Label: ADVIL- ibuprofen tablet, coated
-
NDC Code(s):
0573-0150-20,
0573-0150-30,
0573-0150-31,
0573-0150-32, view more0573-0150-40, 0573-0150-41, 0573-0150-42, 0573-0151-05, 0573-0151-10, 0573-0151-12, 0573-0151-13, 0573-0151-20, 0573-0151-21, 0573-0151-30, 0573-0151-48, 0573-0154-16, 0573-0154-17, 0573-0154-21, 0573-0154-35, 0573-0154-59, 0573-0154-60, 0573-0154-75, 0573-0154-84, 0573-0154-89, 0573-0154-98, 0573-0160-17, 0573-0160-20, 0573-0160-25, 0573-0160-30, 0573-0160-31, 0573-0160-40, 0573-0160-41, 0573-0160-42, 0573-0161-35, 0573-0161-51, 0573-0161-65, 0573-0161-85, 0573-0165-20, 0573-0165-25, 0573-0165-30, 0573-0165-31, 0573-0165-40, 0573-0165-41, 0573-0165-42, 0573-0166-51, 0573-0166-85, 0573-1711-14
- Packager: Haleon US Holdings LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Drug Label Information
Updated April 8, 2024
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient
- Purpose
- Uses
-
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
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
-
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
-
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
- PRINCIPAL DISPLAY PANEL – 100 Gel Caplet Bottle Carton
- PRINCIPAL DISPLAY PANEL - 300 Tablet Bottle Label
- PRINCIPAL DISPLAY PANEL - 115 Tablet Bottle Carton
- PRINCIPAL DISPLAY PANEL - 225 Caplet Bottle Carton
- PRINCIPAL DISPLAY PANEL - 24 Tablet Bottle Carton
- PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Label
- PRINCIPAL DISPLAY PANEL - 24 Caplet Bottle Carton
- Principal Display Panel - 225 Caplet Bottle Label
-
INGREDIENTS AND APPEARANCE
ADVILÂ
ibuprofen tablet, coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0573-0165 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 CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  FD&C RED NO. 40 (UNII: WZB9127XOA)  FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  FERRIC OXIDE RED (UNII: 1K09F3G675)  GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  GLYCERIN (UNII: PDC6A3C0OX)  HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  PROPYL GALLATE (UNII: 8D4SNN7V92)  SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  SODIUM LAURYL SULFATE (UNII: 368GB5141J)  STARCH, CORN (UNII: O8232NY3SJ)  STEARIC ACID (UNII: 4ELV7Z65AP)  TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  TRIACETIN (UNII: XHX3C3X673)  WATER (UNII: 059QF0KO0R)  Product Characteristics Color brown (one side is brown while the other side is yellow) Score no score Shape OVAL Size 16mm Flavor Imprint Code Advil Contains     Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0573-0165-20 1 in 1 CARTON 05/18/1984 1 24 in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:0573-0165-30 1 in 1 CARTON 05/18/1984 2 50 in 1 BOTTLE; Type 0: Not a Combination Product 3 NDC:0573-0165-40 1 in 1 CARTON 05/18/1984 3 100 in 1 BOTTLE; Type 0: Not a Combination Product 4 NDC:0573-0165-41 1 in 1 CARTON 05/18/1984 4 125 in 1 BOTTLE; Type 0: Not a Combination Product 5 NDC:0573-0165-42 1 in 1 CARTON 05/18/1984 5 150 in 1 BOTTLE; Type 0: Not a Combination Product 6 NDC:0573-0165-31 1 in 1 CARTON 05/18/1984 6 75 in 1 BOTTLE; Type 0: Not a Combination Product 7 NDC:0573-0165-25 1 in 1 CARTON 05/18/1984 7 36 in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA018989 05/18/1984 ADVILÂ
ibuprofen tablet, coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0573-0154 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 MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  FERRIC OXIDE RED (UNII: 1K09F3G675)  METHYLPARABEN (UNII: A2I8C7HI9T)  POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  PROPYLPARABEN (UNII: Z8IX2SC1OH)  SHELLAC (UNII: 46N107B71O)  SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  SODIUM BENZOATE (UNII: OJ245FE5EU)  SODIUM LAURYL SULFATE (UNII: 368GB5141J)  STARCH, CORN (UNII: O8232NY3SJ)  STEARIC ACID (UNII: 4ELV7Z65AP)  SUCROSE (UNII: C151H8M554)  TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  WHITE WAX (UNII: 7G1J5DA97F)  DIACETYLATED MONOGLYCERIDES (UNII: 5Z17386USF)  Product Characteristics Color brown (pinkish brown) Score no score Shape ROUND Size 11mm Flavor Imprint Code Advil Contains     Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0573-0154-35 1 in 1 CARTON 05/18/1984 1 150 in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:0573-0154-75 1 in 1 CARTON 05/18/1984 2 200 in 1 BOTTLE; Type 0: Not a Combination Product 3 NDC:0573-0154-17 3000 in 1 CASE 05/18/1984 3 2 in 1 POUCH; Type 0: Not a Combination Product 4 NDC:0573-0154-89 50 in 1 CASE 05/18/1984 4 2 in 1 POUCH; Type 0: Not a Combination Product 5 NDC:0573-0154-84 1 in 1 CARTON 05/18/1984 5 225 in 1 BOTTLE; Type 0: Not a Combination Product 6 NDC:0573-0154-98 300 in 1 BOTTLE; Type 0: Not a Combination Product 05/18/1984 7 NDC:0573-0154-16 3 in 1 CARTON 05/18/1984 7 2 in 1 POUCH; Type 0: Not a Combination Product 8 NDC:0573-0154-60 360 in 1 BOTTLE; Type 0: Not a Combination Product 05/18/1984 9 NDC:0573-0154-59 1 in 1 CARTON 05/18/1984 9 200 in 1 BOTTLE; Type 0: Not a Combination Product 10 NDC:0573-0154-21 200 in 1 BOTTLE; Type 0: Not a Combination Product 01/04/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA018989 05/18/1984 ADVILÂ
ibuprofen tablet, coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0573-0151 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 MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  FERRIC OXIDE RED (UNII: 1K09F3G675)  METHYLPARABEN (UNII: A2I8C7HI9T)  POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  PROPYLPARABEN (UNII: Z8IX2SC1OH)  SHELLAC (UNII: 46N107B71O)  SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  SODIUM BENZOATE (UNII: OJ245FE5EU)  SODIUM LAURYL SULFATE (UNII: 368GB5141J)  STARCH, CORN (UNII: O8232NY3SJ)  STEARIC ACID (UNII: 4ELV7Z65AP)  SUCROSE (UNII: C151H8M554)  TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  WHITE WAX (UNII: 7G1J5DA97F)  DIACETYLATED MONOGLYCERIDES (UNII: 5Z17386USF)  Product Characteristics Color brown (pinkish brown) Score no score Shape ROUND Size 11mm Flavor Imprint Code Advil Contains     Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0573-0151-12 10 in 1 VIAL; Type 0: Not a Combination Product 05/18/1984 2 NDC:0573-0151-13 3 in 1 PACKAGE 05/18/1984 2 10 in 1 VIAL; Type 0: Not a Combination Product 3 NDC:0573-0151-10 10 in 1 PACKAGE 05/18/1984 3 10 in 1 VIAL; Type 0: Not a Combination Product 4 NDC:0573-0151-21 1 in 1 CARTON 05/18/1984 4 36 in 1 BOTTLE; Type 0: Not a Combination Product 5 NDC:0573-0151-20 2 in 1 PACKAGE 05/18/1984 5 10 in 1 VIAL; Type 0: Not a Combination Product 6 NDC:0573-0151-48 2 in 1 PACKAGE 05/18/1984 6 1 in 1 CARTON 6 100 in 1 BOTTLE; Type 0: Not a Combination Product 7 NDC:0573-0151-30 1 in 1 CARTON 05/18/1984 7 130 in 1 BOTTLE; Type 0: Not a Combination Product 8 NDC:0573-0151-05 1 in 1 CARTON 05/18/1984 8 115 in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA018989 05/18/1984 ADVILÂ
ibuprofen tablet, coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0573-0161 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 MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  FERRIC OXIDE RED (UNII: 1K09F3G675)  METHYLPARABEN (UNII: A2I8C7HI9T)  POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  PROPYLPARABEN (UNII: Z8IX2SC1OH)  SHELLAC (UNII: 46N107B71O)  SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  SODIUM BENZOATE (UNII: OJ245FE5EU)  SODIUM LAURYL SULFATE (UNII: 368GB5141J)  STARCH, CORN (UNII: O8232NY3SJ)  STEARIC ACID (UNII: 4ELV7Z65AP)  SUCROSE (UNII: C151H8M554)  TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  WHITE WAX (UNII: 7G1J5DA97F)  DIACETYLATED MONOGLYCERIDES (UNII: 5Z17386USF)  Product Characteristics Color brown (pinkish 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:0573-0161-35 1 in 1 CARTON 05/18/1984 1 150 in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:0573-0161-51 1 in 1 CARTON 05/18/1984 2 200 in 1 BOTTLE; Type 0: Not a Combination Product 3 NDC:0573-0161-85 1 in 1 CARTON 05/18/1984 3 225 in 1 BOTTLE; Type 0: Not a Combination Product 4 NDC:0573-0161-65 65 in 1 BOTTLE; Type 0: Not a Combination Product 05/01/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA018989 05/18/1984 ADVILÂ
ibuprofen tablet, coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0573-0166 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 CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  FD&C RED NO. 40 (UNII: WZB9127XOA)  FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  FERRIC OXIDE RED (UNII: 1K09F3G675)  GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  GLYCERIN (UNII: PDC6A3C0OX)  HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  PROPYL GALLATE (UNII: 8D4SNN7V92)  SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  SODIUM LAURYL SULFATE (UNII: 368GB5141J)  STARCH, CORN (UNII: O8232NY3SJ)  STEARIC ACID (UNII: 4ELV7Z65AP)  TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  TRIACETIN (UNII: XHX3C3X673)  WATER (UNII: 059QF0KO0R)  Product Characteristics Color brown (one side is brown while the other side is yellow) Score no score Shape OVAL Size 16mm Flavor Imprint Code Advil Contains     Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0573-0166-51 1 in 1 CARTON 05/18/1984 1 200 in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:0573-0166-85 225 in 1 BOTTLE; Type 0: Not a Combination Product 05/18/1984 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA018989 05/18/1984 ADVILÂ
ibuprofen tablet, coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0573-0150 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 MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  FERRIC OXIDE RED (UNII: 1K09F3G675)  METHYLPARABEN (UNII: A2I8C7HI9T)  POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  PROPYLPARABEN (UNII: Z8IX2SC1OH)  SHELLAC (UNII: 46N107B71O)  SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  SODIUM BENZOATE (UNII: OJ245FE5EU)  SODIUM LAURYL SULFATE (UNII: 368GB5141J)  STARCH, CORN (UNII: O8232NY3SJ)  STEARIC ACID (UNII: 4ELV7Z65AP)  SUCROSE (UNII: C151H8M554)  TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  WHITE WAX (UNII: 7G1J5DA97F)  DIACETYLATED MONOGLYCERIDES (UNII: 5Z17386USF)  Product Characteristics Color brown (pinkish brown) Score no score Shape ROUND Size 11mm Flavor Imprint Code Advil Contains     Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0573-0150-20 1 in 1 CARTON 05/18/1984 1 24 in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:0573-0150-30 1 in 1 CARTON 05/18/1984 2 50 in 1 BOTTLE; Type 0: Not a Combination Product 3 NDC:0573-0150-40 1 in 1 CARTON 05/18/1984 3 100 in 1 BOTTLE; Type 0: Not a Combination Product 4 NDC:0573-0150-31 1 in 1 CARTON 05/18/1984 4 75 in 1 BOTTLE; Type 0: Not a Combination Product 5 NDC:0573-0150-32 1 in 1 CARTON 05/18/1984 5 60 in 1 BOTTLE; Type 0: Not a Combination Product 6 NDC:0573-0150-41 1 in 1 CARTON 05/18/1984 6 125 in 1 BOTTLE; Type 0: Not a Combination Product 7 NDC:0573-0150-42 1 in 1 CARTON 05/18/1984 7 150 in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA018989 05/18/1984 ADVILÂ
ibuprofen tablet, coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0573-0160 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 MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  FERRIC OXIDE RED (UNII: 1K09F3G675)  METHYLPARABEN (UNII: A2I8C7HI9T)  POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  PROPYLPARABEN (UNII: Z8IX2SC1OH)  SHELLAC (UNII: 46N107B71O)  SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  SODIUM BENZOATE (UNII: OJ245FE5EU)  SODIUM LAURYL SULFATE (UNII: 368GB5141J)  STARCH, CORN (UNII: O8232NY3SJ)  STEARIC ACID (UNII: 4ELV7Z65AP)  SUCROSE (UNII: C151H8M554)  TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  WHITE WAX (UNII: 7G1J5DA97F)  DIACETYLATED MONOGLYCERIDES (UNII: 5Z17386USF)  Product Characteristics Color brown (pinkish 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:0573-0160-20 1 in 1 CARTON 05/18/1984 1 24 in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:0573-0160-30 1 in 1 CARTON 05/18/1984 2 50 in 1 BOTTLE; Type 0: Not a Combination Product 3 NDC:0573-0160-40 1 in 1 CARTON 05/18/1984 3 100 in 1 BOTTLE; Type 0: Not a Combination Product 4 NDC:0573-0160-25 1 in 1 CARTON 05/18/1984 4 36 in 1 BOTTLE; Type 0: Not a Combination Product 5 NDC:0573-0160-31 1 in 1 CARTON 05/18/1984 5 75 in 1 BOTTLE; Type 0: Not a Combination Product 6 NDC:0573-0160-41 1 in 1 CARTON 05/18/1984 6 125 in 1 BOTTLE; Type 0: Not a Combination Product 7 NDC:0573-0160-42 1 in 1 CARTON 05/18/1984 7 150 in 1 BOTTLE; Type 0: Not a Combination Product 8 NDC:0573-0160-17 1 in 1 CARTON 05/18/1984 8 115 in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA018989 05/18/1984 ADVILÂ
ibuprofen tablet, coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0573-1711 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 MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  FERRIC OXIDE RED (UNII: 1K09F3G675)  METHYLPARABEN (UNII: A2I8C7HI9T)  POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  PROPYLPARABEN (UNII: Z8IX2SC1OH)  SHELLAC (UNII: 46N107B71O)  SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  SODIUM BENZOATE (UNII: OJ245FE5EU)  SODIUM LAURYL SULFATE (UNII: 368GB5141J)  STARCH, CORN (UNII: O8232NY3SJ)  STEARIC ACID (UNII: 4ELV7Z65AP)  SUCROSE (UNII: C151H8M554)  TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  WHITE WAX (UNII: 7G1J5DA97F)  DIACETYLATED MONOGLYCERIDES (UNII: 5Z17386USF)  Product Characteristics Color brown (pinkish brown) Score no score Shape ROUND Size 11mm Flavor Imprint Code Advil Contains     Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0573-1711-14 1 in 1 CARTON 05/18/1984 1 225 in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA018989 05/18/1984 Labeler - Haleon US Holdings LLC (079944263)