ADVIL SINUS CONGESTION AND PAIN RELIEF- ibuprofen, phenylephrine hydrochloride tablet, coated

Advil Sinus Congestion and Pain Relief by

Drug Labeling and Warnings

Advil Sinus Congestion and Pain 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 ingredient (in each tablet)

Ibuprofen 200 mg (NSAID)*

Phenylephrine HCl 10 mg

*nonsteroidal anti-inflammatory drug

Purpose

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  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  rash  skin reddening  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

 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 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 any other product that contains phenylephrine 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
 the risk of heart attack or stroke may increase if you use more than directed or for longer than directed

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
 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 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

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

acesulfame potassium, artificial flavor, carnauba wax, colloidal silicon dioxide, corn starch, croscarmellose sodium, glycerin, hypromellose, lactic acid, lecithin, maltodextrin, medium-chain triglycerides, microcrystalline cellulose, pharmaceutical ink, polydextrose, polyvinyl alcohol, pregelatinized starch, propyl gallate, sodium lauryl sulfate, stearic acid, 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 SINUS CONGESTION AND PAIN RELIEF 
ibuprofen, phenylephrine hydrochloride tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67751-150(NDC:0573-0199)
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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)
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)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
STEARIC ACID (UNII: 4ELV7Z65AP)
SUCRALOSE (UNII: 96K6UQ3ZD4)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TRIACETIN (UNII: XHX3C3X673)
XANTHAN GUM (UNII: TTV12P4NEE)

Product Characteristics
Color	brown (tan)	Score	no score
Shape	OVAL	Size	15mm
Flavor		Imprint Code	1200;P10
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67751-150-01	1 in 1 CARTON	09/20/2016
1		1 in 1 POUCH; Type 0: Not a Combination Product
2	NDC: 67751-150-02	1 in 1 CARTON	09/20/2016
2		2 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	NDA022565	09/20/2016

Labeler - Navajo Manufacturing Company Inc. (091917799)

Establishment
Name	Address	ID/FEI	Business Operations
Navajo Manufacturing Company Inc.		136941411	relabel(67751-150) , repack(67751-150)