ADVIL- ibuprofen tablet, coated

United States - English - NLM (National Library of Medicine)

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Active ingredient:
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM)
Available from:
Wyeth Pharmaceuticals Company
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Pain reliever/Fever reducer - temporarily relieves minor aches and pains due to: headache toothache backache menstrual cramps the common cold muscular aches minor pain of arthritis - headache - toothache - backache - menstrual cramps - the common cold - muscular aches - minor pain of arthritis - temporarily reduces fever
Product summary:
Product: 52904-794 NDC: 52904-794-05 2 TABLET, COATED in a POUCH / 1 in a CARTON NDC: 52904-794-01 2 TABLET, COATED in a POUCH / 1 in a BLISTER PACK NDC: 52904-794-02 2 TABLET, COATED in a POUCH / 2 in a BLISTER PACK NDC: 52904-794-06 2 TABLET, COATED in a POUCH / 2 in a CARTON Product: 52904-786 NDC: 52904-786-50 2 TABLET, COATED in a POUCH / 50 in a CASE Product: 52904-790 NDC: 52904-790-30 2 TABLET, COATED in a POUCH / 30 in a CASE Product: 52904-791 NDC: 52904-791-25 2 TABLET, COATED in a POUCH / 25 in a CASE
Authorization status:
New Drug Application
Authorization number:
52904-786-50, 52904-790-30, 52904-791-25, 52904-794-01, 52904-794-02, 52904-794-05, 52904-794-06

ADVIL- ibuprofen tablet, coated

Wyeth Pharmaceuticals Company

----------

ADVIL Tablets

(ibuprofen)

DRUG FACTS

ACTIVE INGREDIENT

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

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

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.

DIRECTIONS

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

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

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

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

Advil Tablets

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

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

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

Questions or comments?

call toll free 1-800-88-ADVIL

HOW SUPPLIED

Product: 52904-794

NDC: 52904-794-05 2 TABLET, COATED in a POUCH / 1 in a CARTON

NDC: 52904-794-01 2 TABLET, COATED in a POUCH / 1 in a BLISTER PACK

NDC: 52904-794-02 2 TABLET, COATED in a POUCH / 2 in a BLISTER PACK

NDC: 52904-794-06 2 TABLET, COATED in a POUCH / 2 in a CARTON

Product: 52904-786

NDC: 52904-786-50 2 TABLET, COATED in a POUCH / 50 in a CASE

Product: 52904-790

NDC: 52904-790-30 2 TABLET, COATED in a POUCH / 30 in a CASE

Product: 52904-791

NDC: 52904-791-25 2 TABLET, COATED in a POUCH / 25 in a CASE

IBUPROFEN

ADVIL (IBUPROFEN) TABLET, COATED

ADVIL (IBUPROFEN) TABLET, COATED

ADVIL (IBUPROFEN)

ADVIL

ibuprofen tablet, coated

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:529 0 4-79 1

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

IBUPRO FEN (UNII: WK2XYI10 QM) (IBUPROFEN - UNII:WK2XYI10 QM)

IBUPROFEN

20 0 mg

Inactive Ingredients

Ingredient Name

Stre ng th

MICRO CRYSTALLINE CELLULO SE (UNII: OP1R32D6 1U)

CRO SCARMELLO SE SO DIUM (UNII: M28 OL1HH48 )

FERRIC O XIDE RED (UNII: 1K0 9 F3G6 75)

METHYLPARABEN (UNII: A2I8 C7HI9 T)

PO VIDO NE, UNSPECIFIED (UNII: FZ9 8 9 GH9 4E)

PRO PYLPARABEN (UNII: Z8 IX2SC1OH)

SHELLAC (UNII: 46 N10 7B71O)

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

SO DIUM BENZO ATE (UNII: OJ245FE5EU)

SO DIUM LAURYL SULFATE (UNII: 36 8 GB5141J)

STARCH, CO RN (UNII: O8 232NY3SJ)

STEARIC ACID (UNII: 4ELV7Z6 5AP)

SUCRO SE (UNII: C151H8 M554)

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

WHITE WAX (UNII: 7G1J5DA9 7F)

DIACETYLATED MO NO GLYCERIDES (UNII: 5Z1738 6 USF)

Product Characteristics

Color

BROWN (pinkish bro wn)

S core

no sco re

S hap e

ROUND

S iz e

11mm

Flavor

Imprint Code

Advil

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:529 0 4-79 1-25

25 in 1 CASE

0 1/0 1/20 17

1

2 in 1 POUCH; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

NDA0 18 9 8 9

0 5/18 /19 8 4

ADVIL

ibuprofen tablet, coated

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:529 0 4-79 0

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

IBUPRO FEN (UNII: WK2XYI10 QM) (IBUPROFEN - UNII:WK2XYI10 QM)

IBUPROFEN

20 0 mg

Inactive Ingredients

Ingredient Name

Stre ng th

MICRO CRYSTALLINE CELLULO SE (UNII: OP1R32D6 1U)

CRO SCARMELLO SE SO DIUM (UNII: M28 OL1HH48 )

FERRIC O XIDE RED (UNII: 1K0 9 F3G6 75)

METHYLPARABEN (UNII: A2I8 C7HI9 T)

PO VIDO NE, UNSPECIFIED (UNII: FZ9 8 9 GH9 4E)

PRO PYLPARABEN (UNII: Z8 IX2SC1OH)

SHELLAC (UNII: 46 N10 7B71O)

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

SO DIUM BENZO ATE (UNII: OJ245FE5EU)

SO DIUM LAURYL SULFATE (UNII: 36 8 GB5141J)

STARCH, CO RN (UNII: O8 232NY3SJ)

STEARIC ACID (UNII: 4ELV7Z6 5AP)

SUCRO SE (UNII: C151H8 M554)

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

WHITE WAX (UNII: 7G1J5DA9 7F)

DIACETYLATED MO NO GLYCERIDES (UNII: 5Z1738 6 USF)

Product Characteristics

Color

BROWN (pinkish bro wn)

S core

no sco re

S hap e

ROUND

S iz e

11mm

Flavor

Imprint Code

Advil

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:529 0 4-79 0 -30

30 in 1 CASE

0 5/29 /20 19

1

2 in 1 POUCH; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

NDA0 18 9 8 9

0 5/18 /19 8 4

ADVIL

ibuprofen tablet, coated

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:529 0 4-78 6

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

IBUPRO FEN (UNII: WK2XYI10 QM) (IBUPROFEN - UNII:WK2XYI10 QM)

IBUPROFEN

20 0 mg

Inactive Ingredients

Ingredient Name

Stre ng th

MICRO CRYSTALLINE CELLULO SE (UNII: OP1R32D6 1U)

CRO SCARMELLO SE SO DIUM (UNII: M28 OL1HH48 )

FERRIC O XIDE RED (UNII: 1K0 9 F3G6 75)

METHYLPARABEN (UNII: A2I8 C7HI9 T)

PO VIDO NE, UNSPECIFIED (UNII: FZ9 8 9 GH9 4E)

PRO PYLPARABEN (UNII: Z8 IX2SC1OH)

SHELLAC (UNII: 46 N10 7B71O)

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

SO DIUM BENZO ATE (UNII: OJ245FE5EU)

SO DIUM LAURYL SULFATE (UNII: 36 8 GB5141J)

STARCH, CO RN (UNII: O8 232NY3SJ)

STEARIC ACID (UNII: 4ELV7Z6 5AP)

SUCRO SE (UNII: C151H8 M554)

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

WHITE WAX (UNII: 7G1J5DA9 7F)

DIACETYLATED MO NO GLYCERIDES (UNII: 5Z1738 6 USF)

Product Characteristics

Color

BROWN (pinkish bro wn)

S core

no sco re

S hap e

ROUND

S iz e

11mm

Flavor

Imprint Code

Advil

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:529 0 4-78 6 -50

50 in 1 CASE

0 5/29 /20 19

1

2 in 1 POUCH; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

NDA0 18 9 8 9

0 5/18 /19 8 4

ADVIL

ibuprofen tablet, coated

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:529 0 4-79 4

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

IBUPRO FEN (UNII: WK2XYI10 QM) (IBUPROFEN - UNII:WK2XYI10 QM)

IBUPROFEN

20 0 mg

Inactive Ingredients

Ingredient Name

Stre ng th

MICRO CRYSTALLINE CELLULO SE (UNII: OP1R32D6 1U)

CRO SCARMELLO SE SO DIUM (UNII: M28 OL1HH48 )

FERRIC O XIDE RED (UNII: 1K0 9 F3G6 75)

METHYLPARABEN (UNII: A2I8 C7HI9 T)

PO VIDO NE, UNSPECIFIED (UNII: FZ9 8 9 GH9 4E)

PRO PYLPARABEN (UNII: Z8 IX2SC1OH)

SHELLAC (UNII: 46 N10 7B71O)

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

SO DIUM BENZO ATE (UNII: OJ245FE5EU)

SO DIUM LAURYL SULFATE (UNII: 36 8 GB5141J)

STARCH, CO RN (UNII: O8 232NY3SJ)

STEARIC ACID (UNII: 4ELV7Z6 5AP)

SUCRO SE (UNII: C151H8 M554)

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

WHITE WAX (UNII: 7G1J5DA9 7F)

DIACETYLATED MO NO GLYCERIDES (UNII: 5Z1738 6 USF)

Product Characteristics

Color

BROWN (pinkish bro wn)

S core

no sco re

S hap e

ROUND

S iz e

11mm

Flavor

Imprint Code

Advil

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:529 0 4-79 4-0 5

1 in 1 CARTON

0 1/0 1/20 17

1

2 in 1 POUCH; Type 0 : No t a Co mbinatio n Pro duct

Wyeth Pharmaceuticals Company

2

NDC:529 0 4-79 4-0 1

1 in 1 BLISTER PACK

0 1/0 1/20 17

2

2 in 1 POUCH; Type 0 : No t a Co mbinatio n Pro duct

3

NDC:529 0 4-79 4-0 2

2 in 1 BLISTER PACK

0 1/0 1/20 17

3

2 in 1 POUCH; Type 0 : No t a Co mbinatio n Pro duct

4

NDC:529 0 4-79 4-0 6

2 in 1 CARTON

0 1/0 1/20 17

4

2 in 1 POUCH; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

NDA0 18 9 8 9

0 5/18 /19 8 4

Labeler -

Wyeth Pharmaceuticals Company (053805599)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Select Co rpo ratio n

8 29 39 0 9 75

manufacture(529 0 4-79 4, 529 0 4-78 6 , 529 0 4-79 0 , 529 0 4-79 1)

Revised: 5/2019

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