Label: ADVIL ALLERGY CONGESTION RELIEF- chlorpheniramine maleate, ibuprofen, and phenylephrine hydrochloride tablet, coated
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Contains inactivated NDC Code(s)
NDC Code(s): 52904-787-03, 52904-787-04, 52904-787-25, 52904-787-50 - Packager: Select Corporation
- This is a repackaged label.
- Source NDC Code(s): 0573-0196
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated March 23, 2022
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
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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
- minor body aches and pains
- fever
- reduces swelling of the nasal passages
- temporarily restores freer breathing through the nose
- temporarily relieves these symptoms associated with hay fever or other upper respiratory allergies, and the common cold:
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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 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, 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
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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 take 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
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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?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 1 Tablet Pouch Blister Pack
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INGREDIENTS AND APPEARANCE
ADVIL ALLERGY CONGESTION RELIEF
chlorpheniramine maleate, ibuprofen, and phenylephrine hydrochloride tablet, coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52904-787(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, unspecified form (UNII: 33X04XA5AT) egg phospholipids (UNII: 1Z74184RGV) 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) ferric oxide red (UNII: 1K09F3G675) 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:52904-787-03 1 in 1 BLISTER PACK 07/23/2012 1 2 in 1 POUCH; Type 0: Not a Combination Product 2 NDC:52904-787-04 2 in 1 BLISTER PACK 07/23/2012 2 1 in 1 POUCH; Type 0: Not a Combination Product 3 NDC:52904-787-25 25 in 1 CARTON 07/23/2012 3 1 in 1 POUCH; Type 0: Not a Combination Product 4 NDC:52904-787-50 50 in 1 CARTON 07/23/2012 4 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 OTC MONOGRAPH NOT FINAL part343 07/23/2012 Labeler - Select Corporation (053805599)