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Advil Liqui-Gels

Generic Name: ibuprofen
Dosage Form: capsule, liquid filled

Advil Liqui-Gels (ibuprofen)

DRUG FACTS

ACTIVE INGREDIENT (IN EACH CAPSULE)

Solubilized ibuprofen equal to 200 mg ibuprofen (NSAID)*

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(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

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

See new warnings information

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.

Wyeth

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

Distributed by: Wyeth Consumer Healthcare

Madison, NJ 07940 USA ©2009 Wyeth

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

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 (ibuprofen) ibuprofen 200 mg
Product Characteristics
Color GREEN (Transparent green to blue green) Score no score
Shape CAPSULE (oblong softgel) Size 20mm
Flavor Imprint Code Advil;on;one;side;in;white;ink
Contains         
Packaging
# Item Code Package Description
1 NDC:0573-0169-17 3000 POUCH (POUCH) in 1 CASE
1 2 CAPSULE, LIQUID FILLED (CAPSULE) in 1 POUCH
2 NDC:0573-0169-02 50 POUCH (POUCH) in 1 BOX
2 2 CAPSULE, LIQUID FILLED (CAPSULE) in 1 POUCH
3 NDC:0573-0169-19 1 BLISTER PACK (BLISTER PACK) in 1 CARTON
3 4 CAPSULE, LIQUID FILLED (CAPSULE) in 1 BLISTER PACK
4 NDC:0573-0169-20 1 BOTTLE (BOTTLE) in 1 CARTON
4 20 CAPSULE, LIQUID FILLED (CAPSULE) in 1 BOTTLE
5 NDC:0573-0169-40 1 BOTTLE (BOTTLE) in 1 CARTON
5 80 CAPSULE, LIQUID FILLED (CAPSULE) in 1 BOTTLE
6 NDC:0573-0169-11 1 BOTTLE (BOTTLE) in 1 CARTON
6 120 CAPSULE, LIQUID FILLED (CAPSULE) in 1 BOTTLE
7 NDC:0573-0169-89 1 BOTTLE (BOTTLE) in 1 CARTON
7 160 CAPSULE, LIQUID FILLED (CAPSULE) in 1 BOTTLE
8 NDC:0573-0169-30 1 BOTTLE (BOTTLE) in 1 CARTON
8 40 CAPSULE, LIQUID FILLED (CAPSULE) in 1 BOTTLE
9 NDC:0573-0169-40 1 BOTTLE (BOTTLE) in 1 CARTON
9 80 CAPSULE, LIQUID FILLED (CAPSULE) in 1 BOTTLE
10 NDC:0573-0169-31 1 BOTTLE (BOTTLE) in 1 CARTON
10 60 CAPSULE, LIQUID FILLED (CAPSULE) in 1 BOTTLE
11 NDC:0573-0169-86 1 BOTTLE (BOTTLE) in 1 CARTON
11 100 CAPSULE, LIQUID FILLED (CAPSULE) in 1 BOTTLE
12 NDC:0573-0169-51 1 BOTTLE (BOTTLE) in 1 CARTON
12 180 CAPSULE, LIQUID FILLED (CAPSULE) in 1 BOTTLE
13 NDC:0573-0169-43 1 BOTTLE (BOTTLE) in 1 CARTON
13 120 CAPSULE, LIQUID FILLED (CAPSULE) in 1 BOTTLE
14 NDC:0573-0169-52 200 CAPSULE, LIQUID FILLED (CAPSULE) in 1 BOTTLE
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 Operations
Catalent Argentina S.A.I.C. 970545174 MANUFACTURE, ANALYSIS
Revised: 06/2010
 
Pfizer Consumer Healthcare



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