ADVIL ALLERGY AND CONGESTION RELIEF- chlorpheniramine maleate, ibuprofen, phenylephrine hydrochloride tablet, coated

Advil Allergy and Congestion Relief by

Drug Labeling and Warnings

Advil Allergy and Congestion Relief by is a Otc medication manufactured, distributed, or labeled by Navajo Manufacturing Company Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

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

temporarily relieves these symptoms associated with hay fever or other upper respiratory allergies, and the common cold:
runny nose itchy, watery eyes itching of the nose or throat
sneezing nasal congestion sinus pressure
headache fever 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

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 or have trouble urinating due to an enlarged prostate gland 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
the risk of heart attack or stroke may increase if you use more than directed or for longer than directed 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
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

do not take more than directed
adults and children 12 years of age and over:
take 1 tablet every 4 hours while symptoms persist
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

read all warnings and directions before use. Keep Carton.
store at 20-25°C (68-77°F) avoid excessive heat above 40°C (104°F)

​Inactive ingredients

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

Package Labeling:

INGREDIENTS AND APPEARANCE

ADVIL ALLERGY AND CONGESTION RELIEF 
chlorpheniramine maleate, ibuprofen, phenylephrine hydrochloride tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67751-149(NDC:0573-0196)
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U)	CHLORPHENIRAMINE MALEATE	4 mg
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM)	IBUPROFEN	200 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	10 mg

Inactive Ingredients
Ingredient Name	Strength
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 (UNII: 33X04XA5AT)
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)

Product Characteristics
Color	gray	Score	no score
Shape	OVAL	Size	17mm
Flavor		Imprint Code	Advil;A;CR
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67751-149-01	1 in 1 CARTON	09/16/2016
1		1 in 1 POUCH; Type 0: Not a Combination Product
2	NDC: 67751-149-02	2 in 1 CARTON	09/16/2016
2		1 in 1 POUCH; Type 0: Not a Combination Product
3	NDC: 67751-149-03	12 in 1 TRAY	09/16/2016
3		1 in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA022113	09/16/2016

Labeler - Navajo Manufacturing Company Inc. (091917799)

Establishment
Name	Address	ID/FEI	Business Operations
Navajo Manufacturing Company Inc.		136941411	relabel(67751-149) , repack(67751-149)