ADVIL- ibuprofen tablet, coated 
Haleon US Holdings LLC

----------

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 Caplets (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

Heart attack and stroke warning:

NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer 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, asthma, or had a stroke
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

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
you have symptoms of heart problems or stroke:
chest pain
trouble breathing
weakness in one part or side of body
slurred speech
leg swelling
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 at 20 weeks or later in 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 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 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 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

PRINCIPAL DISPLAY PANEL – 100 Gel Caplet Bottle Carton

NDC 0573-0165-40

Advil

Ibuprofen Tablets, 200 mg
Pain Reliever / Fever Reducer (NSAID)

100 Coated Gel Caplets*
*Capsule-Shaped Gelatin-Coated Tablets

Gel
Caplets

000067202 Front Carton

Advil Gel Caps 100ct

PRINCIPAL DISPLAY PANEL - 300 Tablet Bottle Label

Advil®
Ibuprofen Tablets, 200 mg
Pain Reliever/Fever Reducer (NSAID)

300 Coated Tablets

Tablets

Advil Coated Tablets 300ct

PRINCIPAL DISPLAY PANEL - 115 Tablet Bottle Carton

15
FREE
TABLETS

Advil®
Ibuprofen Tablets, 200 mg
Pain Reliever/Fever Reducer (NSAID)

115
Coated Tablets

Tablets

Advil Coated Tablets 115

PRINCIPAL DISPLAY PANEL - 225 Caplet Bottle Carton

25
FREE
CAPLETS

Advil®
Ibuprofen Tablets, 200 mg
Pain Reliever/Fever Reducer (NSAID)

225
Coated Caplets*
*Capsule-Shaped Tablets

Caplets

Advil Coated Caplets 225 ct

PRINCIPAL DISPLAY PANEL - 24 Tablet Bottle Carton

NDC 0573-0150-20

Advil
Ibuprofen Tablets, 200 mg
Pain Reliever/Fever Reducer (NSAID)

24 Coated Tablets

Tablets

000067199 Front Carton

Advil Tablets 24ct

PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Label

Advil®
Ibuprofen Tablets, 200 mg
Pain Reliever/Fever Reducer (NSAID)

100 Tablets

Tablets

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.

Advil Tablets 100ct

PRINCIPAL DISPLAY PANEL - 24 Caplet Bottle Carton

NDC 0573-0160-20

Advil
Ibuprofen Tablets, 200 mg
Pain Reliever/Fever Reducer (NSAID)

24 Coated Caplets*
*Capsule-Shaped Tablets

Caplets

000067201 Front Carton

Advil Tablets Capsule Shaped  24ct

Principal Display Panel - 225 Caplet Bottle Label

NDC 0573-1711-14

Advil®
Ibuprofen Tablets, 200 mg
Pain Reliever/Fever Reducer (NSAID)

225 Caplets

Caplets

READ AND KEEP CARTON FOR COMPLETE
WARNINGS AND INFORMATION

PAA085439 Bottle Label

PAA085439 Advil Caplets 225 Caplets
ADVIL 
ibuprofen tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0573-0165
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN200 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
PROPYL GALLATE (UNII: 8D4SNN7V92)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
STARCH, CORN (UNII: O8232NY3SJ)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TRIACETIN (UNII: XHX3C3X673)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
ColorBROWN (one side is brown while the other side is yellow) Scoreno score
ShapeOVALSize16mm
FlavorImprint Code Advil
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0573-0165-201 in 1 CARTON05/18/1984
124 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:0573-0165-301 in 1 CARTON05/18/1984
250 in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:0573-0165-401 in 1 CARTON05/18/1984
3100 in 1 BOTTLE; Type 0: Not a Combination Product
4NDC:0573-0165-411 in 1 CARTON05/18/1984
4125 in 1 BOTTLE; Type 0: Not a Combination Product
5NDC:0573-0165-421 in 1 CARTON05/18/1984
5150 in 1 BOTTLE; Type 0: Not a Combination Product
6NDC:0573-0165-311 in 1 CARTON05/18/1984
675 in 1 BOTTLE; Type 0: Not a Combination Product
7NDC:0573-0165-251 in 1 CARTON05/18/1984
736 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA01898905/18/1984
ADVIL 
ibuprofen tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0573-0154
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN200 mg
Inactive Ingredients
Ingredient NameStrength
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
SHELLAC (UNII: 46N107B71O)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
STARCH, CORN (UNII: O8232NY3SJ)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
SUCROSE (UNII: C151H8M554)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
WHITE WAX (UNII: 7G1J5DA97F)  
DIACETYLATED MONOGLYCERIDES (UNII: 5Z17386USF)  
Product Characteristics
ColorBROWN (pinkish brown) Scoreno score
ShapeROUNDSize11mm
FlavorImprint Code Advil
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0573-0154-351 in 1 CARTON05/18/1984
1150 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:0573-0154-751 in 1 CARTON05/18/1984
2200 in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:0573-0154-173000 in 1 CASE05/18/1984
32 in 1 POUCH; Type 0: Not a Combination Product
4NDC:0573-0154-8950 in 1 CASE05/18/1984
42 in 1 POUCH; Type 0: Not a Combination Product
5NDC:0573-0154-841 in 1 CARTON05/18/1984
5225 in 1 BOTTLE; Type 0: Not a Combination Product
6NDC:0573-0154-98300 in 1 BOTTLE; Type 0: Not a Combination Product05/18/1984
7NDC:0573-0154-163 in 1 CARTON05/18/1984
72 in 1 POUCH; Type 0: Not a Combination Product
8NDC:0573-0154-60360 in 1 BOTTLE; Type 0: Not a Combination Product05/18/1984
9NDC:0573-0154-591 in 1 CARTON05/18/1984
9200 in 1 BOTTLE; Type 0: Not a Combination Product
10NDC:0573-0154-21200 in 1 BOTTLE; Type 0: Not a Combination Product01/04/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA01898905/18/1984
ADVIL 
ibuprofen tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0573-0151
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN200 mg
Inactive Ingredients
Ingredient NameStrength
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
SHELLAC (UNII: 46N107B71O)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
STARCH, CORN (UNII: O8232NY3SJ)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
SUCROSE (UNII: C151H8M554)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
WHITE WAX (UNII: 7G1J5DA97F)  
DIACETYLATED MONOGLYCERIDES (UNII: 5Z17386USF)  
Product Characteristics
ColorBROWN (pinkish brown) Scoreno score
ShapeROUNDSize11mm
FlavorImprint Code Advil
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0573-0151-1210 in 1 VIAL; Type 0: Not a Combination Product05/18/1984
2NDC:0573-0151-133 in 1 PACKAGE05/18/1984
210 in 1 VIAL; Type 0: Not a Combination Product
3NDC:0573-0151-1010 in 1 PACKAGE05/18/1984
310 in 1 VIAL; Type 0: Not a Combination Product
4NDC:0573-0151-211 in 1 CARTON05/18/1984
436 in 1 BOTTLE; Type 0: Not a Combination Product
5NDC:0573-0151-202 in 1 PACKAGE05/18/1984
510 in 1 VIAL; Type 0: Not a Combination Product
6NDC:0573-0151-482 in 1 PACKAGE05/18/1984
61 in 1 CARTON
6100 in 1 BOTTLE; Type 0: Not a Combination Product
7NDC:0573-0151-301 in 1 CARTON05/18/1984
7130 in 1 BOTTLE; Type 0: Not a Combination Product
8NDC:0573-0151-051 in 1 CARTON05/18/1984
8115 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA01898905/18/1984
ADVIL 
ibuprofen tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0573-0161
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN200 mg
Inactive Ingredients
Ingredient NameStrength
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
SHELLAC (UNII: 46N107B71O)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
STARCH, CORN (UNII: O8232NY3SJ)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
SUCROSE (UNII: C151H8M554)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
WHITE WAX (UNII: 7G1J5DA97F)  
DIACETYLATED MONOGLYCERIDES (UNII: 5Z17386USF)  
Product Characteristics
ColorBROWN (pinkish brown) Scoreno score
ShapeOVALSize15mm
FlavorImprint Code Advil
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0573-0161-351 in 1 CARTON05/18/1984
1150 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:0573-0161-511 in 1 CARTON05/18/1984
2200 in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:0573-0161-851 in 1 CARTON05/18/1984
3225 in 1 BOTTLE; Type 0: Not a Combination Product
4NDC:0573-0161-6565 in 1 BOTTLE; Type 0: Not a Combination Product05/01/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA01898905/18/1984
ADVIL 
ibuprofen tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0573-0166
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN200 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
PROPYL GALLATE (UNII: 8D4SNN7V92)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
STARCH, CORN (UNII: O8232NY3SJ)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TRIACETIN (UNII: XHX3C3X673)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
ColorBROWN (one side is brown while the other side is yellow) Scoreno score
ShapeOVALSize16mm
FlavorImprint Code Advil
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0573-0166-511 in 1 CARTON05/18/1984
1200 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:0573-0166-85225 in 1 BOTTLE; Type 0: Not a Combination Product05/18/1984
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA01898905/18/1984
ADVIL 
ibuprofen tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0573-0150
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN200 mg
Inactive Ingredients
Ingredient NameStrength
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
SHELLAC (UNII: 46N107B71O)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
STARCH, CORN (UNII: O8232NY3SJ)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
SUCROSE (UNII: C151H8M554)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
WHITE WAX (UNII: 7G1J5DA97F)  
DIACETYLATED MONOGLYCERIDES (UNII: 5Z17386USF)  
Product Characteristics
ColorBROWN (pinkish brown) Scoreno score
ShapeROUNDSize11mm
FlavorImprint Code Advil
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0573-0150-201 in 1 CARTON05/18/1984
124 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:0573-0150-301 in 1 CARTON05/18/1984
250 in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:0573-0150-401 in 1 CARTON05/18/1984
3100 in 1 BOTTLE; Type 0: Not a Combination Product
4NDC:0573-0150-311 in 1 CARTON05/18/1984
475 in 1 BOTTLE; Type 0: Not a Combination Product
5NDC:0573-0150-321 in 1 CARTON05/18/1984
560 in 1 BOTTLE; Type 0: Not a Combination Product
6NDC:0573-0150-411 in 1 CARTON05/18/1984
6125 in 1 BOTTLE; Type 0: Not a Combination Product
7NDC:0573-0150-421 in 1 CARTON05/18/1984
7150 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA01898905/18/1984
ADVIL 
ibuprofen tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0573-0160
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN200 mg
Inactive Ingredients
Ingredient NameStrength
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
SHELLAC (UNII: 46N107B71O)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
STARCH, CORN (UNII: O8232NY3SJ)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
SUCROSE (UNII: C151H8M554)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
WHITE WAX (UNII: 7G1J5DA97F)  
DIACETYLATED MONOGLYCERIDES (UNII: 5Z17386USF)  
Product Characteristics
ColorBROWN (pinkish brown) Scoreno score
ShapeOVALSize15mm
FlavorImprint Code Advil
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0573-0160-201 in 1 CARTON05/18/1984
124 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:0573-0160-301 in 1 CARTON05/18/1984
250 in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:0573-0160-401 in 1 CARTON05/18/1984
3100 in 1 BOTTLE; Type 0: Not a Combination Product
4NDC:0573-0160-251 in 1 CARTON05/18/1984
436 in 1 BOTTLE; Type 0: Not a Combination Product
5NDC:0573-0160-311 in 1 CARTON05/18/1984
575 in 1 BOTTLE; Type 0: Not a Combination Product
6NDC:0573-0160-411 in 1 CARTON05/18/1984
6125 in 1 BOTTLE; Type 0: Not a Combination Product
7NDC:0573-0160-421 in 1 CARTON05/18/1984
7150 in 1 BOTTLE; Type 0: Not a Combination Product
8NDC:0573-0160-171 in 1 CARTON05/18/1984
8115 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA01898905/18/1984
ADVIL 
ibuprofen tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0573-1711
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN200 mg
Inactive Ingredients
Ingredient NameStrength
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
SHELLAC (UNII: 46N107B71O)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
STARCH, CORN (UNII: O8232NY3SJ)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
SUCROSE (UNII: C151H8M554)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
WHITE WAX (UNII: 7G1J5DA97F)  
DIACETYLATED MONOGLYCERIDES (UNII: 5Z17386USF)  
Product Characteristics
ColorBROWN (pinkish brown) Scoreno score
ShapeROUNDSize11mm
FlavorImprint Code Advil
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0573-1711-141 in 1 CARTON05/18/1984
1225 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA01898905/18/1984
Labeler - Haleon US Holdings LLC (079944263)
Establishment
NameAddressID/FEIBusiness Operations
PF Consumer Healthcare B.V. (Puerto Rico Operations) LLC118346012ANALYSIS(0573-0150, 0573-0151, 0573-0154, 0573-0160, 0573-0161, 0573-0165, 0573-0166, 0573-1711) , LABEL(0573-0150, 0573-0151, 0573-0154, 0573-0160, 0573-0161, 0573-0165, 0573-0166, 0573-1711) , MANUFACTURE(0573-0150, 0573-0151, 0573-0154, 0573-0160, 0573-0161, 0573-0165, 0573-0166, 0573-1711) , PACK(0573-0150, 0573-0151, 0573-0154, 0573-0160, 0573-0161, 0573-0165, 0573-0166, 0573-1711)

Revised: 1/2024
Document Id: 48d4fbb4-f3ef-46a6-b8c2-171e37487c37
Set id: 1a665e64-9f30-be37-4a83-38789f1f1e89
Version: 35
Effective Time: 20240123
 
Haleon US Holdings LLC