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Advil Sinus Congestion and Pain Relief

Dosage form: tablet
Ingredients: IBUPROFEN 200mg, PHENYLEPHRINE HYDROCHLORIDE 10mg
Labeler: Navajo Manufacturing Company Inc.
NDC Code: 67751-150

Advil Sinus Congestion & Pain Relief

Drug Facts

Active ingredient (in each tablet)

Ibuprofen 200 mg (NSAID)*

Phenylephrine HCl 10 mg

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever/fever reducer

Nasal decongestant

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

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

• 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

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

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

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.

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

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.

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

Package Labeling:

ADVIL SINUS CONGESTION AND PAIN RELIEF 
ibuprofen, phenylephrine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67751-150(NDC:0573-0199)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (IBUPROFEN) IBUPROFEN200 mg
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE10 mg
Inactive Ingredients
Ingredient NameStrength
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 
Product Characteristics
Colorbrown (tan) Scoreno score
ShapeOVALSize15mm
FlavorImprint Code1200;P10
Contains    
Packaging
#Item CodePackage Description
1NDC:67751-150-011 POUCH in 1 CARTON
11 TABLET in 1 POUCH
2NDC:67751-150-021 POUCH in 1 CARTON
22 TABLET in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02256509/20/2016
Labeler - Navajo Manufacturing Company Inc. (091917799)

 
Navajo Manufacturing Company Inc.

Medically reviewed on Sep 21, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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