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FDA > Advil Liqui-Gels

Advil Liqui-Gels

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Generic Name: ibuprofen
Dosage Form: liquid filled
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 a nonsteroidal anti-inflammatory drug (NSAID), which may cause 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 an NSAID [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 you have

  • problems or serious side effects from taking pain relievers or fever reducers
  • stomach problems that last or come back, such as heartburn, upset stomach, or stomach pain
  • ulcers
  • bleeding problems
  • high blood pressure
  • heart or kidney disease
  • asthma
  • taken a diuretic
  • reached age 60 or older

Ask a doctor or pharmacist before use if you are

  • taking any other drug containing an NSAID (prescription or nonprescription)
  • taking a blood thinning (anticoagulant) or steroid drug
  • 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 feel faint, vomit blood, or have bloody or black stools. These are signs of stomach bleeding.
  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days
  • stomach pain or upset gets worse or lasts
  • 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
  • do not take longer than 10 days, unless directed by a doctor (see WARNINGS)
  • 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

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: Wyeth Consumer Healthcare

Madison, NJ 07940 USA ©2008 Wyeth

U.S. Patent Nos. 5,071,643 and 5,360,615

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


ADVIL 
ibuprofen  capsule, liquid filled
Product Information
Product Type HUMAN OTC DRUG NDC Product Code (Source) 0573-0169
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ibuprofen (ibuprofen) ibuprofen 200 mg
Inactive Ingredients
Ingredient Name Strength
No Inactive Ingredients Found
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
# NDC Package Description Multilevel Packaging
1 0573-0169-17 3000 POUCH In 1 CASE contains a POUCH
1 2 CAPSULE In 1 POUCH This package is contained within the CASE (0573-0169-17)
2 0573-0169-02 50 POUCH In 1 BOX contains a POUCH
2 2 CAPSULE In 1 POUCH This package is contained within the BOX (0573-0169-02)
3 0573-0169-19 1 BLISTER PACK In 1 CARTON contains a BLISTER PACK
3 4 CAPSULE In 1 BLISTER PACK This package is contained within the CARTON (0573-0169-19)
4 0573-0169-20 1 BOTTLE In 1 CARTON contains a BOTTLE
4 20 CAPSULE In 1 BOTTLE This package is contained within the CARTON (0573-0169-20)
5 0573-0169-40 1 BOTTLE In 1 CARTON contains a BOTTLE
5 80 CAPSULE In 1 BOTTLE This package is contained within the CARTON (0573-0169-40)
6 0573-0169-11 1 BOTTLE In 1 CARTON contains a BOTTLE
6 120 CAPSULE In 1 BOTTLE This package is contained within the CARTON (0573-0169-11)
7 0573-0169-89 1 BOTTLE In 1 CARTON contains a BOTTLE
7 160 CAPSULE In 1 BOTTLE This package is contained within the CARTON (0573-0169-89)
8 0573-0169-30 1 BOTTLE In 1 CARTON contains a BOTTLE
8 40 CAPSULE In 1 BOTTLE This package is contained within the CARTON (0573-0169-30)

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

Labeler - Wyeth Consumer Healthcare (828831730)
Revised: 06/2009Wyeth Consumer Healthcare




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