ADVIL MULTI-SYMPTOM COLD AND FLU- chlorpheniramine maleate, ibuprofen, phenylephrine hcl tablet, coated 
Haleon US Holdings LLC

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Advil MultiSymptom Cold and Flu NDC 0573-0190

Active ingredients (in each tablet)

Chlorpheniramine maleate 4 mg

Ibuprofen 200 mg (NSAID)*

Phenylephrine HCl 10 mg

*nonsteroidal anti-inflammatory drug

Purposes

Antihistamine

Pain reliever/Fever reducer

Nasal 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
  • 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 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

Other information

Inactive ingredients

acesulfame potassium, artificial flavors, carnauba wax, colloidal silicon dioxide, corn starch, croscarmellose sodium, glycerin, glyceryl 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 ESTtoll 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

MULTI-SYMPTOM
COLD & FLU

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

ONE
TABLET
DOSE!

30Coated Tablets

000065883 Carton

Advil MultiSymptom Cold & Flu 30 Coated Tablets
ADVIL MULTI-SYMPTOM COLD AND FLU 
chlorpheniramine maleate, ibuprofen, phenylephrine hcl tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0573-0190
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)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
GLYCERIN (UNII: PDC6A3C0OX)  
GLYCERYL DIBEHENATE (UNII: R8WTH25YS2)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT)  
SOYBEAN LECITHIN (UNII: 1DI56QDM62)  
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)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TRIACETIN (UNII: XHX3C3X673)  
XANTHAN GUM (UNII: TTV12P4NEE)  
STARCH, CORN (UNII: O8232NY3SJ)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
Product Characteristics
ColorgrayScoreno score
ShapeOVALSize17mm
FlavorImprint Code Advil;CF
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0573-0190-101 in 1 CARTON06/25/2018
110 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:0573-0190-202 in 1 CARTON06/25/2018
210 in 1 BLISTER PACK; Type 0: Not a Combination Product
3NDC:0573-0190-0150 in 1 TRAY06/25/2018
31 in 1 POUCH; Type 0: Not a Combination Product
4NDC:0573-0190-303 in 1 CARTON06/25/2018
410 in 1 BLISTER PACK; Type 0: Not a Combination Product
5NDC:0573-0190-033000 in 1 CASE06/25/2018
51 in 1 POUCH; Type 0: Not a Combination Product
6NDC:0573-0190-022 in 1 CARTON11/01/2019
61 in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02211306/25/2018
Labeler - Haleon US Holdings LLC (079944263)
Establishment
NameAddressID/FEIBusiness Operations
PF Consumer Healthcare B.V. (Puerto Rico Operations) LLC118346012analysis(0573-0190) , label(0573-0190) , manufacture(0573-0190) , pack(0573-0190)

Revised: 10/2025
Document Id: 4042cf07-a239-1ae9-e063-6394a90acd01
Set id: 7671d104-3c5c-4f63-b6b1-6c91c22592f8
Version: 14
Effective Time: 20251003
 
Haleon US Holdings LLC