FDA Label for Advil
View Indications, Usage & Precautions
- ADVIL TABLETS (IN EACH TABLET)
- ADVIL CAPLETS (IN EACH CAPLET)
- ADVIL GEL CAPLETS (IN EACH GEL CAPLET)
- PURPOSE
- USES
- ALLERGY ALERT:
- STOMACH BLEEDING WARNING:
- HEART ATTACK AND STROKE WARNING
- DO NOT USE
- ASK A DOCTOR BEFORE USE IF
- ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
- WHEN USING THIS PRODUCT
- STOP USE AND ASK A DOCTOR IF
- IF PREGNANT OR BREAST-FEEDING,
- KEEP OUT OF REACH OF CHILDREN.
- ADVIL TABLETS
- ADVIL CAPLETS
- ADVIL GEL CAPLETS
- OTHER INFORMATION
- QUESTIONS OR COMMENTS?
- PRINCIPAL DISPLAY PANEL - 200 MG GEL CAPLET BOTTLE LABEL
- PRINCIPAL DISPLAY PANEL - 100 COUNT 200 MG GEL CAPLET BOTTLE CARTON
- PRINCIPAL DISPLAY PANEL - 2 COUNT 200 MG TABLET POUCH
- PRINCIPAL DISPLAY PANEL - 50 POUCH DISPENSER
- PRINCIPAL DISPLAY PANEL - 300 TABLET BOTTLE LABEL - NDC 0573-0154-98
- PRINCIPAL DISPLAY PANEL - 200 COUNT 200 MG TABLET BOTTLE LABEL
- PRINCIPAL DISPLAY PANEL - 10 TABLET VIAL LABEL
- PRINCIPAL DISPLAY PANEL - 200 MG TABLET VIAL LABEL
- PRINCIPAL DISPLAY PANEL - 10 TABLET PACKAGE
- PRINCIPAL DISPLAY PANEL - 115 TABLET BOTTLE LABEL
- PRINCIPAL DISPLAY PANEL - 115 TABLET BOTTLE CARTON - NDC 0573-0151-05
- PRINCIPAL DISPLAY PANEL - 225 CAPLET BOTTLE LABEL
- PRINCIPAL DISPLAY PANEL - 225 CAPLET BOTTLE CARTON - NDC 0573-0161-85
- PRINCIPAL DISPLAY PANEL - 24 TABLET BOTTLE LABEL
- PRINCIPAL DISPLAY PANEL - 24 TABLET BOTTLE CARTON - NDC 0573-0150-20
- PRINCIPAL DISPLAY PANEL - 100 TABLET BOTTLE LABEL
- PRINCIPAL DISPLAY PANEL - 100 COUNT 200 MG TABLET BOTTLE CARTON
- PRINCIPAL DISPLAY PANEL - 100 COATED TABLET BOTTLE CARTON - NDC 0573-0150-40
- PRINCIPAL DISPLAY PANEL - 24 CAPLET BOTTLE LABEL
- PRINCIPAL DISPLAY PANEL - 24 CAPLET BOTTLE CARTON - NDC 0573-0160-20
- PRINCIPAL DISPLAY PANEL - 200 MG CAPLET BOTTLE LABEL
- PRINCIPAL DISPLAY PANEL - 100 COUNT 200 MG CAPLET BOTTLE CARTON
- PRINCIPAL DISPLAY PANEL - 36 CAPLET BOTTLE LABEL
- PRINCIPAL DISPLAY PANEL - 36 CAPLET BOTTLE CARTON - NDC 0573-0160-25
Advil Product Label
The following document was submitted to the FDA by the labeler of this product Haleon Us Holdings Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
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. Headache2. Minor Pain of Arthritis3. Toothache4. Muscular Aches5. Menstrual Cramps6. 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.