ADVIL SINUS CONGESTION AND PAIN- ibuprofen, phenylephrine hydrochloride tablet, coated 
Select Corporation

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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

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

Other information

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

Product Repackaged and Distributed
with permission of Pfizer Consumer Healthcare by:
Select Corporation Carrollton, TX 75007

PRINCIPAL DISPLAY PANEL - 1 Tablet Pouch Blister Pack

NON-DROWSY

Advil®

SINUS
CONGESTION & PAIN

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

ONE
TALBET
DOSE!

1 PACKET OF
1 COATED TABLET

PRINCIPAL DISPLAY PANEL - 1 Tablet Pouch Blister Pack
ADVIL SINUS CONGESTION AND PAIN 
ibuprofen, phenylephrine hydrochloride tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52904-782(NDC:0573-0199)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Ibuprofen (UNII: WK2XYI10QM) (ibuprofen - UNII:WK2XYI10QM) Ibuprofen200 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg
Inactive Ingredients
Ingredient NameStrength
acesulfame potassium (UNII: 23OV73Q5G9)  
carnauba wax (UNII: R12CBM0EIZ)  
silicon dioxide (UNII: ETJ7Z6XBU4)  
STARCH, CORN (UNII: O8232NY3SJ)  
croscarmellose sodium (UNII: M28OL1HH48)  
glycerin (UNII: PDC6A3C0OX)  
hypromellose, unspecified (UNII: 3NXW29V3WO)  
lactic acid, unspecified form (UNII: 33X04XA5AT)  
egg phospholipids (UNII: 1Z74184RGV)  
maltodextrin (UNII: 7CVR7L4A2D)  
medium-chain triglycerides (UNII: C9H2L21V7U)  
microcrystalline cellulose (UNII: OP1R32D61U)  
polydextrose (UNII: VH2XOU12IE)  
polyvinyl alcohol, unspecified (UNII: 532B59J990)  
propyl gallate (UNII: 8D4SNN7V92)  
sodium lauryl sulfate (UNII: 368GB5141J)  
stearic acid (UNII: 4ELV7Z65AP)  
sucralose (UNII: 96K6UQ3ZD4)  
ferric oxide red (UNII: 1K09F3G675)  
talc (UNII: 7SEV7J4R1U)  
titanium dioxide (UNII: 15FIX9V2JP)  
triacetin (UNII: XHX3C3X673)  
xanthan gum (UNII: TTV12P4NEE)  
Product Characteristics
ColorBROWNScoreno score
ShapeOVALSize15mm
FlavorImprint Code 1200;P10
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52904-782-031 in 1 BLISTER PACK07/01/2015
11 in 1 POUCH; Type 0: Not a Combination Product
2NDC:52904-782-042 in 1 BLISTER PACK07/01/2015
21 in 1 POUCH; Type 0: Not a Combination Product
3NDC:52904-782-2525 in 1 CARTON07/01/2015
31 in 1 POUCH; Type 0: Not a Combination Product
4NDC:52904-782-5050 in 1 CARTON07/01/2015
41 in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02256507/01/2015
Labeler - Select Corporation (053805599)

Revised: 4/2022
Document Id: bf8fc6fa-d880-4cd1-a815-1d3ad3cd955e
Set id: dc7ebdf5-52f1-4341-a2cb-c96fa6272dd9
Version: 2
Effective Time: 20220412
 
Select Corporation