ADVIL COLD AND SINUS- ibuprofen, pseudoephedrine hydrochloride capsule, liquid filled 
Haleon US Holdings LLC

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Drug Facts

Active ingredients (in each liquid-filled capsule)

Solubilized ibuprofen equal to 200 mg ibuprofen (NSAID)*

(present as the free acid and potassium salt)

Pseudoephedrine HCl 30 mg

*nonsteroidal anti-inflammatory drug

Purposes

Pain reliever/fever reducer

Nasal decongestant

Uses

temporarily relieves these symptoms associated with the common cold or flu:

headache
fever
sinus pressure
nasal congestion
minor body aches and pains

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

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 pseudoephedrine 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
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
the smallest effective dose should be used
adults and children 12 years of age and over:
take 1 capsule every 4 to 6 hours while symptoms persist. If symptoms do not respond to 1 capsule, 2 capsules may be used.
do not use more than 6 capsules in any 24-hour period unless directed by a doctor
children under 12 years of age: do not use

Other information

each capsule contains: potassium 20 mg
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

D&C yellow no. 10, FD&C red no. 40, gelatin, medium-chain triglycerides, pharmaceutical ink, polyethylene glycol, potassium hydroxide, purified water, sorbitol sorbitan solution

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.

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

Distributed by: GSK Consumer Healthcare, Warren, NJ 07059

Trademarks owned or licensed by GSK ©2021 GSK or licensor

LIQUI-GELS® is a trademark or registered trademark of Catalent Pharma Solutions.

PRINCIPAL DISPLAY PANEL

Advil

COLD & SINUS Non-Drowsy

Ibuprofen 200 mg ‣ Pain Reliever/Fever Reducer (NSAID)

Pseudoephedrine HCl 30 mg ‣ Nasal Decongestant

Relieves Sinus Pressure,
Nasal Congestion and Fever

LIQUI-GELS ®

Advil
C & S

32 LIQUID-FILLED CAPSULES

000065783 Carton

Advil Cold & Sinus Liqui-Gels 200mg 30mg Blister Pack Carton
ADVIL COLD AND SINUS 
ibuprofen, pseudoephedrine hydrochloride capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0573-0184
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN200 mg
PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE30 mg
Inactive Ingredients
Ingredient NameStrength
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
SORBITAN (UNII: 6O92ICV9RU)  
Product Characteristics
ColorORANGEScoreno score
ShapeOVALSize15mm
FlavorImprint Code Advil;C;S
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0573-0184-3232 in 1 CARTON05/30/2002
11 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:0573-0184-1616 in 1 CARTON05/30/2002
21 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02137405/30/2002
Labeler - Haleon US Holdings LLC (079944263)

Revised: 1/2024
Document Id: a7adc69e-8021-4e0c-a28f-c3f689bd2f5a
Set id: 0da9ed22-bfb4-d61b-110b-0c7760332a98
Version: 11
Effective Time: 20240126
 
Haleon US Holdings LLC