ADVIL- ibuprofen capsule, liquid filled 
Pfizer Consumer Healthcare

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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

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

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 TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:0573-0169
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (IBUPROFEN) IBUPROFEN200 mg
Inactive Ingredients
Ingredient NameStrength
FD&C GREEN NO. 3 
GELATIN 
LIGHT MINERAL OIL 
POLYETHYLENE GLYCOLS 
POTASSIUM HYDROXIDE 
SORBITAN 
SORBITOL 
WATER 
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 CASE
12 in 1 POUCH
2NDC:0573-0169-0250 in 1 BOX
22 in 1 POUCH
3NDC:0573-0169-191 in 1 CARTON
34 in 1 BLISTER PACK
4NDC:0573-0169-201 in 1 CARTON
420 in 1 BOTTLE
5NDC:0573-0169-401 in 1 CARTON
580 in 1 BOTTLE
6NDC:0573-0169-111 in 1 CARTON
6120 in 1 BOTTLE
7NDC:0573-0169-891 in 1 CARTON
7160 in 1 BOTTLE
8NDC:0573-0169-301 in 1 CARTON
840 in 1 BOTTLE
9NDC:0573-0169-311 in 1 CARTON
960 in 1 BOTTLE
10NDC:0573-0169-861 in 1 CARTON
10100 in 1 BOTTLE
11NDC:0573-0169-511 in 1 CARTON
11180 in 1 BOTTLE
12NDC:0573-0169-431 in 1 CARTON
12120 in 1 BOTTLE
13NDC:0573-0169-49200 in 1 BOTTLE
14NDC:0573-0169-521 in 1 CARTON
14200 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02040204/10/1995
Labeler - Pfizer Consumer Healthcare (828831730)
Establishment
NameAddressID/FEIBusiness Operations
Catalent Pharma Solutions, LLC051762268ANALYSIS(0573-0169), MANUFACTURE(0573-0169), PACK(0573-0169), REPACK(0573-0169)
Establishment
NameAddressID/FEIBusiness Operations
Catalent Argentina S.A.I.C.970545174MANUFACTURE(0573-0169)
Establishment
NameAddressID/FEIBusiness Operations
Fareva Richmond, Inc.969523245ANALYSIS(0573-0169), LABEL(0573-0169), MANUFACTURE(0573-0169), PACK(0573-0169), RELABEL(0573-0169), REPACK(0573-0169)
Establishment
NameAddressID/FEIBusiness Operations
Wyeth Pharmaceuticals Company, Consumer Site829390975ANALYSIS(0573-0169), LABEL(0573-0169), MANUFACTURE(0573-0169), PACK(0573-0169)

Revised: 10/2012
Document Id: 88406298-2b7a-43bd-8904-7410f491a825
Set id: 1f01c10a-9434-91a4-2ee4-352315a6b610
Version: 5
Effective Time: 20121022
 
Pfizer Consumer Healthcare