ADVIL- ibuprofen capsule, liquid filled 
Wyeth Consumer Healthcare LLC

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Advil Liqui-Gels (ibuprofen)

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

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

OTHER INFORMATION

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

PRINCIPAL DISPLAY PANEL - 200 mg Capsule Pouch Box

Advil®
LIQUI•GELS®

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

Liquid Filled
Capsules

PRINCIPAL DISPLAY PANEL - 200 mg Capsule Pouch Box

PRINCIPAL DISPLAY PANEL - 80 Capsule Bottle Label

Advil®
LIQUI-GELS®

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

80 Liquid Filled Capsules

READ AND KEEP CARTON FOR COMPLETE
WARNINGS AND INFORMATION

PRINCIPAL DISPLAY PANEL - 80 Capsule Bottle Label

PRINCIPAL DISPLAY PANEL - 80 Capsule Bottle Carton

Advil®
LIQUI•GELS®

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

80
Liquid Filled
Capsules

PRINCIPAL DISPLAY PANEL - 80 Capsule Bottle Carton

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®
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 Label

Advil®
LIQUI•GELS®

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

minis

20 Liquid Filled Capsules

PRINCIPAL DISPLAY PANEL - 20 Capsule Bottle Label

PRINCIPAL DISPLAY PANEL - 20 Capsule Bottle Carton

NEW
Smaller
Capsule

Same
Strength

Advil®
LIQUI•GELS®

minis

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

20
Liquid Filled
Capsules

PRINCIPAL DISPLAY PANEL - 20 Capsule Bottle Carton
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
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
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)

Revised: 8/2017
Document Id: 5abb3d89-eed1-49b0-b8de-97171a47e610
Set id: 1f01c10a-9434-91a4-2ee4-352315a6b610
Version: 14
Effective Time: 20170802
 
Wyeth Consumer Healthcare LLC