ADVIL SINUS CONGESTION AND PAIN- ibuprofen, phenylephrine hydrochloride tablet, coated 
Haleon US Holdings LLC

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Drug Facts

Active ingredients (in each tablet)

Ibuprofen 200 mg (NSAID)*

Phenylephrine HCl 10 mg

*nonsteroidal anti-inflammatory drug

Purposes

Pain reliever/fever reducer

Nasal decongestant

Uses

temporarily relieves these symptoms associated with the common cold or flu:
o
headache
o
fever
o
sinus pressure
o
nasal congestion
o
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:
o
feel faint
o
vomit blood
o
have bloody or black stools
o
have stomach pain that does not get better
you have symptoms of heart problems or stroke:
o
chest pain
o
trouble breathing
o
weakness in one part or side of body
o
slurred speech
o
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 at 20 weeks or later in 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:
o
take 1 tablet every 4 hours while symptoms persist.
o
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

Additional Information

READ AND KEEP CARTON FOR COMPLETE
WARNINGS AND INFORMATION

Product inside sealed in plastic blister with foil backing.
Do Not Use if plastic blister or foil barrier is broken.

Distributed by: GSK Consumer Healthcare, Warren, NJ 07059

For most recent product information,

visit www.advil.com

Trademarks owned or licensed by GSK ©2021 GSK or licensor

PRINCIPAL DISPLAY PANEL

Advil

NON-DROWSY

SINUS
CONGESTION & PAIN

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

Nasal Congestion
Headache
Sinus Pressure
Fever
Nasal Swelling
Body Aches

ONE
TABLET
DOSE!

1200-P10

30 Coated Tablets

000065893

Advil Sinus Congestion & Pain 30 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 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
ColorBROWN (tan) Scoreno score
ShapeOVALSize15mm
FlavorImprint Code 1200;P10
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0573-0199-1110 in 1 CARTON07/01/2015
11 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:0573-0199-2120 in 1 CARTON07/01/2015
21 in 1 BLISTER PACK; Type 0: Not a Combination Product
3NDC:0573-0199-0150 in 1 TRAY07/01/2015
31 in 1 POUCH; Type 0: Not a Combination Product
4NDC:0573-0199-2230 in 1 CARTON11/02/2015
41 in 1 BLISTER PACK; Type 0: Not a Combination Product
5NDC:0573-0199-033000 in 1 CARTON07/01/2015
51 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 - Haleon US Holdings LLC (079944263)
Establishment
NameAddressID/FEIBusiness Operations
PF Consumer Healthcare B.V. (Puerto Rico Operations) LLC118346012ANALYSIS(0573-0199) , LABEL(0573-0199) , MANUFACTURE(0573-0199) , PACK(0573-0199)

Revised: 1/2024
Document Id: aecbb0f8-a578-4c83-831a-052efd98d78f
Set id: b1e29c19-fe03-4d2b-b966-0adf4eb4b4cf
Version: 11
Effective Time: 20240131
 
Haleon US Holdings LLC