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ADVIL SINUS CONGESTION AND PAIN

Dosage form: tablet, coated
Ingredients: IBUPROFEN 200mg, PHENYLEPHRINE HYDROCHLORIDE 10mg
Labeler: Wyeth Consumer Healthcare LLC
NDC Code: 0573-0199

Advil® Sinus Congestion & Pain

Drug Facts

Active ingredients (in each tablet)Purposes
nonsteroidal anti-inflammatory drug
Ibuprofen 200 mg (NSAID)Pain reliever/fever reducer
Phenylephrine HCl 10 mgNasal 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
  • 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

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
  • 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, 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 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

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
  • 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

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

PRINCIPAL DISPLAY PANEL - 1 Tablet Pouch

Advil®
SINUS CONGESTION & PAIN

Ibuprofen, 200 mg/Phenylephrine HCl, 10 mg
Pain Reliever/Fever Reducer (NSAID)*/Nasal Decongestant

*nonsteroidal anti-inflammatory drug

1 Tablet Non-Drowsy

PRINCIPAL DISPLAY PANEL - 50 Pouch Tray

NON-DROWSY

Advil®

SINUS
CONGESTION & PAIN

Ibuprofen 200 mg Pain Reliever/Fever Reducer (NSAID)
Phenylephrine HCI 10 mg Nasal Decongestant

Nasal Congestion
Headache
Sinus Pressure
Fever
Nasal Swelling
Body Aches

ONE
TABLET
DOSE!

50
Packets of 1
Coated Tablet

PRINCIPAL DISPLAY PANEL - 10 Tablet Blister Pack

Advil®
Sinus Congestion & Pain

Ibuprofen 200 mg /
Phenylephrine HCl 10 mg
See warnings before use.
Pfizer, Madison, NJ 07940 USA

PEEL & PUSH

AREA FOR EXP. & LOT

PRINCIPAL DISPLAY PANEL - 20 Tablet Blister Pack Carton

NON-DROWSY

Advil®

SINUS
CONGESTION & PAIN

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

ONE
TABLET
DOSE!

Nasal Congestion
Headache
Sinus Pressure
Fever
Nasal Swelling
Body Aches

20
Coated
Tablets

ADVIL SINUS CONGESTION AND PAIN 
ibuprofen, phenylephrine hydrochloride tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)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, UNSPECIFIED FORM 
EGG PHOSPHOLIPIDS 
MALTODEXTRIN 
MEDIUM-CHAIN TRIGLYCERIDES 
MICROCRYSTALLINE CELLULOSE 
POLYDEXTROSE 
POLYVINYL ALCOHOL, UNSPECIFIED 
PROPYL GALLATE 
SODIUM LAURYL SULFATE 
STEARIC ACID 
SUCRALOSE 
FERRIC OXIDE RED 
TALC 
TITANIUM DIOXIDE 
TRIACETIN 
XANTHAN GUM 
Product Characteristics
ColorBROWN (tan) Scoreno score
ShapeOVALSize15mm
FlavorImprint Code1200;P10
Contains    
Packaging
#Item CodePackage Description
1NDC:0573-0199-1110 BLISTER PACK in 1 CARTON
11 TABLET, COATED in 1 BLISTER PACK
2NDC:0573-0199-2120 BLISTER PACK in 1 CARTON
21 TABLET, COATED in 1 BLISTER PACK
3NDC:0573-0199-0150 POUCH in 1 TRAY
31 TABLET, COATED in 1 POUCH
4NDC:0573-0199-2230 BLISTER PACK in 1 CARTON
41 TABLET, COATED in 1 BLISTER PACK
5NDC:0573-0199-033000 POUCH in 1 CARTON
51 TABLET, COATED in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02256507/01/2015
Labeler - Wyeth Consumer Healthcare LLC (828831730)
Registrant - Pfizer Inc (113480771)
Establishment
NameAddressID/FEIOperations
Wyeth Pharmaceuticals Company829390975ANALYSIS(0573-0199), LABEL(0573-0199), MANUFACTURE(0573-0199), PACK(0573-0199)
Establishment
NameAddressID/FEIOperations
Wyeth Consumer Healthcare LLC828831730ANALYSIS(0573-0199), MANUFACTURE(0573-0199)

 
Wyeth Consumer Healthcare LLC

Medically reviewed on Jun 26, 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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