Advil Sinus Congestion & Pain Relief

Advil Sinus Congestion & Pain Relief
SPL v3
SPL
SPL Set ID 531abadc-37fd-4953-95bc-a211a2ba6914
Route
ORAL
Published
Effective Date 2016-09-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Ibuprofen (200 mg) Phenylephrine (10 mg)
Inactive Ingredients
Acesulfame Potassium Carnauba Wax Silicon Dioxide Starch, Corn Croscarmellose Sodium Glycerin Hypromellose, Unspecified Lactic Acid Maltodextrin Medium-chain Triglycerides Microcrystalline Cellulose Polydextrose Polyvinyl Alcohol, Unspecified Propyl Gallate Sodium Lauryl Sulfate Stearic Acid Sucralose Talc Titanium Dioxide Triacetin Xanthan Gum

Identifiers & Packaging

Pill Appearance
Imprint: 1200;P10 Shape: oval Color: brown Size: 15 mm Score: 1
Marketing Status
NDA Active Since 2016-09-20

Description

Ibuprofen 200 mg (NSAID)* Phenylephrine HCl 10 mg *nonsteroidal anti-inflammatory drug

Purpose

Pain reliever/fever reducer Nasal decongestant


Medication Information

Purpose

Pain reliever/fever reducer

Nasal decongestant

Description

Ibuprofen 200 mg (NSAID)* Phenylephrine HCl 10 mg *nonsteroidal anti-inflammatory drug

Uses

• temporarily relieves these symptoms associated with the common cold or flu:

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

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 • rash • skin reddening • 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

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

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

Other Information

• store at 20-25°C (68-77°F)

• avoid excessive heat above 40°C (104°F).

• read all warnings and directions before use. Keep carton.

Package Labeling:

Inactive Ingredients

acesulfame potassium, artificial flavor, carnauba wax, colloidal silicon dioxide, corn starch, croscarmellose sodium, glycerin, hypromellose, lactic acid, lecithin, maltodextrin, medium-chain triglycerides, microcrystalline cellulose, pharmaceutical ink, polydextrose, polyvinyl alcohol, pregelatinized starch, propyl gallate, sodium lauryl sulfate, stearic acid, 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

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

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, thyroid disease, diabetes or have trouble urinating due to an enlarged prostate gland

• you are taking a diuretic

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

• symptoms continue or get worse

• redness or swelling is present in the painful area

• you get nervous, dizzy, or sleepless

• 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.

Active Ingredient (in Each Tablet)

Ibuprofen 200 mg (NSAID)*

Phenylephrine HCl 10 mg

*nonsteroidal anti-inflammatory drug

Ask A Doctor Or Pharmacist Before Use If You Are

• under a doctor's care for any serious condition

• taking any other product that contains phenylephrine or any other nasal decongestant

• taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin

• taking any other drug


Structured Label Content

Uses

• temporarily relieves these symptoms associated with the common cold or flu:

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

Purpose

Pain reliever/fever reducer

Nasal decongestant

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 • rash • skin reddening • 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

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

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

Other Information (Other information)

• store at 20-25°C (68-77°F)

• avoid excessive heat above 40°C (104°F).

• read all warnings and directions before use. Keep carton.

Package Labeling:

Inactive Ingredients (Inactive ingredients)

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

Questions Or Comments? (Questions or comments?)

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

When Using This Product (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

Ask A Doctor Before Use If (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, thyroid disease, diabetes or have trouble urinating due to an enlarged prostate gland

• you are taking a diuretic

Stop Use and Ask A Doctor If (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

• symptoms continue or get worse

• redness or swelling is present in the painful area

• you get nervous, dizzy, or sleepless

• any new symptoms appear

If Pregnant 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.

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.

Active Ingredient (in Each Tablet) (Active ingredient (in each tablet))

Ibuprofen 200 mg (NSAID)*

Phenylephrine HCl 10 mg

*nonsteroidal anti-inflammatory drug

Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)

• under a doctor's care for any serious condition

• taking any other product that contains phenylephrine or any other nasal decongestant

• taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin

• taking any other drug


Advanced Ingredient Data


Raw Label Data

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