Drug Facts
Active ingredients (in each liquid-filled capsule)
Solubilized ibuprofen equal to 200 mg ibuprofen USP (NSAID)*
(present as the free acid and potassium salt)
Pseudoephedrine Hydrochloride USP 30 mg
*nonsteroidal anti-inflammatory drug
The following Structured Product Label (SPL) was submitted to the FDA by Cvs Pharmacy, Inc. for the product Ibuprofen And Pseudoephedrine Hcl (NDC 69842-092). 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 liquid-filled capsule)
Solubilized ibuprofen equal to 200 mg ibuprofen USP (NSAID)*
(present as the free acid and potassium salt)
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 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 (1-800-222-1222) right away.
● do not take more than directed
● the smallest effective dose should be used
● adults and children 12 years of age and over:
● take 1 capsule every 4 to 6 hours while symptoms persist. If symptoms do not respond to 1 capsule, 2 capsules may be used.
● do not use more than 6 capsules in any 24-hour period unless directed by a doctor
● children under 12 years of age: do not use
Other information
Black iron oxide, D&C yellow no. 10, gelatin, hypromellose, neelicert FD&C red no. 40, polyethylene glycol, potassium hydroxide, propylene glycol, sorbitol sorbitan solution.
Questions or comments? call 1-855-274-4122
Distributed by:
CVS Pharmacy, Inc.
One CVS Drive
Woonsocket, Rl 02895
© 2019 CVS/pharmacy
CVS.com®
1-800-SHOP CVS
Made in India
Code: TS/DRUGS/22/2009
CVS Health™
Compare to the active
ingredients of Advil® Cold &Sinus**
Non-Drowsy
Cold & Sinus Relief
IBUPROFEN, USP 200 mg - Pain reliever, Fever reducer (NSAID)
PSEUDOEPHEDRINE HCI, USP 30 mg - Nasal decongestant
IBUPROFEN & PSEUDOEPHEDRINE
HCI CAPSULES
Relieves:
• Sinus pressure
• Nasal congestion & Fever
32 LIQUID-FILLED CAPSULES
(4 X 8 CAPSULES PER BLISTER CARD)
* Please review the disclaimer below.