ADVIL - ibuprofen capsule, liquid filled 
Pfizer Consumer Healthcare

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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

READ AND KEEP CARTON FOR COMPLETE WARNINGS AND INFORMATION

Do Not Use if seal under bottle cap imprinted with “SEALED for YOUR PROTECTION” is broken or missing.

For most recent product information, visit www.Advil.com

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 DRUGItem 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 GLYCOL 
POTASSIUM HYDROXIDE 
SORBITAN 
SORBITOL 
WATER 
Product Characteristics
ColorGREEN (Transparent green to blue green) Score no score
ShapeCAPSULE (oblong softgel) Size20mm
FlavorImprint Code Advil;on;one;side;in;white;ink
Contains    
Packaging
#Item CodePackage DescriptionMultilevel Packaging
1NDC:0573-0169-173000 POUCH ( POUCH) in 1 CASEcontains a POUCH
12 CAPSULE, LIQUID FILLED ( CAPSULE) in 1 POUCHThis package is contained within the CASE (0573-0169-17)
2NDC:0573-0169-0250 POUCH ( POUCH) in 1 BOXcontains a POUCH
22 CAPSULE, LIQUID FILLED ( CAPSULE) in 1 POUCHThis package is contained within the BOX (0573-0169-02)
3NDC:0573-0169-191 BLISTER PACK ( BLISTER PACK) in 1 CARTONcontains a BLISTER PACK
34 CAPSULE, LIQUID FILLED ( CAPSULE) in 1 BLISTER PACKThis package is contained within the CARTON (0573-0169-19)
4NDC:0573-0169-201 BOTTLE ( BOTTLE) in 1 CARTONcontains a BOTTLE
420 CAPSULE, LIQUID FILLED ( CAPSULE) in 1 BOTTLEThis package is contained within the CARTON (0573-0169-20)
5NDC:0573-0169-401 BOTTLE ( BOTTLE) in 1 CARTONcontains a BOTTLE
580 CAPSULE, LIQUID FILLED ( CAPSULE) in 1 BOTTLEThis package is contained within the CARTON (0573-0169-40)
6NDC:0573-0169-111 BOTTLE ( BOTTLE) in 1 CARTONcontains a BOTTLE
6120 CAPSULE, LIQUID FILLED ( CAPSULE) in 1 BOTTLEThis package is contained within the CARTON (0573-0169-11)
7NDC:0573-0169-891 BOTTLE ( BOTTLE) in 1 CARTONcontains a BOTTLE
7160 CAPSULE, LIQUID FILLED ( CAPSULE) in 1 BOTTLEThis package is contained within the CARTON (0573-0169-89)
8NDC:0573-0169-301 BOTTLE ( BOTTLE) in 1 CARTONcontains a BOTTLE
840 CAPSULE, LIQUID FILLED ( CAPSULE) in 1 BOTTLEThis package is contained within the CARTON (0573-0169-30)
9NDC:0573-0169-311 BOTTLE ( BOTTLE) in 1 CARTONcontains a BOTTLE
960 CAPSULE, LIQUID FILLED ( CAPSULE) in 1 BOTTLEThis package is contained within the CARTON (0573-0169-31)
10NDC:0573-0169-861 BOTTLE ( BOTTLE) in 1 CARTONcontains a BOTTLE
10100 CAPSULE, LIQUID FILLED ( CAPSULE) in 1 BOTTLEThis package is contained within the CARTON (0573-0169-86)
11NDC:0573-0169-511 BOTTLE ( BOTTLE) in 1 CARTONcontains a BOTTLE
11180 CAPSULE, LIQUID FILLED ( CAPSULE) in 1 BOTTLEThis package is contained within the CARTON (0573-0169-51)
12NDC:0573-0169-431 BOTTLE ( BOTTLE) in 1 CARTONcontains a BOTTLE
12120 CAPSULE, LIQUID FILLED ( CAPSULE) in 1 BOTTLEThis package is contained within the CARTON (0573-0169-43)
13NDC:0573-0169-52200 CAPSULE, LIQUID FILLED ( CAPSULE) in 1 BOTTLENone

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02040204/10/1995

Labeler - Pfizer Consumer Healthcare (828831730)
Establishment
NameAddressID/FEIOperations
Catalent Pharma Solutions, LLC051762268MANUFACTURE
Establishment
NameAddressID/FEIOperations
Catalent Argentina S.A.I.C.970545174MANUFACTURE

Revised: 08/2011 Pfizer Consumer Healthcare