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Advil Cold and Sinus

Package insert / prescribing information
Generic name: ibuprofen, pseudoephedrine hydrochloride
Dosage form: tablet, coated
Drug class: Upper respiratory combinations

Medically reviewed by Drugs.com. Last updated on Jul 1, 2021.

Active ingredients (in each caplet)

Ibuprofen 200 mg (NSAID)*

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 caplet every 4 to 6 hours while symptoms persist. If symptoms do not respond to 1 caplet, 2 caplets may be used.
do not use more than 6 caplets in any 24-hour period unless directed by a doctor
children under 12 years of age: do not use

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

acetylated monoglycerides, carnauba wax, colloidal silicon dioxide, corn starch, croscarmellose sodium, methylparaben, microcrystalline cellulose, pharmaceutical glaze, pharmaceutical ink, povidone, pregelatinized starch, propylparaben, sodium benzoate, sodium lauryl sulfate, stearic acid, sucrose, synthetic iron oxides, titanium dioxide

Questions or comments? call toll free 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

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

ADVIL
COLD&SINUS

20 COATED CAPLETS*

*Oval-Shaped Tablets

000065881 Carton

Advil Cold and Sinus
ibuprofen and pseudoephedrine hydrochloride tablet, coated
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0573-0180
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
IBUPROFEN (IBUPROFEN) IBUPROFEN 200 mg
PSEUDOEPHEDRINE HYDROCHLORIDE (PSEUDOEPHEDRINE) PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg
Inactive Ingredients
Ingredient Name Strength
DIACETYLATED MONOGLYCERIDES
CARNAUBA WAX
SILICON DIOXIDE
STARCH, CORN
CROSCARMELLOSE SODIUM
METHYLPARABEN
MICROCRYSTALLINE CELLULOSE
SHELLAC
POVIDONE, UNSPECIFIED
PROPYLPARABEN
SODIUM BENZOATE
SODIUM LAURYL SULFATE
STEARIC ACID
SUCROSE
FERRIC OXIDE RED
TITANIUM DIOXIDE
Product Characteristics
Color BROWN (butterscotch) Score no score
Shape OVAL (oblong) Size 14mm
Flavor Imprint Code Advil;Cold;Sinus
Contains
Packaging
# Item Code Package Description
1 NDC:0573-0180-10 2 BLISTER PACK in 1 CARTON
1 10 TABLET, COATED in 1 BLISTER PACK
2 NDC:0573-0180-21 4 BLISTER PACK in 1 CARTON
2 10 TABLET, COATED in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA019771 09/19/1989
Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)
Establishment
Name Address ID/FEI Operations
Wyeth Pharmaceuticals Company 829390975 ANALYSIS(0573-0180), MANUFACTURE(0573-0180)
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC

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