ADVIL- ibuprofen capsule, liquid filled 
Pfizer Consumer Healthcare

----------

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

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

OTHER INFORMATION

INACTIVE INGREDIENTS

FD&C green no. 3, gelatin, light mineral oil, pharmaceutical ink, polyethylene glycol, potassium hydroxide, purified water, sorbitan, sorbitol

QUESTIONS OR COMMENTS?

call toll free 1-800-88-ADVIL

PRINCIPAL DISPLAY PANEL - 80 Capsule Bottle Label

Advil®
LIQUI-GELS®

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

80 Liquid Filled
Capsules

Liquid Filled
Capsules

READ AND KEEP CARTON FOR COMPLETE
WARNINGS AND INFORMATION

PRINCIPAL DISPLAY PANEL - 80 Capsule Bottle Label

PRODUCT PACKAGING

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

Advil Liqui-Gels

Solubilized Ibuprofen Capsules, 200 mg

Pain Reliever/Fever Reducer (NSAID)

80 Liqui-Gels* *Liquid Filled Capsules

Liquid Filled Capsules

Distributed by: Pfizer

Madison, NJ 07940 USA ©2011 Pfizer Inc.

LIQUI-GELS is a trademark or registered trademark of Catalent Pharma Solutions.

Advil Liqui-Gels Packaging
ADVIL 
ibuprofen capsule, liquid filled
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0573-0169
Route of Administration ORAL DEA Schedule     
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 (UNII: 2G86QN327L)  
LIGHT MINERAL OIL (UNII: N6K5787QVP)  
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
SORBITAN (UNII: 6O92ICV9RU)  
SORBITOL (UNII: 506T60A25R)  
WATER (UNII: 059QF0KO0R)  
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
1 2 in 1 POUCH; Type 0: Not a Combination Product
2 NDC:0573-0169-02 50 in 1 BOX
2 2 in 1 POUCH; Type 0: Not a Combination Product
3 NDC:0573-0169-19 1 in 1 CARTON
3 4 in 1 BLISTER PACK; Type 0: Not a Combination Product
4 NDC:0573-0169-20 1 in 1 CARTON
4 20 in 1 BOTTLE; Type 0: Not a Combination Product
5 NDC:0573-0169-40 1 in 1 CARTON
5 80 in 1 BOTTLE; Type 0: Not a Combination Product
6 NDC:0573-0169-11 1 in 1 CARTON
6 120 in 1 BOTTLE; Type 0: Not a Combination Product
7 NDC:0573-0169-89 1 in 1 CARTON
7 160 in 1 BOTTLE; Type 0: Not a Combination Product
8 NDC:0573-0169-30 1 in 1 CARTON
8 40 in 1 BOTTLE; Type 0: Not a Combination Product
9 NDC:0573-0169-31 1 in 1 CARTON
9 60 in 1 BOTTLE; Type 0: Not a Combination Product
10 NDC:0573-0169-86 1 in 1 CARTON
10 100 in 1 BOTTLE; Type 0: Not a Combination Product
11 NDC:0573-0169-51 1 in 1 CARTON
11 180 in 1 BOTTLE; Type 0: Not a Combination Product
12 NDC:0573-0169-43 1 in 1 CARTON
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
14 NDC:0573-0169-52 1 in 1 CARTON
14 200 in 1 BOTTLE; Type 0: Not a Combination Product
15 NDC:0573-0169-08 2 in 1 CARTON
15 120 in 1 BOTTLE; Type 0: Not a Combination Product
16 NDC:0573-0169-22 1 in 1 CARTON
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
18 NDC:0573-0169-76 1 in 1 CARTON
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 DEA Schedule     
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 (UNII: 2G86QN327L)  
LIGHT MINERAL OIL (UNII: N6K5787QVP)  
POLYETHYLENE GLYCOLS (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
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
Labeler - Pfizer Consumer Healthcare (828831730)
Establishment
Name Address ID/FEI Business Operations
Wyeth Pharmaceuticals Company, Consumer Site 829390975 ANALYSIS(0573-0149, 0573-0169) , LABEL(0573-0149, 0573-0169) , MANUFACTURE(0573-0149, 0573-0169) , PACK(0573-0149, 0573-0169)

Revised: 5/2015
Document Id: e7e97dde-915b-40c3-ba9c-f14846f65e3a
Set id: 1f01c10a-9434-91a4-2ee4-352315a6b610
Version: 9
Effective Time: 20150511
 
Pfizer Consumer Healthcare