Drug Facts
Active ingredients (in each caplet)
Ibuprofen USP 200 mg (NSAID)*
Pseudoephedrine hydrochloride USP 30 mg
*nonsteroidal anti-inflammatory drug
The following Structured Product Label (SPL) was submitted to the FDA by Aurohealth Llc for the product Ibuprofen And Pseudoephedrine Hydrochloride (NDC 58602-839). 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 drug facts, purposes, uses, warnings, do not use, ask a doctor before use if, ask a doctor or pharmacist before use if you are, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Active ingredients (in each caplet)
Ibuprofen USP 200 mg (NSAID)*
Pseudoephedrine hydrochloride USP 30 mg
*nonsteroidal anti-inflammatory drug
Pain reliever/fever reducer
Nasal decongestant
temporarily relieves these symptoms associated with the common cold or flu:
Allergy alert: 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.
Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:
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.
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.
In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Other information
colloidal silicon dioxide, corn starch, croscarmellose sodium, glyceryl monocaprylocaprate type 1, iron oxide red, iron oxide yellow, microcrystalline cellulose, polyvinyl alcohol-part. hydrolyzed, pregelatinized starch (maize), sodium lauryl sulfate, stearic acid, talc and titanium dioxide.
Questions or comments? call 1-855-274-4122
(Monday - Friday 8:30 AM to 5:00 PM EST)
Distributed by:
AUROHEALTH LLC
279 Princeton-Hightstown Road
East Windsor, NJ 08520
Made in India
Code: TS/DRUGS/22/2009
AUROHEALTH
NDC 58602-839-13
#Compare to the active
ingredients of Advil® Cold &Sinus
Non-Drowsy
COLD & SINUS RELIEF
Ibuprofen and Pseudoephedrine
Hydrochloride Tablets USP 200 mg/30 mg
Ibuprofen USP 200 mg - Pain Reliever/Fever Reducer (NSAID)
Pseudoephedrine Hydrochloride USP 30 mg - Nasal Decongestant
32 Coated Caplets†
†Oval-Shaped tablets
* Please review the disclaimer below.