ADVIL ALLERGY SINUS description, usages, side effects, indications, overdosage, supplying and lots more!

ADVIL ALLERGY SINUS

Pfizer Consumer Healthcare

  • Description
  • Clinical Pharmacology
  • Indications & Usage
  • Contraindications
  • Warnings
  • Precautions
  • Side Effects
  • Overdosage
  • Dosage & Administration
  • How Supplied
  • Patient Counseling Information
  • Supplemental Patient Material
  • Boxed Warning
  • Patient Package Insert
Advil Allergy Sinus (chlorpheniramine maleate, ibuprofen, and psuedoephedrine HCl)

FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

DRUG FACTS

ACTIVE INGREDIENTS (IN EACH CAPLET)

Chlorpheniramine maleate 2 mg

Ibuprofen 200 mg (NSAID)*

Pseudoephedrine HCl 30 mg

*nonsteroidal anti-inflammatory drug

PURPOSES

Antihistamine

Pain reliever/fever reducer

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 aches and pains
  • 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 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

Do not use

  • in children under 12 years of 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, or trouble urinating due to an enlarged prostate gland
  • 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 pseudoephedrine, 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
  • the risk of heart attack or stroke may increase if you use more than directed or for longer than directed
  • avoid alcoholic drinks
  • be careful when driving a motor vehicle or operating machinery
  • drowsiness may occur
  • alcohol, sedatives, and tranquilizers may increase drowsiness

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
  • 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

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

  • do not take more than directed
  • the smallest effective dose should be used
  • adults: take 1 caplet every 4-6 hours while symptoms persist.
  • do not take more than 6 caplets in any 24-hour period, unless directed by a doctor
  • children under 12 years of age: do not use

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

carnauba wax, colloidal silicon dioxide, corn starch, croscarmellose sodium, FD&C red no. 40 aluminum lake, FD&C yellow no. 6 aluminum lake, glyceryl behenate, hypromellose, microcrystalline cellulose, pharmaceutical ink, polydextrose, polyethylene glycol, pregelatinized starch, propylene glycol, silicon dioxide, titanium dioxide

QUESTIONS OR COMMENTS?

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

Pfizer, Madison, NJ 07940 USA ©2011 Pfizer Inc.

For most recent product information, visit www.advil.com

U.S. Patent number 7,863,287

PRINCIPAL DISPLAY PANEL - 10 Tablet Blister Pack

Advil ®
ALLERGY SINUS
Ibuprofen 200 mg /
Pseudoephedrine HCl 30 mg /
Chlorpheniramine Maleate 2 mg
See warnings before use.
Pfizer, Madison, NJ 07940 USA

AREA FOR EXP. & LOT

PEEL & PUSH

PRINCIPAL DISPLAY PANEL - 10 Tablet Blister Pack

PRINCIPAL DISPLAY PANEL - 20 Tablet Blister Pack Carton

Advil ®

ALLERGY SINUS

Ibuprofen 200 mg ➤ Pain Reliever/Fever Reducer (NSAID)
Pseudoephedrine HCl 30 mg ➤ Nasal Decongestant
Chlorpheniramine Maleate 2 mg ➤ Antihistamine

Relieves Runny Nose, Nasal Congestion, Sneezing,
Itchy, Watery Eyes, Headache and Sinus Pressure

ONLY
1
PILL
EVERY
4-6
HOURS

20
COATED
CAPLETS*

*Capsule-Shaped Tablets

PRINCIPAL DISPLAY PANEL - 20 Tablet Blister Pack Carton

ADVIL ALLERGY SINUS

chlorpheniramine maleate, ibuprofen, pseudoephedrine HCl TABLET, COATED

Product Information

Product Type Human otc drug label Item Code (Source) NDC:0573-0188
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
Chlorpheniramine Maleate CHLORPHENIRAMINE 2 mg
IBUPROFEN IBUPROFEN 200 mg
Pseudoephedrine Hydrochloride Pseudoephedrine 30 mg

Inactive Ingredients

Ingredient Name Strength
carnauba wax
SILICON DIOXIDE
STARCH, CORN
CROSCARMELLOSE SODIUM
FD&C RED NO. 40
FD&C YELLOW NO. 6
GLYCERYL DIBEHENATE
cellulose, microcrystalline
POLYDEXTROSE
HYPROMELLOSES
POLYETHYLENE GLYCOLS
titanium dioxide

Product Characteristics

Color Size Imprint Code Shape
ORANGE (bright orange) 15 mm Advil;A;S OVAL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 1 in 1 BLISTER PACK
2 NDC:0573-0188-10 20 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021441 2002-12-20


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