ADVIL ALLERGY AND CONGESTION RELIEF- chlorpheniramine maleate, ibuprofen, and phenylephrine hydrochloride tablet, coated 
Wyeth Consumer Healthcare LLC

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Advil®
ALLERGY & CONGESTION RELIEF

Drug Facts

Active ingredients
(in each tablet)
Purposes
*
nonsteroidal anti-inflammatory drug
Chlorpheniramine maleate 4 mgAntihistamine
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
  • asthma (wheezing)
  • skin reddening
  • blisters
  • facial swelling
  • shock
  • rash

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

  • you have a breathing problem such as emphysema or chronic bronchitis
  • 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, glaucoma, 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 sedatives or tranquilizers
  • taking any other product that contains phenylephrine, chlorpheniramine or any other nasal decongestant or antihistamine
  • 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
  • avoid alcoholic drinks
  • be careful when driving a motor vehicle or operating machinery
  • drowsiness may occur
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • may cause excitability especially in children

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
  • redness or swelling is present in the painful area
  • you get nervous, dizzy, or sleepless
  • symptoms continue or get worse
  • 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 flavors, carnauba wax, colloidal silicon dioxide, corn starch, croscarmellose sodium, glycerin, glycreyl dibehenate, hypromellose, lactic acid, lecithin, maltodextrin, medium-chain triglycerides, microcrystalline cellulose, pharmaceutical ink, polydextrose, polyvinyl alcohol, pregelatinized starch, propyl gallate, silicon dioxide, 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

PRINCIPAL DISPLAY PANEL - 1 Tablet Packet

TO OPEN: FOLD BACK ON DOTTED LINE.
TEAR ON ARROW OR USE SCISSORS.
Do Not Use if pouch is broken or torn.

Advil®

ALLERGY & CONGESTION RELIEF

Chlorpheniramine Maleate 4 mg
Antihistamine
Ibuprofen 200 mg (NSAID)*
Pain reliever/Fever reducer
Phenylephrine HCl 10 mg
Nasal decongestant

1 Tablet

*nonsteroidal anti-inflammatory drug

PAA080418

Principal Display Panel - 1 Tablet Packet

PRINCIPAL DISPLAY PANEL - 50 Packet Tray

Advil®

ALLERGY & CONGESTION RELIEF

Chlorpheniramine Maleate 4 mg Antihistamine
Ibuprofen 200 mg Pain Reliever/Fever Reducer
(NSAID)
Phenylephrine HCl 10 mg Nasal Decongestant

1
PILL
DOSAGE

Advil
A&CR

Relief of: Sinus Pressure, Nasal Swelling &
Congestion, Sneezing, Runny Nose and Headache

50 PACKETS OF 1 COATED TABLET

PRINCIPAL DISPLAY PANEL - 50 Packet Tray

PRINCIPAL DISPLAY PANEL - 10 Tablet Blister Pack Carton

Advil®

ALLERGY &
CONGESTION RELIEF

Chlorpheniramine Maleate 4 mg Antihistamine
Ibuprofen 200 mg Pain Reliever/Fever Reducer (NSAID)
Phenylephrine HCl 10 mg Nasal Decongestant

Advil
A&CR

ONE
PILL
DOSE!

10
Coated
Tablets

Sneezing
Nasal Congestion
Sinus Pressure
Nasal Swelling
Runny Nose
Headache
Fever
Body Aches
PRINCIPAL DISPLAY PANEL - 10 Tablet Blister Pack Carton

PRINCIPAL DISPLAY PANEL - 2 Tablet Packet Carton

Advil®

ALLERGY &
CONGESTION RELIEF

Chlorpheniramine Maleate 4 mg Antihistamine
Ibuprofen 200 mg Pain Reliever/Fever Reducer (NSAID)
Phenylephrine HCl 10 mg Nasal Decongestant

Sneezing
Nasal Congestion
Sinus Pressure
Nasal Swelling
Runny Nose
Headache
Fever
Body Aches

ONE
TABLET
DOSE!

2
Packets of 1
Coated Tablet

PRINCIPAL DISPLAY PANEL - 2 Tablet Packet Carton

PRINCIPAL DISPLAY PANEL - 30 Tablet Blister Pack Carton

50%
MORE
10 FREE
Tablets

Advil®

ALLERGY &
CONGESTION RELIEF

Chlorpheniramine Maleate 4 mg Antihistamine
Ibuprofen 200 mg Pain Reliever/Fever Reducer (NSAID)
Phenylephrine HCl 10 mg Nasal Decongestant

Sneezing
Nasal Congestion
Sinus Pressure
Nasal Swelling
Runny Nose
Headache
Fever
Body Aches

ONE
TABLET
DOSE!

30
Coated
Tablets

PRINCIPAL DISPLAY PANEL - 30 Tablet Blister Pack Carton
ADVIL ALLERGY AND CONGESTION RELIEF 
chlorpheniramine maleate, ibuprofen, and phenylephrine hydrochloride tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0573-0196
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE4 mg
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)  
GLYCERYL DIBEHENATE (UNII: R8WTH25YS2)  
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)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TRIACETIN (UNII: XHX3C3X673)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Product Characteristics
ColorGRAYScoreno score
ShapeOVALSize17mm
FlavorImprint Code Advil;A;CR
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0573-0196-0150 in 1 TRAY07/23/2012
11 in 1 PACKET; Type 0: Not a Combination Product
2NDC:0573-0196-101 in 1 CARTON07/23/2012
210 in 1 BLISTER PACK; Type 0: Not a Combination Product
3NDC:0573-0196-202 in 1 CARTON07/23/2012
310 in 1 BLISTER PACK; Type 0: Not a Combination Product
4NDC:0573-0196-022 in 1 CARTON10/01/2019
41 in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02211307/23/2012
ADVIL ALLERGY AND CONGESTION RELIEF 
chlorpheniramine maleate, ibuprofen, and phenylephrine hydrochloride tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0573-2161
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE4 mg
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)  
GLYCERYL DIBEHENATE (UNII: R8WTH25YS2)  
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)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TRIACETIN (UNII: XHX3C3X673)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Product Characteristics
ColorGRAYScoreno score
ShapeOVALSize17mm
FlavorImprint Code Advil;A;CR
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0573-2161-032 in 1 CARTON10/01/2019
110 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02211307/23/2012
Labeler - Wyeth Consumer Healthcare LLC (828831730)
Establishment
NameAddressID/FEIBusiness Operations
Wyeth Pharmaceuticals Company829390975ANALYSIS(0573-0196, 0573-2161) , LABEL(0573-0196, 0573-2161) , MANUFACTURE(0573-0196, 0573-2161) , PACK(0573-0196, 0573-2161)

Revised: 10/2019
Document Id: 3439c425-e2f4-416d-9a0d-20a4475d83ea
Set id: a6cc97d8-252a-4527-a470-6d9e356342fd
Version: 8
Effective Time: 20191017
 
Wyeth Consumer Healthcare LLC