Label: ADVIL ALLERGY AND CONGESTION RELIEF- chlorpheniramine maleate, ibuprofen, phenylephrine hydrochloride tablet, coated
- NDC Code(s): 67751-149-01, 67751-149-02, 67751-149-03
- Packager: Navajo Manufacturing Company Inc.
- This is a repackaged label.
- Source NDC Code(s): 0573-0196
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated March 15, 2023
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Active ingredients (in each tablet)
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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 • 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 directedDo 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 diureticAsk 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 drugWhen 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 childrenStop 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 -
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
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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?
- Package Labeling:
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INGREDIENTS AND APPEARANCE
ADVIL ALLERGY AND CONGESTION RELIEF
chlorpheniramine maleate, ibuprofen, phenylephrine hydrochloride tablet, coatedProduct 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 01/01/2021 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)
