ADVIL CONGESTION RELIEF

Dosage form: tablet, film coated
Ingredients: IBUPROFEN 200mg, PHENYLEPHRINE HYDROCHLORIDE 10mg
Labeler: Pfizer Consumer Healthcare
NDC Code: 0573-0195

Advil Congestion Relief
[Ibuprofen and Phenylephrine HCl]

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

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

Pfizer, Madison, NJ 07940 USA

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

PRINCIPAL DISPLAY PANEL - 10 Tablet Blister Pack

Advil®

CONGESTION RELIEF

Ibuprofen 200 mg /
Phenylephrine HCl 10 mg

See warnings before use.

Pfizer, Madison, NJ 07940 USA

AREA FOR EXP. & LOT

PEEL & PUSH

PRINCIPAL DISPLAY PANEL - 50 Tablet Carton

CONTAINS:
Ibuprofen & Phenylephrine

Advil®

CONGESTION RELIEF

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

1
PILL
DOSAGE

NON-DROWSY relief of: Sinus Pressure,
Nasal Swelling & Congestion, and Headache

50
COATED
TABLETS

PRINCIPAL DISPLAY PANEL - 1 Tablet Pouch

Advil® CONGESTION RELIEF

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

CONTAINS:
Ibuprofen & Phenylephrine

Advil®

CONGESTION RELIEF

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

1
PILL
DOSAGE

NON-DROWSY relief of: Sinus Pressure,
Nasal Swelling & Congestion, and Headache

50 PACKETS OF 1 COATED TABLET

ADVIL CONGESTION RELIEF 
ibuprofen and phenylephrine hydrochloride tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0573-0195
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 
CROSCARMELLOSE SODIUM 
GLYCERIN 
HYPROMELLOSES 
EGG PHOSPHOLIPIDS 
MALTODEXTRIN 
MEDIUM-CHAIN TRIGLYCERIDES 
POLYDEXTROSE 
POLYVINYL ALCOHOL 
PROPYL GALLATE 
STEARIC ACID 
SODIUM LAURYL SULFATE 
STARCH, CORN 
SUCRALOSE 
TALC 
TITANIUM DIOXIDE 
TRIACETIN 
XANTHAN GUM 
CELLULOSE, MICROCRYSTALLINE 
Product Characteristics
ColorBROWN (slightly, glossy tan) Scoreno score
ShapeOVAL (oval shaped tablet) Size15mm
FlavorImprint Code1200;P10
Contains    
Packaging
#Item CodePackage Description
1NDC:0573-0195-101 BLISTER PACK in 1 CARTON
110 TABLET, FILM COATED in 1 BLISTER PACK
2NDC:0573-0195-202 BLISTER PACK in 1 CARTON
210 TABLET, FILM COATED in 1 BLISTER PACK
3NDC:0573-0195-414 BLISTER PACK in 1 CARTON
310 TABLET, FILM COATED in 1 BLISTER PACK
4NDC:0573-0195-505 BLISTER PACK in 1 CARTON
410 TABLET, FILM COATED in 1 BLISTER PACK
5NDC:0573-0195-0150 POUCH in 1 TRAY
51 TABLET, FILM COATED in 1 POUCH
6NDC:0573-0195-033000 POUCH in 1 TRAY
61 TABLET, FILM COATED in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02256510/04/2010
Labeler - Pfizer Consumer Healthcare (828831730)
Establishment
NameAddressID/FEIOperations
Wyeth Pharmaceuticals Company, Consumer Site829390975ANALYSIS(0573-0195), LABEL(0573-0195), MANUFACTURE(0573-0195), PACK(0573-0195)

Revised: 07/2013
 
Pfizer Consumer Healthcare

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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