FDA Label for Advil Allergy And Congestion Relief

View Indications, Usage & Precautions

Advil Allergy And Congestion Relief 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 - Purpose

Active ingredients (in each tablet)	Purposes
Chlorpheniramine maleate 4 mg	Antihistamine
Ibuprofen 200 mg (NSAID) nonsteroidal anti-inflammatory drug	Pain reliever/Fever reducer
Phenylephrine HCl 10 mg	Nasal decongestant

Uses

temporarily relieves these symptoms associated with hay fever or other upper respiratory allergies, and the common cold:
- runny nose
- itchy, watery eyes
- itching of the nose or throat
- sneezing
- nasal congestion
- sinus pressure
- headache
- minor body aches and pains
- fever
- reduces swelling of the nasal passages
- temporarily restores freer breathing through the nose

Allergy Alert

Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:

hives
asthma (wheezing)
skin reddening
blisters

facial swelling
shock
rash

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

in children under 12 years of age because this product contains too much medication for children under this age
if you have ever had an allergic reaction to any other pain reliever/fever reducer
right before or after heart surgery
if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask A Doctor Before Use If

you have a breathing problem such as emphysema or chronic bronchitis
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, thyroid disease, diabetes, glaucoma, have trouble urinating due to an enlarged prostate gland, 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 sedatives or tranquilizers
taking any other product that contains phenylephrine, chlorpheniramine or any other nasal decongestant or antihistamine
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
avoid alcoholic drinks
be careful when driving a motor vehicle or operating machinery
drowsiness may occur
alcohol, sedatives, and tranquilizers may increase drowsiness
may cause excitability especially in children

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 7 days
  - fever gets worse or lasts more than 3 days
  - nasal congestion lasts for more than 7 days
  - redness or swelling is present in the painful area
  - you get nervous, dizzy, or sleepless
  - symptoms continue or get worse
  - 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.

Directions

do not take more than directed
adults and children 12 years of age and over:
- take 1 tablet every 4 hours while symptoms persist
- do not take more than 6 tablets in any 24-hour period, unless directed by a doctor
- children under 12 years of age: do not use because this product contains too much medication for children under this age

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

acesulfame potassium, artificial flavors, carnauba wax, colloidal silicon dioxide, corn starch, croscarmellose sodium, glycerin, glyceryl behenate, hypromellose, lactic acid, lecithin, maltodextrin, medium-chain triglycerides, microcrystalline cellulose, pharmaceutical ink, polydextrose, polyvinyl alcohol, pregelatinized starch, propyl gallate, silicon dioxide, sucralose, synthetic iron oxide, talc, titanium dioxide, triacetin, xanthan gum

Questions Or Comments?

Call weekdays from 9 AM to 5 PM EST toll free at 1-800-88-ADVIL

Principal Display Panel - 1 Tablet Packet

Advil^®
ALLERGY & CONGESTION RELIEF

Chlorpheniramine Maleate 4 mg
Antihistamine
Ibuprofen 200 mg (NSAID)*
Pain reliever/Fever reducer
Phenylephrine HCl 10 mg
Nasal decongestant

1 Tablet
*nonsteroidal anti-inflammatory drug

Principal Display Panel - 50 Packet Tray

Advil^®

ALLERGY & CONGESTION RELIEF

Chlorpheniramine Maleate 4 mg Antihistamine
Ibuprofen 200 mg Pain Reliever/Fever Reducer (NSAID)
Phenylephrine HCl 10 mg Nasal Decongestant

1
PILL
DOSAGE

Advil
A&CR

Relief of: Sinus Pressure, Nasal Swelling &
Congestion, Sneezing, Runny Nose and Headache

50 PACKETS OF 1 COATED TABLET

Principal Display Panel - 10 Tablet Blister Pack Carton