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Drug Facts
The following Structured Product Label (SPL) was submitted to the FDA by Haleon Us Holdings Llc for the product Advil Sinus Congestion And Pain (NDC 0573-0199). 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 other, otc - purpose, indications & usage, warnings, allergy alert, stomach bleeding 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.
Drug Facts
| Active ingredients (in each tablet) | Purposes |
|---|---|
| Ibuprofen 200 mg (NSAID) nonsteroidal anti-inflammatory drug | Pain reliever/fever reducer |
| Phenylephrine HCl 10 mg | Nasal decongestant |
Uses
Warnings
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:
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
Other information
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
For most recent product information, visit www.advil.com
Advil®
SINUS CONGESTION & PAIN
Ibuprofen, 200 mg/Phenylephrine HCl, 10 mg
Pain Reliever/Fever Reducer (NSAID)*/Nasal Decongestant
*nonsteroidal anti-inflammatory drug
1 Tablet Non-Drowsy
NON-DROWSY
Advil®
SINUS
CONGESTION & PAIN
Ibuprofen 200 mg Pain Reliever/Fever Reducer (NSAID)
Phenylephrine HCI 10 mg Nasal Decongestant
ONE
TABLET
DOSE!
50
Packets of 1
Coated Tablet
Advil®
Sinus Congestion & Pain
Ibuprofen 200 mg /
Phenylephrine HCl 10 mg
See warnings before use.
Pfizer, Madison, NJ 07940 USA
PEEL & PUSH
AREA FOR EXP. & LOT
NON-DROWSY
Advil®
SINUS
CONGESTION & PAIN
Ibuprofen 200 mg Pain Reliever/Fever Reducer (NSAID)
Phenylephrine HCl 10 mg Nasal Decongestant
ONE
TABLET
DOSE!
20
Coated
Tablets
* Please review the disclaimer below.