE
124 TABLET In 1 BOTTLEThis package is contained within the CARTON (0573-0165-20)
20573-0165-301 BOTTLE In 1 CARTONcontains a BOTTLE
250 TABLET In 1 BOTTLEThis package is contained within the CARTON (0573-0165-30)
30573-0165-401 BOTTLE In 1 CARTONcontains a BOTTLE
3100 TABLET In 1 BOTTLEThis package is contained within the CARTON (0573-0165-40)
40573-0165-411 BOTTLE In 1 CARTONcontains a BOTTLE
4125 TABLET In 1 BOTTLEThis package is contained within the CARTON (0573-0165-41)
50573-0165-421 BOTTLE In 1 CARTONcontains a BOTTLE
5150 TABLET In 1 BOTTLEThis package is contained within the CARTON (0573-0165-42)
60573-0165-311 BOTTLE In 1 CARTONcontains a BOTTLE
675 TABLET In 1 BOTTLEThis package is contained within the CARTON (0573-0165-31)










Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA01898905/18/1984







Advil 
ibuprofen  tablet, coated










Product Information
Product TypeHUMAN OTC DRUGNDC Product Code (Source)0573-0154
Route of AdministrationORALDEA Schedule    








Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ibuprofen (ibuprofen)ibuprofen200 mg





Inactive Ingredients
Ingredient NameStrength
No Inactive Ingredients Found


















Product Characteristics
ColorBROWN (pinkish brown)Scoreno score
ShapeROUND (smooth in texture with polished surface)Size10mm
FlavorImprint CodeAdvil
Contains      














































Packaging
#NDCPackage DescriptionMultilevel Packaging
10573-0154-351 BOTTLE In 1 CARTONcontains a BOTTLE
1150 TABLET In 1 BOTTLEThis package is contained within the CARTON (0573-0154-35)
20573-0154-751 BOTTLE In 1 CARTONcontains a BOTTLE
2200 TABLET In 1 BOTTLEThis package is contained within the CARTON (0573-0154-75)
30573-0154-173000 POUCH In 1 CASEcontains a POUCH
32 TABLET In 1 POUCHThis package is contained within the CASE (0573-0154-17)
40573-0154-8950 POUCH In 1 CASEcontains a POUCH
42 TABLET In 1 POUCHThis package is contained within the CASE (0573-0154-89)
50573-0154-841 BOTTLE In 1 CARTONcontains a BOTTLE
5225 TABLET In 1 BOTTLEThis package is contained within the CARTON (0573-0154-84)










Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA01898905/18/1984







Advil 
ibuprofen  tablet, coated










Product Information
Product TypeHUMAN OTC DRUGNDC Product Code (Source)0573-0151
Route of AdministrationORALDEA Schedule    








Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ibuprofen (ibuprofen)ibuprofen200 mg





Inactive Ingredients
Ingredient NameStrength
No Inactive Ingredients Found


















Product Characteristics
ColorBROWN (pinkish brown )Scoreno score
ShapeROUND (smooth in texture with polished suface)Size10mm
FlavorImprint CodeAdvil
Contains      










































Packaging
#NDCPackage DescriptionMultilevel Packaging
10573-0151-1210 TABLET In 1 VIALNone
20573-0151-133 VIAL In 1 PACKAGEcontains a VIAL
210 TABLET In 1 VIALThis package is contained within the PACKAGE (0573-0151-13)
30573-0151-1010 VIAL In 1 PACKAGEcontains a VIAL
310 TABLET In 1 VIALThis package is contained within the PACKAGE (0573-0151-10)
40573-0151-211 BOTTLE In 1 CARTONcontains a BOTTLE
436 TABLET In 1 BOTTLEThis package is contained within the CARTON (0573-0151-21)
50573-0151-141 VIAL In 1 BLISTER PACKcontains a VIAL
510 TABLET In 1 VIALThis package is contained within the BLISTER PACK (0573-0151-14)










Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA01898905/18/1984







Advil 
ibuprofen  tablet, coated










Product Information
Product TypeHUMAN OTC DRUGNDC Product Code (Source)0573-0161
Route of AdministrationORALDEA Schedule    








Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ibuprofen (ibuprofen)ibuprofen200 mg





Inactive Ingredients
Ingredient NameStrength
No Inactive Ingredients Found


















Product Characteristics
ColorBROWN (pinkish brown)Scoreno score
ShapeOVAL (smooth in texture polished oval shaped tablet )Size15mm
FlavorImprint CodeAdvil
Contains      






























Packaging
#NDCPackage DescriptionMultilevel Packaging
10573-0161-351 BOTTLE In 1 CARTONcontains a BOTTLE
1150 TABLET In 1 BOTTLEThis package is contained within the CARTON (0573-0161-35)
20573-0161-511 BOTTLE In 1 CARTONcontains a BOTTLE
2200 TABLET In 1 BOTTLEThis package is contained within the CARTON (0573-0161-51)
30573-0161-851 BOTTLE In 1 CARTONcontains a BOTTLE
3225 TABLET In 1 BOTTLEThis package is contained within the CARTON (0573-0161-85)










Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA01898905/18/1984







Advil 
ibuprofen  tablet, coated










Product Information
Product TypeHUMAN OTC DRUGNDC Product Code (Source)0573-0166
Route of AdministrationORALDEA Schedule    








Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ibuprofen (ibuprofen)ibuprofen200 mg





Inactive Ingredients
Ingredient NameStrength
No Inactive Ingredients Found


















Product Characteristics
ColorBROWN (one hemisphere is brown while the other hemisphere is yellow)Scoreno score
ShapeCAPSULE (smooth in texture with polished surface)Size16mm
FlavorImprint CodeAdvil
Contains      


















Packaging
#NDCPackage DescriptionMultilevel Packaging
10573-0166-511 BOTTLE In 1 CARTONcontains a BOTTLE
1200 TABLET In 1 BOTTLEThis package is contained within the CARTON (0573-0166-51)
20573-0166-85225 TABLET In 1 BOTTLENone










Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA01898905/18/1984

Labeler - Pfizer Consumer Healthcar

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