ADVIL- ibuprofen tablet coated tablet, coated

ADVIL by

Drug Labeling and Warnings

ADVIL by is a Otc medication manufactured, distributed, or labeled by Mechanical Servants LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Drug Facts

Active ingredient (in each tablet)

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

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 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 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

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

SPL UNCLASSIFIED SECTION

Repackaged and distributed with permission of GSK Consumer Healthcare by:
Convenience Valet®, Glendale Heights, IL 60139

PRINCIPAL DISPLAY PANEL

Advil

Ibuprofen Tablets, 200mg

Pain Reliever/Fever Reducer (NSAID)

2 Packets of

2 Coated Tablets Each

Advil

Tablets

PRINCIPAL DISPLAY PANEL

Advil

Ibuprofen Tablets, 200mg

Pain Reliever/Fever Reducer (NSAID)

3 Packets of

2 Coated Tablets Each

Advil

Tablets

PRINCIPAL DISPLAY PANEL

Advil

Ibuprofen Tablets, 200mg

Pain Reliever/Fever Reducer (NSAID)

• Headache
• Minor Pain of Arthritis
• Toothache
• Muscular Aches
• Menstrual Cramps
• Fever

30 PACKETS OF 2 COATED TABLETS EACH

CVP 4 Count Carton

Advil

Ibuprofen Tablets, 200mg

Pain Reliever/Fever Reducer (NSAID)

[pill image]

Tablets

4

Coated

Tablets

CVP

HEALTH

INGREDIENTS AND APPEARANCE

ADVIL 
ibuprofen tablet coated tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 29485-1005
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM)	IBUPROFEN	200 mg

Inactive Ingredients
Ingredient Name	Strength
FERRIC OXIDE RED (UNII: 1K09F3G675)
SODIUM BENZOATE (UNII: OJ245FE5EU)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
METHYLPARABEN (UNII: A2I8C7HI9T)
SHELLAC (UNII: 46N107B71O)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STARCH, CORN (UNII: O8232NY3SJ)
SUCROSE (UNII: C151H8M554)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
WHITE WAX (UNII: 7G1J5DA97F)
DIACETYLATED MONOGLYCERIDES (UNII: 5Z17386USF)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	brown	Score	no score
Shape	OVAL	Size	15mm
Flavor		Imprint Code	ADVIL
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 29485-1005-4	2 in 1 BLISTER PACK	04/30/2002	11/18/2025
1		2 in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA018989	04/30/2002	11/18/2025

ADVIL 
ibuprofen tablet coated tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 29485-6749
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM)	IBUPROFEN	200 mg

Inactive Ingredients
Ingredient Name	Strength
FERRIC OXIDE RED (UNII: 1K09F3G675)
SODIUM BENZOATE (UNII: OJ245FE5EU)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
METHYLPARABEN (UNII: A2I8C7HI9T)
SHELLAC (UNII: 46N107B71O)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STARCH, CORN (UNII: O8232NY3SJ)
SUCROSE (UNII: C151H8M554)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
WHITE WAX (UNII: 7G1J5DA97F)
DIACETYLATED MONOGLYCERIDES (UNII: 5Z17386USF)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	brown	Score	no score
Shape	OVAL	Size	15mm
Flavor		Imprint Code	ADVIL
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 29485-6749-6	3 in 1 BLISTER PACK	02/06/2017	11/07/2025
1		2 in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA018989	02/06/2017	11/07/2025

ADVIL 
ibuprofen tablet coated tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 29485-7012
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM)	IBUPROFEN	200 mg

Inactive Ingredients
Ingredient Name	Strength
FERRIC OXIDE RED (UNII: 1K09F3G675)
SODIUM BENZOATE (UNII: OJ245FE5EU)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
METHYLPARABEN (UNII: A2I8C7HI9T)
SHELLAC (UNII: 46N107B71O)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STARCH, CORN (UNII: O8232NY3SJ)
SUCROSE (UNII: C151H8M554)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
WHITE WAX (UNII: 7G1J5DA97F)
DIACETYLATED MONOGLYCERIDES (UNII: 5Z17386USF)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	brown	Score	no score
Shape	OVAL	Size	15mm
Flavor		Imprint Code	ADVIL
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 29485-7012-3	30 in 1 BOX	11/01/2016	12/31/2025
1		2 in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA018989	11/01/2016	12/31/2025

ADVIL 
ibuprofen tablet coated tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 29485-6500
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM)	IBUPROFEN	200 mg

Inactive Ingredients
Ingredient Name	Strength
FERRIC OXIDE RED (UNII: 1K09F3G675)
SODIUM BENZOATE (UNII: OJ245FE5EU)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
METHYLPARABEN (UNII: A2I8C7HI9T)
SHELLAC (UNII: 46N107B71O)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STARCH, CORN (UNII: O8232NY3SJ)
SUCROSE (UNII: C151H8M554)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
WHITE WAX (UNII: 7G1J5DA97F)
DIACETYLATED MONOGLYCERIDES (UNII: 5Z17386USF)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	brown	Score	no score
Shape	OVAL	Size	15mm
Flavor		Imprint Code	ADVIL
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 29485-6500-4	2 in 1 BLISTER PACK	08/17/2017	12/31/2025
1		2 in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA018989	08/17/2017	12/31/2025

Labeler - Lil' Drug Store Products, Inc. (093103646)