NDC 0573-0160 Advil
Ibuprofen Tablet, Coated Oral

Product Information

Advil is a human over the counter drug product labeled by Glaxosmithkline Consumer Healthcare Holdings (us) Llc. The generic name of Advil is ibuprofen. The product's dosage form is tablet, coated and is administered via oral form.

Product Code0573-0160
Proprietary Name What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Advil
Non-Proprietary Name What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
Ibuprofen
Product Type What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
Human Otc Drug
Dosage FormTablet, Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is covered with a designated coating.
Administration Route(s) What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.
  • Oral - Administration to or by way of the mouth.
Product Labeler Information What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.
Glaxosmithkline Consumer Healthcare Holdings (us) Llc
Labeler Code0573
FDA Application Number What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
NDA018989
Marketing Category What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
05-18-1984
Listing Expiration Date What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.
12-31-2023
Exclude Flag What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".
N
NDC Code Structure

What are the uses for Advil?


Product Characteristics

Color(s)BROWN (C48332 - ONE SIDE IS BROWN WHILE THE OTHER SIDE IS YELLOW)
BROWN (C48332 - PINKISH BROWN)
ShapeOVAL (C48345)
ROUND (C48348)
Size(s)16 MM
11 MM
15 MM
Imprint(s)ADVIL
Score1

Product Packages

NDC 0573-0160-17

Package Description: 1 BOTTLE in 1 CARTON > 115 TABLET, COATED in 1 BOTTLE

NDC 0573-0160-20

Package Description: 1 BOTTLE in 1 CARTON > 24 TABLET, COATED in 1 BOTTLE

Price per Unit: $0.10809 per EA

NDC 0573-0160-25

Package Description: 1 BOTTLE in 1 CARTON > 36 TABLET, COATED in 1 BOTTLE

NDC 0573-0160-30

Package Description: 1 BOTTLE in 1 CARTON > 50 TABLET, COATED in 1 BOTTLE

Price per Unit: $0.10809 per EA

NDC 0573-0160-31

Package Description: 1 BOTTLE in 1 CARTON > 75 TABLET, COATED in 1 BOTTLE

NDC 0573-0160-40

Package Description: 1 BOTTLE in 1 CARTON > 100 TABLET, COATED in 1 BOTTLE

Price per Unit: $0.10809 per EA

NDC 0573-0160-41

Package Description: 1 BOTTLE in 1 CARTON > 125 TABLET, COATED in 1 BOTTLE

NDC 0573-0160-42

Package Description: 1 BOTTLE in 1 CARTON > 150 TABLET, COATED in 1 BOTTLE

Product Details

What are Advil Active Ingredients?

An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
  • IBUPROFEN 200 mg/1 - A nonsteroidal anti-inflammatory agent with analgesic properties used in the treatment of RHEUMATISM and ARTHRITIS.

Advil Active Ingredients UNII Codes

NDC to RxNorm Crosswalk

What is RxNorm? RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:

Advil Inactive Ingredients UNII Codes

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

Pharmacologic Class(es)

A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

* Please review the disclaimer below.

Patient Education

Ibuprofen

Ibuprofen is pronounced as (eye byoo' proe fen)

Why is ibuprofen medication prescribed?
Prescription ibuprofen is used to relieve pain, tenderness, swelling, and stiffness caused by osteoarthritis (arthritis caused by a breakdown of the lining of the joints)...
[Read More]

* Please review the disclaimer below.

Advil Labeling and Warnings

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Table of Contents



Advil Tablets (In Each Tablet)



Ibuprofen 200 mg (NSAID)*

*nonsteroidal anti-inflammatory drug


Advil Caplets (In Each Caplet)



Ibuprofen 200 mg (NSAID)*

*nonsteroidal anti-inflammatory drug


Advil Gel Caplets (In Each Gel Caplet)



Ibuprofen 200 mg (NSAID)*

*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

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 non-prescription 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

Heart Attack And Stroke Warning



NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer 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, asthma, or had a stroke
  • •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

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
    • •you have symptoms of heart problems or stroke:
      • •chest pain
      • •trouble breathing
      • •weakness in one part or side of body
      • •slurred speech
      • •leg swelling
      • •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.


Advil Tablets



  • 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
  • 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


Advil Caplets



  • do not take more than directed
  • the smallest effective dose should be used
  • •adults and children 12 years and over: take 1 caplet every 4 to 6 hours while symptoms persist
  • •if pain or fever does not respond to 1 caplet, 2 caplets may be used
  • •do not exceed 6 caplets in 24 hours, unless directed by a doctor
  • •children under 12 years: ask a doctor
  • 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


Advil Gel Caplets



  • do not take more than directed
  • the smallest effective dose should be used
  • •adults and children 12 years and over: take 1 gel caplet every 4 to 6 hours while symptoms persist
  • •if pain or fever does not respond to 1 gel caplet, 2 gel caplets may be used
  • •do not exceed 6 gel caplets in 24 hours, unless directed by a doctor
  • •children under 12 years: ask a doctor
  • colloidal silicon dioxide, corn starch, croscarmellose sodium, FD&C red no. 40, FD&C yellow no. 6, fractionated coconut oil, gelatin, glycerin, hypromellose, pharmaceutical ink, pregelatinized starch, propyl gallate, purified water, sodium lauryl sulfate, stearic acid, synthetic iron oxides, titanium dioxide, triacetin


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)

Questions Or Comments?



call toll free 1-800-88-ADVIL


Principal Display Panel - 200 Mg Gel Caplet Bottle Label



Advil®

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

100 Gel Caplets
Gel Caplets

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.


Principal Display Panel - 100 Count 200 Mg Gel Caplet Bottle Carton



Advil®

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

100 Coated Gel Caplets*
*Capsule-Shaped Gelatin-Coated Tablets

Gel
Caplets


Principal Display Panel - 2 Count 200 Mg Tablet Pouch



Advil®

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

2 Coated Tablets


Principal Display Panel - 50 Pouch Dispenser



Advil®

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

Tablets

  • 1.Headache
  • 2.Minor Pain of Arthritis
  • 3.Toothache
  • 4.Muscular Aches
  • 5.Menstrual Cramps
  • 6.Fever
  • 50 PACKETS OF 2 COATED TABLETS EACH


Principal Display Panel - 300 Tablet Bottle Label - Ndc 0573-0154-98



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

300 Coated Tablets

Tablets


Principal Display Panel - 200 Count 200 Mg Tablet Bottle Label



New Easy Open
ARTHRITIS CAP

Arthritis Foundation
Ease of
UseSM
CAP

THIS PACKAGE FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN

Advil®

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

200 Coated Tablets

Tablets


Principal Display Panel - 10 Tablet Vial Label



Advil®

Tablets

Ibuprofen Tablets, 200 mg
Pain Reliever/Fever Reducer (NSAID)
10 Coated Tablets


Principal Display Panel - 200 Mg Tablet Vial Label



Advil ®

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

10 Tablets

Tablets


Principal Display Panel - 10 Tablet Package



Pocket
Pack

Do not use if blister is open or the
words "ADVIL SAFETY SEALED"
under blister are missing or torn.

Advil®

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

10 Coated Tablets

Tablets


Principal Display Panel - 115 Tablet Bottle Label



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

115 Tablets

Tablets

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.


Principal Display Panel - 115 Tablet Bottle Carton - Ndc 0573-0151-05



15
FREE
TABLETS

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

115
Coated Tablets

Tablets


Principal Display Panel - 225 Caplet Bottle Label



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

225 Caplets

Caplets

READ AND KEEP CARTON FOR COMPLETE
WARNINGS AND INFORMATION


Principal Display Panel - 225 Caplet Bottle Carton - Ndc 0573-0161-85



25
FREE
CAPLETS

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

225
Coated Caplets*
*Capsule-Shaped Tablets

Caplets


Principal Display Panel - 24 Tablet Bottle Label



Advil®

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

24 Tablets

Tablets

READ AND KEEP CARTON FOR COMPLETE
WARNINGS AND INFORMATION


Principal Display Panel - 24 Tablet Bottle Carton - Ndc 0573-0150-20



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

24 Coated Tablets

Tablets


Principal Display Panel - 100 Tablet Bottle Label



Advil®

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

100 Tablets
Tablets

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.

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

100 Tablets

Tablets

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.


Principal Display Panel - 100 Count 200 Mg Tablet Bottle Carton



Advil®

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

100 Coated Tablets

Tablets


Principal Display Panel - 100 Coated Tablet Bottle Carton - Ndc 0573-0150-40



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

100 Coated Tablets

Tablets


Principal Display Panel - 24 Caplet Bottle Label



Advil®

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

24 Caplets

Caplets

READ AND KEEP CARTON FOR COMPLETE
WARNINGS AND INFORMATION


Principal Display Panel - 24 Caplet Bottle Carton - Ndc 0573-0160-20



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

24 Coated Caplets*
*Capsule-Shaped Tablets

Caplets


Principal Display Panel - 200 Mg Caplet Bottle Label



Advil®

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

100 Caplets
Caplets

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.


Principal Display Panel - 100 Count 200 Mg Caplet Bottle Carton



Advil®

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

50 Coated Caplets*
*Capsule-Shaped Tablets

Caplets


Principal Display Panel - 36 Caplet Bottle Label



Advil®

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

36 Caplets

Caplets

READ AND KEEP CARTON FOR COMPLETE
WARNINGS AND INFORMATION


Principal Display Panel - 36 Caplet Bottle Carton - Ndc 0573-0160-25



50%
MORE
FREE

12 Free
Caplets

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

36
Coated Caplets*
*Capsule-Shaped Tablets

Caplets


* Please review the disclaimer below.