Active Ingredients (In Each Caplet)
Ibuprofen 200 mg (NSAID)*
Pseudoephedrine HCl 30 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 Cold And Sinus (NDC 0573-2160). 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 caplet), purposes, uses, allergy alert:, stomach bleeding warning:, heart attack and stroke warning, 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.
Ibuprofen 200 mg (NSAID)*
Pseudoephedrine HCl 30 mg
*nonsteroidal anti-inflammatory drug
Pain reliever/fever reducer
Nasal decongestant
temporarily relieves these symptoms associated with the common cold or flu:
Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:
If an allergic reaction occurs, stop use and seek medical help right away.
This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:
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.
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.
In case of overdose, get medical help or contact a Poison Control Center right away.
acetylated monoglycerides, carnauba wax, colloidal silicon dioxide, corn starch, croscarmellose sodium, methylparaben, microcrystalline cellulose, pharmaceutical glaze, pharmaceutical ink, povidone, pregelatinized starch, propylparaben, sodium benzoate, sodium lauryl sulfate, stearic acid, sucrose, synthetic iron oxides, titanium dioxide
Call toll free 1-800-88-ADVIL
Advil®
COLD & SINUS Non-Drowsy
Ibuprofen 200 mg ‣ Pain Reliever/Fever Reducer (NSAID)
Pseudoephedrine HCl 30 mg ‣ Nasal Decongestant
Relieves Sinus Pressure,
Nasal Congestion and Fever
40
COATED
CAPLETS*
*Oval-Shaped Tablets
* Please review the disclaimer below.