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Name:Advil
Manufacturer:Lil' Drug Store Products, Inc.
Category:Over-the-counter (OTC) Marketed Drugs


Advil®

ADVIL - ibuprofen tablet, coated 
Lil' Drug Store Products, Inc.

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Advil®

Drug Facts

Active ingredient (in each tablet)

Ibuprofen 200 mg (NSAID)1


1
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 tablet every 4 to 6 hours while symptoms persist
  • if pain or fever does not respond to 1 tablet, 2 tablets may be used
  • do not exceed 6 tablets in 24 hours, unless directed by a doctor
  • children under 12 years: ask a doctor

Other information

  • 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

acetylated monoglycerides, colloidal silicon dioxide, corn starch, croscarmellose sodium, methylparaben, microcrystalline cellulose, pharmaceutical glaze, pharmaceutical ink, povidone, pregelatinized starch, propylparaben, sodium benzoate, sodium lauryl sulfate, stearic acid, sucrose, synthetic iron oxide, titanium dioxide, white wax

Questions or comments?

call toll free 1-800-88-ADVIL

Repackaged and distributed with permission of manufacturer by:
Lil' Drug Store Products, Inc., 1201 Continental Place NE, Cedar Rapids, IA 52402
www.lildrugstore.com

PRINCIPAL DISPLAY PANEL - 200 mg Tablet Carton

Advil®
Ibuprofen Tablets, 200 mg
Pain Reliever / Fever Reducer (NSAID)

Advil Tablets

See new warnings information

4
COATED
TABLETS

Lil'
Drug Store®

Principal Display Panel - 4 tablet carton

ADVIL 
ibuprofen tablet, coated
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:66715-9700(NDC:0573-0150)
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Ibuprofen (Ibuprofen) Ibuprofen 200 mg
Product Characteristics
Color BROWN (pinkish brown) Score no score
Shape ROUND (Smooth in texture w/ polish surface) Size 10mm
Flavor Imprint Code Advil
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:66715-9700-1 1 POUCH ( POUCH) in 1 CARTON contains a POUCH
1 2 TABLET, COATED ( TABLET) in 1 POUCH This package is contained within the CARTON (66715-9700-1)
2 NDC:66715-9700-2 2 POUCH ( POUCH) in 1 CARTON contains a POUCH
2 2 TABLET, COATED ( TABLET) in 1 POUCH This package is contained within the CARTON (66715-9700-2)
3 NDC:66715-9700-3 3 POUCH ( POUCH) in 1 CARTON contains a POUCH
3 2 TABLET, COATED ( TABLET) in 1 POUCH This package is contained within the CARTON (66715-9700-3)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA018989 02/22/2010

Labeler - Lil' Drug Store Products, Inc. (093103646)
Establishment
Name Address ID/FEI Operations
CCB Packaging Inc. 362374464 REPACK, RELABEL

Revised: 05/2010 Lil' Drug Store Products, Inc.



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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