Active Ingredients (In Each Tablet)
Chlorpheniramine maleate 4 mg
Ibuprofen 200 mg (NSAID)*
Phenylephrine HCl 10 mg
*nonsteroidal anti-inflammatory drug
The following Structured Product Label (SPL) was submitted to the FDA by Haleon Us Holdings Llc for the product Advil Multi-symptom Cold And Flu (NDC 0573-0190). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients (in each tablet), purposes, indications & usage, warnings, allergy alert: ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. symptoms may include:, stomach bleeding warning: this product contains an nsaid, which may cause severe stomach bleeding. the chance is higher if you:, do not use, ask a doctor before use if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Chlorpheniramine maleate 4 mg
Ibuprofen 200 mg (NSAID)*
Phenylephrine HCl 10 mg
*nonsteroidal anti-inflammatory drug
Antihistamine
Pain reliever/Fever reducer
Nasal decongestant
Uses
Warnings
If an allergic reaction occurs, stop use and seek medical help right away.
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
Other information
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? Call weekdays from 9 AM to 5 PM EST toll free at 1-800-88-ADVIL
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
Advil
MULTI-SYMPTOM
COLD & FLU
Ibuprofen 200 mg Pain Reliever/Fever Reducer (NSAID)
Phenylephrine HCl 10 mg Nasal Decongestant
Chlorpheniramine Maleate 4 mg Antihistamine
ONE
TABLET
DOSE!
30 Coated Tablets
000065883 Carton
* Please review the disclaimer below.