FDA Label for Advil
View Indications, Usage & Precautions
- OTHER
- OTC - ACTIVE INGREDIENT
- OTC - PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- 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
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
- OTC - QUESTIONS
- PRINCIPAL DISPLAY PANEL - 20 TABLET BOTTLE LABEL
- PRINCIPAL DISPLAY PANEL - 20 TABLET BOTTLE CARTON
- PRINCIPAL DISPLAY PANEL - 80 TABLET BOTTLE LABEL
- PRINCIPAL DISPLAY PANEL - 80 TABLET BOTTLE CARTON
- PRINCIPAL DISPLAY PANEL - 2 TABLET PACKET
- PRINCIPAL DISPLAY PANEL - 50 PACKET TRAY
- PRINCIPAL DISPLAY PANEL - 4 TABLET BLISTER PACK
- PRINCIPAL DISPLAY PANEL - 2 X 120 BOTTLE CARTON
- PRINCIPAL DISPLAY PANEL - 20 CAPLET BOTTLE LABEL
- PRINCIPAL DISPLAY PANEL - 20 CAPLET BOTTLE CARTON
- PRINCIPAL DISPLAY PANEL - 80 CAPLET BOTTLE LABEL
- PRINCIPAL DISPLAY PANEL - 80 CAPLET BOTTLE CARTON
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.
Other
Drug Facts
Otc - Active Ingredient
Active ingredient (in each tablet)
Ibuprofen 200 mg (provided as ibuprofen sodium 256 mg) (NSAID)
nonsteroidal anti-inflammatory drug
Otc - Purpose
Purpose
Pain reliever/ Fever reducer
Indications & Usage
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
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
Otc - Pregnancy Or Breast Feeding
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.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Dosage & Administration
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
Storage And Handling
Other information
- each tablet contains: sodium 22 mg
- 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 Ingredient
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
Otc - Questions
Questions or comments?
Call weekdays 9 AM to 5 PM EST at 1-800-88-ADVIL
For most recent product information, visit www.Advil.com
Pfizer, Madison, NJ 07940 USA
Principal Display Panel - 20 Tablet Bottle Label
Advil®
Ibuprofen Tablets, 200 mg
(Provided as Ibuprofen Sodium 256 mg)
Pain Reliever / Fever Reducer (NSAID)
FILM-COATED
IBUPROFEN
SODIUM
20 Coated Tablets
Principal Display Panel - 20 Tablet Bottle Carton
Advil®
FILM-COATED
IBUPROFEN
SODIUM
Ibuprofen Tablets, 200 mg
(Provided as Ibuprofen Sodium 256 mg)
Pain Reliever / Fever Reducer (NSAID)
Tablets
20 Coated Tablets
Principal Display Panel - 80 Tablet Bottle Label
Advil®
Ibuprofen Tablets, 200 mg
(Provided as Ibuprofen Sodium 256 mg)
Pain Reliever / Fever Reducer (NSAID)
FILM-COATED
IBUPROFEN
SODIUM
80 Tablets
Principal Display Panel - 80 Tablet Bottle Carton
Advil®
FILM-COATED
IBUPROFEN
SODIUM
Ibuprofen Tablets, 200 mg
(Provided as Ibuprofen Sodium 256 mg)
Pain Reliever / Fever Reducer (NSAID)
Tablets
80 Tablets
Principal Display Panel - 2 Tablet Packet
Advil®
Ibuprofen Tablets 200 mg
(Provided as Ibuprofen Sodium 256 mg)
Pain Reliever/Fever Reducer (NSAID)
2 Coated Tablets
200 mg Each
Principal Display Panel - 50 Packet Tray
Advil®
FILM-COATED
IBUPROFEN
SODIUM
Ibuprofen Tablets, 200 mg
(Provided as Ibuprofen Sodium 256 mg)
Pain Reliever / Fever Reducer (NSAID)
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 COATED TABLETS EACH
Principal Display Panel - 4 Tablet Blister Pack
Do not use if blister is open or the
words "ADVIL SAFETY SEALED"
under blister are missing or torn.
Advil®
FILM-COATED
IBUPROFEN
SODIUM
Ibuprofen Tablets, 200 mg
(Provided as Ibuprofen Sodium 256 mg)
Pain Reliever / Fever Reducer (NSAID)
Go to Advil.com
for a coupon good on
your next purchase!
Tablets
4 Coated Tablets
Principal Display Panel - 2 X 120 Bottle Carton
Advil®
2
PACK
2x120
TABLETS
Ibuprofen Tablets, 200 mg
(Provided as Ibuprofen Sodium 256 mg)
Pain Reliever / Fever Reducer (NSAID)
Tablets
FILM-COATED
IBUPROFEN SODIUM
240 Coated Tablets
2 x 120 Count Bottles
Principal Display Panel - 20 Caplet Bottle Label
Advil®
Ibuprofen Tablets, 200 mg
(Provided as Ibuprofen Sodium 256 mg)
Pain Reliever / Fever Reducer (NSAID)
FILM-COATED
IBUPROFEN SODIUM
20 Caplets**
**capsule-shaped tablets
Principal Display Panel - 20 Caplet Bottle Carton
Advil®
FILM-COATED
IBUPROFEN
SODIUM
Ibuprofen Tablets, 200 mg
(Provided as Ibuprofen Sodium 256 mg)
Pain Reliever / Fever Reducer (NSAID)
Caplets**
20 Coated Caplets**
**capsule-shaped tablets
Principal Display Panel - 80 Caplet Bottle Label
Advil®
Ibuprofen Tablets, 200 mg
(Provided as Ibuprofen Sodium 256 mg)
Pain Reliever / Fever Reducer (NSAID)
FILM-COATED
IBUPROFEN
SODIUM
80 Caplets**
**capsule-shaped tablets
Principal Display Panel - 80 Caplet Bottle Carton
Advil®
FILM-COATED
IBUPROFEN
SODIUM
Ibuprofen Tablets, 200 mg
(Provided as Ibuprofen Sodium 256 mg)
Pain Reliever / Fever Reducer (NSAID)
Caplets**
80 Coated Caplets**
**capsule-shaped tablets
* Please review the disclaimer below.