ADVIL- ibuprofen capsule, liquid filled

Advil by

Drug Labeling and Warnings

Advil by is a Otc medication manufactured, distributed, or labeled by GlaxoSmithKline Consumer Healthcare Holdings (US) LLC, Wyeth Pharmaceuticals Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DRUG FACTS

ACTIVE INGREDIENT (IN EACH CAPSULE)

Solubilized ibuprofen equal to 200 mg ibuprofen (NSAID)*

(present as the free acid and potassium salt)

*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 nonprescription 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 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

• do not take more than directed
• the smallest effective dose should be used
• adults and children 12 years and over: take 1 capsule every 4 to 6 hours while symptoms persist
• if pain or fever does not respond to 1 capsule, 2 capsules may be used
• do not exceed 6 capsules in 24 hours, unless directed by a doctor
• children under 12 years: ask a doctor

OTHER INFORMATION

• each capsule contains: potassium 20 mg
• 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 Liqui-Gels

FD&C green no. 3, gelatin, lecithin (soybean), medium-chain triglycerides, pharmaceutical ink, polyethylene glycol, potassium hydroxide, purified water, sorbitol sorbitan solution

Advil Liqui-Gels Minis

FD&C green no. 3, gelatin, medium-chain triglycerides, pharmaceutical ink, polyethylene glycol, potassium hydroxide, purified water, sorbitol sorbitan solution

QUESTIONS OR COMMENTS?

call toll free 1-800-88-ADVIL

PRINCIPAL DISPLAY PANEL - 200 mg Capsule Pouch

Advil®
LIQUI-GELS®

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

2 Liquid Filled Capsules

PRINCIPAL DISPLAY PANEL - 200 mg Capsule Pouch Box

Advil®
LIQUIGELS®

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

Liquid Filled
Capsules

PRINCIPAL DISPLAY PANEL - 40 Capsule Bottle Label

Advil®
LIQUIGELS®

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

40 Liquid Filled Capsules

READ AND KEEP CARTON FOR COMPLETE
WARNINGS AND INFORMATION

PRINCIPAL DISPLAY PANEL - 40 Capsule Bottle Carton

Advil®
LIQUIGELS®

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

40
Liquid Filled
Capsules

PRINCIPAL DISPLAY PANEL - 160 Capsule Bottle Label

Easy Open
ARTHRITIS CAP

Arthritis Foundation
Ease of
Use℠
CAP

THIS PACKAGE FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN

Advil®
LIQUIGELS®

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

160
Liquid Filled
Capsules

PRINCIPAL DISPLAY PANEL - 180 Capsule Bottle Label

20
FREE
LIQUIGELS®

Easy Open
ARTHRITIS CAP

Arthritis Foundation
Ease of
Use℠
CAP

THIS PACKAGE FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN

Advil®
LIQUIGELS®

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

180
Liquid Filled
Capsules

PRINCIPAL DISPLAY PANEL - 100 Capsule Bottle Label

Advil®
LIQUIGELS®

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

100 Liquid Filled Capsules

READ AND KEEP CARTON FOR COMPLETE
WARNINGS AND INFORMATION

PRINCIPAL DISPLAY PANEL - 100 Capsule Bottle Carton

Advil®
LIQUIGELS®

20
FREE
LIQUIGELS®

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

100
Liquid Filled Capsules

PRINCIPAL DISPLAY PANEL - 200 Capsule Bottle Label

GREAT VALUE!

Advil®
LIQUIGELS®

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

200
Liquid Filled
Capsules

PRINCIPAL DISPLAY PANEL - 120 Capsule Bottle Label

Advil®
LIQUIGELS®

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

120 Liquid Filled Capsules

READ AND KEEP CARTON FOR COMPLETE
WARNINGS AND INFORMATION

PRINCIPAL DISPLAY PANEL - 2 x 120 Capsule Bottle Carton

2
PACK
2x120 Count

Advil®
LIQUIGELS®

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

240
Liquid Filled
Capsules

2 x 120 Count Bottles

PRINCIPAL DISPLAY PANEL - 20 Capsule Bottle Label

Advil®
LIQUIGELS®

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

minis

20 Liquid Filled Capsules

PRINCIPAL DISPLAY PANEL - 20 Capsule Bottle Carton

Smaller
Capsule

Same
Strength*

Advil®
LIQUIGELS®

minis

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

20
Liquid Filled
Capsules

*Compared to Advil® Liqui-Gels®

PRINCIPAL DISPLAY PANEL - 240 Capsule Bottle Label

NEW
Smaller
Capsule

Same
Strength

Advil®
LIQUIGELS®

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

minis

240
Liquid Filled
Capsules

PRINCIPAL DISPLAY PANEL - 8 Capsule Vial Label

Advil®
LIQUIGELS®

minis

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

8
Liquid Filled
Capsules

PRINCIPAL DISPLAY PANEL - 8 Capsule Blister Pack - Short

Pocket Pack

Smaller
Capsule

Same
Strength*

Advil®
LIQUIGELS®

minis

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

8
Liquid Filled
Capsules

*Compared to Advil® Liqui-Gels®

Do not use if blister is open or the words "ADVIL SAFETY
SEALED" under blister are missing or torn.

READ AND KEEP CARD FOR COMPLETE
WARNINGS AND INFORMATION

PRINCIPAL DISPLAY PANEL - 8 Capsule Blister Pack - Large

Pocket Pack

Smaller
Capsule

Same
Strength*

Advil®
LIQUIGELS®

minis

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

Do not use if blister is open
or the words "ADVIL
SAFETY SEALED" under
blister are missing or torn.

8
Liquid Filled
Capsules

*Compared to Advil® Liqui-Gels®

INGREDIENTS AND APPEARANCE

ADVIL 
ibuprofen capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0573-0169
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM)	IBUPROFEN	200 mg

Inactive Ingredients
Ingredient Name	Strength
FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
WATER (UNII: 059QF0KO0R)
SORBITAN (UNII: 6O92ICV9RU)
SORBITOL (UNII: 506T60A25R)

Product Characteristics
Color	GREEN (Transparent green to blue green)	Score	no score
Shape	CAPSULE (oblong softgel)	Size	20mm
Flavor		Imprint Code	Advil
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0573-0169-17	3000 in 1 CASE	04/10/1995
1		2 in 1 POUCH; Type 0: Not a Combination Product
2	NDC: 0573-0169-02	50 in 1 BOX	04/10/1995
2		2 in 1 POUCH; Type 0: Not a Combination Product
3	NDC: 0573-0169-19	1 in 1 CARTON	04/10/1995
3		4 in 1 BLISTER PACK; Type 0: Not a Combination Product
4	NDC: 0573-0169-20	1 in 1 CARTON	04/10/1995
4		20 in 1 BOTTLE; Type 0: Not a Combination Product
5	NDC: 0573-0169-40	1 in 1 CARTON	04/10/1995
5		80 in 1 BOTTLE; Type 0: Not a Combination Product
6	NDC: 0573-0169-11	1 in 1 CARTON	04/10/1995
6		120 in 1 BOTTLE; Type 0: Not a Combination Product
7	NDC: 0573-0169-89	1 in 1 CARTON	04/10/1995
7		160 in 1 BOTTLE; Type 0: Not a Combination Product
8	NDC: 0573-0169-30	1 in 1 CARTON	04/10/1995
8		40 in 1 BOTTLE; Type 0: Not a Combination Product
9	NDC: 0573-0169-31	1 in 1 CARTON	04/10/1995
9		60 in 1 BOTTLE; Type 0: Not a Combination Product
10	NDC: 0573-0169-86	1 in 1 CARTON	04/10/1995
10		100 in 1 BOTTLE; Type 0: Not a Combination Product
11	NDC: 0573-0169-51	1 in 1 CARTON	04/10/1995
11		180 in 1 BOTTLE; Type 0: Not a Combination Product
12	NDC: 0573-0169-43	1 in 1 CARTON	04/10/1995
12		120 in 1 BOTTLE; Type 0: Not a Combination Product
13	NDC: 0573-0169-49	200 in 1 BOTTLE; Type 0: Not a Combination Product	04/10/1995
14	NDC: 0573-0169-52	1 in 1 CARTON	04/10/1995
14		200 in 1 BOTTLE; Type 0: Not a Combination Product
15	NDC: 0573-0169-08	2 in 1 CARTON	04/10/1995
15		120 in 1 BOTTLE; Type 0: Not a Combination Product
16	NDC: 0573-0169-22	1 in 1 CARTON	04/10/1995
16		30 in 1 BOTTLE; Type 0: Not a Combination Product
17	NDC: 0573-0169-13	240 in 1 BOTTLE; Type 0: Not a Combination Product	04/10/1995
18	NDC: 0573-0169-76	1 in 1 CARTON	04/10/1995
18		160 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA020402	04/10/1995

ADVIL 
ibuprofen capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0573-0149
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM)	IBUPROFEN	200 mg

Inactive Ingredients
Ingredient Name	Strength
FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
WATER (UNII: 059QF0KO0R)
SORBITAN (UNII: 6O92ICV9RU)
SORBITOL (UNII: 506T60A25R)

Product Characteristics
Color	GREEN (Transparent green to blue green)	Score	no score
Shape	CAPSULE (oblong softgel)	Size	20mm
Flavor		Imprint Code	Advil
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0573-0149-13	1 in 1 CARTON	04/10/1995
1		80 in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 0573-0149-04	2 in 1 BLISTER PACK	03/01/2018
2		2 in 1 PACKET; Type 0: Not a Combination Product
3	NDC: 0573-0149-66	160 in 1 BOTTLE; Type 0: Not a Combination Product	03/01/2016
4	NDC: 0573-0149-91	180 in 1 BOTTLE; Type 0: Not a Combination Product	10/01/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA020402	04/10/1995

ADVIL 
ibuprofen capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0573-1769
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM)	IBUPROFEN	200 mg

Inactive Ingredients
Ingredient Name	Strength
FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
SORBITAN (UNII: 6O92ICV9RU)

Product Characteristics
Color	GREEN (transparent green to blue green)	Score	no score
Shape	CAPSULE (oblong softgel)	Size	13mm
Flavor		Imprint Code	Advil
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0573-1769-20	1 in 1 CARTON	03/08/2017
1		20 in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 0573-1769-80	1 in 1 CARTON	03/08/2017
2		80 in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC: 0573-1769-89	1 in 1 CARTON	03/08/2017
3		160 in 1 BOTTLE; Type 0: Not a Combination Product
4	NDC: 0573-1769-14	240 in 1 BOTTLE; Type 0: Not a Combination Product	12/01/2018
5	NDC: 0573-1769-13	200 in 1 BOTTLE; Type 0: Not a Combination Product	06/01/2018
6	NDC: 0573-1769-09	1 in 1 BLISTER PACK	06/01/2018
6		8 in 1 VIAL; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA020402	03/08/2017

Labeler - Wyeth Consumer Healthcare LLC (828831730)

Establishment
Name	Address	ID/FEI	Business Operations
Wyeth Pharmaceuticals Company		829390975	ANALYSIS(0573-0149, 0573-0169, 0573-1769) , LABEL(0573-0149, 0573-0169, 0573-1769) , MANUFACTURE(0573-0149, 0573-0169, 0573-1769) , PACK(0573-0149, 0573-0169, 0573-1769)