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Advil by Pfizer Consumer Healthcare

Dosage form: capsule, liquid filled
Ingredients: IBUPROFEN 200mg
Labeler: Pfizer Consumer Healthcare
NDC Code: 0573-0169

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
  • 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

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
  • 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

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

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 
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 GLYCOLS 
POTASSIUM HYDROXIDE 
SORBITAN 
SORBITOL 
WATER 
Product Characteristics
ColorGREEN (Transparent green to blue green) Scoreno score
ShapeCAPSULE (oblong softgel) Size20mm
FlavorImprint CodeAdvil
Contains    
Packaging
#Item CodePackage Description
1NDC:0573-0169-173000 POUCH in 1 CASE
12 CAPSULE, LIQUID FILLED in 1 POUCH
2NDC:0573-0169-0250 POUCH in 1 BOX
22 CAPSULE, LIQUID FILLED in 1 POUCH
3NDC:0573-0169-191 BLISTER PACK in 1 CARTON
34 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
4NDC:0573-0169-201 BOTTLE in 1 CARTON
420 CAPSULE, LIQUID FILLED in 1 BOTTLE
5NDC:0573-0169-401 BOTTLE in 1 CARTON
580 CAPSULE, LIQUID FILLED in 1 BOTTLE
6NDC:0573-0169-111 BOTTLE in 1 CARTON
6120 CAPSULE, LIQUID FILLED in 1 BOTTLE
7NDC:0573-0169-891 BOTTLE in 1 CARTON
7160 CAPSULE, LIQUID FILLED in 1 BOTTLE
8NDC:0573-0169-301 BOTTLE in 1 CARTON
840 CAPSULE, LIQUID FILLED in 1 BOTTLE
9NDC:0573-0169-311 BOTTLE in 1 CARTON
960 CAPSULE, LIQUID FILLED in 1 BOTTLE
10NDC:0573-0169-861 BOTTLE in 1 CARTON
10100 CAPSULE, LIQUID FILLED in 1 BOTTLE
11NDC:0573-0169-511 BOTTLE in 1 CARTON
11180 CAPSULE, LIQUID FILLED in 1 BOTTLE
12NDC:0573-0169-431 BOTTLE in 1 CARTON
12120 CAPSULE, LIQUID FILLED in 1 BOTTLE
13NDC:0573-0169-49200 CAPSULE, LIQUID FILLED in 1 BOTTLE
14NDC:0573-0169-521 BOTTLE in 1 CARTON
14200 CAPSULE, LIQUID FILLED in 1 BOTTLE
15NDC:0573-0169-082 BOTTLE in 1 CARTON
15120 CAPSULE, LIQUID FILLED in 1 BOTTLE
16NDC:0573-0169-221 BOTTLE in 1 CARTON
1630 CAPSULE, LIQUID FILLED 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/FEIOperations
Wyeth Pharmaceuticals Company, Consumer Site829390975ANALYSIS(0573-0169), LABEL(0573-0169), MANUFACTURE(0573-0169), PACK(0573-0169)

Revised: 05/2014
 
Pfizer Consumer Healthcare

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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