Advil Allergy and Congestion Relief CHLORPHENIRAMINE MALEATE IBUPROFEN PHENYLEPHRINE HYDROCHLORIDE NAVAJO MANUFACTURING COMPANY INC. FDA Approved 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 • fever • minor body aches and pains • reduces swelling of the nasal passages • temporarily restores freer breathing through the nose
FunFoxMeds box
Route
ORAL
Applications
NDA022113

Drug Facts

Composition & Profile

Active Ingredients
Active ingredients (in each tablet) Chlorpheniramine Maleate 4 mg Ibuprofen 200 mg (NSAID)* Phenylephrine HCl 10 mg *nonsteroidal anti-inflammatory drug Purposes Antihistamine Pain reliever/Fever reducer Nasal decongestant
Inactive Ingredients
​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
Strengths
4 mg 200 mg 10 mg
Treats Conditions
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 Fever Minor Body Aches And Pains Reduces Swelling Of The Nasal Passages Temporarily Restores Freer Breathing Through The Nose
Pill Appearance
Shape: oval Color: gray Imprint: Advil;A;CR

Identifiers & Packaging

Container Type UNKNOWN
UNII
V1Q0O9OJ9Z WK2XYI10QM 04JA59TNSJ
Packaging

Package Labeling: Advil Allergy

Package Descriptions
  • Package Labeling: Advil Allergy

Overview

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 • fever • minor body aches and pains • reduces swelling of the nasal passages • temporarily restores freer breathing through the nose

Indications & Usage

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 • fever • minor body aches and pains • reduces swelling of the nasal passages • temporarily restores freer breathing through the nose

Dosage & Administration

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 use 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

Warnings & Precautions
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 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 or have 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 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 • 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 • 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 • 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 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.
Purpose

Purposes Antihistamine Pain reliever/Fever reducer Nasal decongestant

Do Not Use

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.

When Using

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 • may cause excitability especially in children

Stop Use & Ask a Doctor

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 • 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

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.

Questions

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


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