ADVIL- ibuprofen capsule, liquid filled 
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC

----------

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 - 40 Capsule Bottle Carton

0573-0169-30

Advil®
LIQUI•GELS®

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

40
Liquid Filled
Capsules

PRINCIPAL DISPLAY PANEL - 40 Capsule Bottle Carton

PRINCIPAL DISPLAY PANEL - 160 Capsule Bottle Label

 
0573-0149-66

Easy Open
ARTHRITIS CAP

Arthritis Foundation
Ease of
Use℠
CAP

THIS PACKAGE FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN

Advil®
LIQUI•GELS®

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

160
Liquid Filled
Capsules

PRINCIPAL DISPLAY PANEL - 160 Capsule Bottle Label

PRINCIPAL DISPLAY PANEL - 20 Capsule Bottle Carton

0573-1769-20

Smaller
Capsule

Same
Strength*

Advil®
LIQUI•GELS®

minis

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

20
Liquid Filled
Capsules

*Compared to Advil® Liqui-Gels®

PRINCIPAL DISPLAY PANEL - 20 Capsule Bottle Carton
ADVIL 
ibuprofen capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0573-0169
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN200 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorGREEN (Transparent green to blue green) Scoreno score
ShapeCAPSULE (oblong softgel) Size20mm
FlavorImprint Code Advil
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0573-0169-173000 in 1 CASE04/10/1995
12 in 1 POUCH; Type 0: Not a Combination Product
2NDC:0573-0169-0250 in 1 BOX04/10/1995
22 in 1 POUCH; Type 0: Not a Combination Product
3NDC:0573-0169-191 in 1 CARTON04/10/1995
34 in 1 BLISTER PACK; Type 0: Not a Combination Product
4NDC:0573-0169-201 in 1 CARTON04/10/1995
420 in 1 BOTTLE; Type 0: Not a Combination Product
5NDC:0573-0169-401 in 1 CARTON04/10/1995
580 in 1 BOTTLE; Type 0: Not a Combination Product
6NDC:0573-0169-111 in 1 CARTON04/10/1995
6120 in 1 BOTTLE; Type 0: Not a Combination Product
7NDC:0573-0169-891 in 1 CARTON04/10/1995
7160 in 1 BOTTLE; Type 0: Not a Combination Product
8NDC:0573-0169-301 in 1 CARTON04/10/1995
840 in 1 BOTTLE; Type 0: Not a Combination Product
9NDC:0573-0169-311 in 1 CARTON04/10/1995
960 in 1 BOTTLE; Type 0: Not a Combination Product
10NDC:0573-0169-861 in 1 CARTON04/10/1995
10100 in 1 BOTTLE; Type 0: Not a Combination Product
11NDC:0573-0169-511 in 1 CARTON04/10/1995
11180 in 1 BOTTLE; Type 0: Not a Combination Product
12NDC:0573-0169-431 in 1 CARTON04/10/1995
12120 in 1 BOTTLE; Type 0: Not a Combination Product
13NDC:0573-0169-49200 in 1 BOTTLE; Type 0: Not a Combination Product04/10/1995
14NDC:0573-0169-521 in 1 CARTON04/10/1995
14200 in 1 BOTTLE; Type 0: Not a Combination Product
15NDC:0573-0169-082 in 1 CARTON04/10/1995
15120 in 1 BOTTLE; Type 0: Not a Combination Product
16NDC:0573-0169-221 in 1 CARTON04/10/1995
1630 in 1 BOTTLE; Type 0: Not a Combination Product
17NDC:0573-0169-13240 in 1 BOTTLE; Type 0: Not a Combination Product04/10/1995
18NDC:0573-0169-761 in 1 CARTON04/10/1995
18160 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02040204/10/1995
ADVIL 
ibuprofen capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0573-0149
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN200 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorGREEN (Transparent green to blue green) Scoreno score
ShapeCAPSULE (oblong softgel) Size20mm
FlavorImprint Code Advil
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0573-0149-131 in 1 CARTON04/10/1995
180 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:0573-0149-042 in 1 BLISTER PACK03/01/2018
22 in 1 PACKET; Type 0: Not a Combination Product
3NDC:0573-0149-66160 in 1 BOTTLE; Type 0: Not a Combination Product03/01/2016
4NDC:0573-0149-91180 in 1 BOTTLE; Type 0: Not a Combination Product10/01/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02040204/10/1995
ADVIL 
ibuprofen capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0573-1769
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN200 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorGREEN (transparent green to blue green) Scoreno score
ShapeCAPSULE (oblong softgel) Size13mm
FlavorImprint Code Advil
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0573-1769-201 in 1 CARTON03/08/2017
120 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:0573-1769-801 in 1 CARTON03/08/2017
280 in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:0573-1769-891 in 1 CARTON03/08/2017
3160 in 1 BOTTLE; Type 0: Not a Combination Product
4NDC:0573-1769-14240 in 1 BOTTLE; Type 0: Not a Combination Product12/01/2018
5NDC:0573-1769-13200 in 1 BOTTLE; Type 0: Not a Combination Product06/01/2018
6NDC:0573-1769-091 in 1 BLISTER PACK06/01/2018
68 in 1 VIAL; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02040203/08/2017
Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)
Establishment
NameAddressID/FEIBusiness Operations
Wyeth Pharmaceuticals Company829390975ANALYSIS(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)

Revised: 11/2020
Document Id: 4dc19bd8-7c6f-48d8-a358-02c0dcd5990a
Set id: 1f01c10a-9434-91a4-2ee4-352315a6b610
Version: 25
Effective Time: 20201110
 
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC