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Advil

Pfizer Consumer Healthcare

Advil Liqui-Gels (ibuprofen)


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

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

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

Advil

ibuprofen CAPSULE, LIQUID FILLED

Product Information

Product Type Human otc drug label Item Code (Source) NDC:0573-0169
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
IBUPROFEN IBUPROFEN 200 mg

Inactive Ingredients

Ingredient Name Strength
FD&C GREEN NO. 3
GELATIN
LIGHT MINERAL OIL
POLYETHYLENE GLYCOLS
POTASSIUM HYDROXIDE
SORBITAN
sorbitol
water

Product Characteristics

Color Size Imprint Code Shape
GREEN (Transparent green to blue green) 20 mm Advil CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 2 in 1 POUCH
2 2 in 1 POUCH
3 4 in 1 BLISTER PACK
4 20 in 1 BOTTLE
5 80 in 1 BOTTLE
6 120 in 1 BOTTLE
7 160 in 1 BOTTLE
8 40 in 1 BOTTLE
9 60 in 1 BOTTLE
10 100 in 1 BOTTLE
11 180 in 1 BOTTLE
12 120 in 1 BOTTLE
13 NDC:0573-0169-49 200 in 1 BOTTLE
14 200 in 1 BOTTLE
15 120 in 1 BOTTLE
16 30 in 1 BOTTLE
17 NDC:0573-0169-22 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020402 1995-04-10


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