Active Ingredients (In Each Caplet)
Acetaminophen 325 mg
Guaifenesin 200 mg
Phenylephrine HCl 5 mg
The following Structured Product Label (SPL) was submitted to the FDA by Cvs Pharmacy for the product Severe Sinus Pain And Congestion (NDC 59779-275). 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), purpose, uses, warnings, do not use, ask a doctor before use if you have, 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.
Acetaminophen 325 mg
Guaifenesin 200 mg
Phenylephrine HCl 5 mg
Pain reliever/fever reducer
Expectorant
Nasal decongestant
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
if a skin reaction occurs, stop use and seek medical help right away.
taking the blood thinning drug warfarin.
do not exceed recommended dosage.
These could be signs of a serious condition.
ask a health professional before use.
In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
corn starch, crospovidone, flavor, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silica gel, silicon dioxide, sodium starch glycolate, stearic acid, sucralose, talc, titanium dioxide
1-800-426-9391
CVS Health™
Compare to the active ingredients in Tylenol® SINUS SEVERE*
Daytime
NDC 59779-275-08
Non-Drowsy
Severe Sinus Pain
& Congestion
ACETAMINOPHEN - Pain reliever, Fever reducer
GUAIFENESIN - Expectorant
PHENYLEPHRINE HCl - Nasal decongestant
Relieves:
Sinus headache, Sinus pressure, Chest
congestion, Nasal congestion & Mucus
24 CAPLETS Actual Size
TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING
*This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Tylenol® SINUS SEVERE.
50844 REV0316A52708
Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
© 2016 CVS/pharmacy
CVS.com® 1-800-SHOP CVS
Made in the U.S.A. with domestic and imported ingredients
V-19849
CVS® Quality
Money Back Guarantee
* Please review the disclaimer below.