ADVIL- ibuprofen sodium tablet, coated 
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC

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Drug Facts

Active ingredient (in each tablet)

Ibuprofen 200 mg (provided as ibuprofen sodium 256 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

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

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 at 20 weeks or later in 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

each tablet contains: sodium 22 mg
read all warnings and directions before use.
store at 20-25°C (68-77°F)
avoid excessive heat above 40°C (104°F)

Inactive ingredients

acesulfame potassium, caramel color, carnauba wax, colloidal silicon dioxide, copovidone, ferric oxide, hypromellose, mannitol, medium-chain triglycerides, microcrystalline cellulose, natural and artificial flavor, pharmaceutical ink, polyethylene glycol, propylene glycol, sodium lauryl sulfate, sucralose, titanium dioxide

Questions or comments?

Call weekdays 9 AM to 5 PM EST at 1-800-88-ADVIL

Additional Information

Do Not Use if the sealed child resistant pouch is broken or torn.

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

For US Patent or Application status see www.productpats.com

Distributed by: GSK Consumer Healthcare, Warren, NJ 07059

Trademarks are owned by or licensed to the GSK group of companies

©2021 GSK group of companies or its licensor

PRINCIPAL DISPLAY PANEL

NDC 0573-0133-02

Advil

FILM-COATED
IBUPROFEN
SODIUM

Ibuprofen Tablets, 200 mg
(Provided as Ibuprofen Sodium 256 mg)
Pain Reliever / Fever Reducer (NSAID)

Advil Tablets

Headache
Muscular Aches
Minor Pain of Arthritis
Menstrual Cramps
Toothache
Fever

See Full Drug Facts information on the back of this dispenser

50 PACKETS of

2 TABLETS EACH

000068427 Front Carton

Advil Film Coated Tablets 50x2ct

PRINCIPAL DISPLAY PANEL

Advil®

20
FREE
TABLETS

Ibuprofen Tablets, 200 mg
(Provided as Ibuprofen Sodium 256 mg)
Pain Reliever / Fever Reducer (NSAID)

FILM-COATED
IBUPROFEN
SODIUM

Advil Tablets

100
Tablets

PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Carton
ADVIL 
ibuprofen sodium tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0573-0133
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN SODIUM (UNII: RM1CE97Z4N) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN SODIUM256 mg
Inactive Ingredients
Ingredient NameStrength
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
CARAMEL (UNII: T9D99G2B1R)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
COPOVIDONE K25-31 (UNII: D9C330MD8B)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
MANNITOL (UNII: 3OWL53L36A)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorBROWN (beige) Scoreno score
ShapeROUNDSize10mm
FlavorImprint Code Advil;asymmetrical;underline
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0573-0133-201 in 1 CARTON07/08/2013
120 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:0573-0133-401 in 1 CARTON07/08/2013
240 in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:0573-0133-801 in 1 CARTON07/08/2013
380 in 1 BOTTLE; Type 0: Not a Combination Product
4NDC:0573-0133-0250 in 1 TRAY07/08/2013
42 in 1 PACKET; Type 0: Not a Combination Product
5NDC:0573-0133-042 in 1 BLISTER PACK07/08/2013
52 in 1 PACKET; Type 0: Not a Combination Product
6NDC:0573-0133-891 in 1 CARTON07/08/2013
6160 in 1 BOTTLE; Type 0: Not a Combination Product
7NDC:0573-0133-811 in 1 CARTON07/08/2013
7100 in 1 BOTTLE; Type 0: Not a Combination Product
8NDC:0573-0133-052 in 1 CARTON07/08/2013
82 in 1 PACKET; Type 0: Not a Combination Product
9NDC:0573-0133-882 in 1 PACKAGE07/08/2013
9120 in 1 BOTTLE; Type 0: Not a Combination Product
10NDC:0573-0133-411 in 1 CARTON08/12/2015
1040 in 1 BOTTLE; Type 0: Not a Combination Product
11NDC:0573-0133-911 in 1 CARTON12/01/2014
11180 in 1 BOTTLE; Type 0: Not a Combination Product
12NDC:0573-0133-013000 in 1 CASE08/11/2014
122 in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA20180307/08/2013
ADVIL 
ibuprofen sodium tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0573-0134
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN SODIUM (UNII: RM1CE97Z4N) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN SODIUM256 mg
Inactive Ingredients
Ingredient NameStrength
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
CARAMEL (UNII: T9D99G2B1R)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
COPOVIDONE K25-31 (UNII: D9C330MD8B)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
MANNITOL (UNII: 3OWL53L36A)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorBROWN (beige) Scoreno score
ShapeOVALSize15mm
FlavorImprint Code Advil;asymmetrical;underline
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0573-0134-201 in 1 CARTON07/08/2013
120 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:0573-0134-801 in 1 CARTON07/08/2013
280 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA20180307/08/2013
Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)
Establishment
NameAddressID/FEIBusiness Operations
Wyeth Pharmaceuticals Company829390975ANALYSIS(0573-0133, 0573-0134) , LABEL(0573-0133, 0573-0134) , MANUFACTURE(0573-0133, 0573-0134) , PACK(0573-0133, 0573-0134)

Revised: 9/2021
Document Id: aeda1ef6-01ea-48ce-81dd-15cef15b3c0d
Set id: 5be198b8-396e-4b44-8819-e2e3b5d2ad0e
Version: 15
Effective Time: 20210901
 
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC