Complete SPL Sections#
Active ingredients (in each caplet) (Daytime Cold & Flu Severe)
OTC - ACTIVE INGREDIENT SECTION
Acetaminophen 325 mg Dextromethorphan HBr 10 mg Guaifenesin 200 mg Phenylephrine HCl 5 mg
Purpose
OTC - PURPOSE SECTION
Pain reliever/fever reducer Cough suppressant Expectorant Nasal decongestant
Active ingredients (in each caplet) (Nighttime Cold & Flu Severe)
OTC - ACTIVE INGREDIENT SECTION
Acetaminophen 325 mg Chlorpheniramine maleate 2 mg Dextromethorphan HBr 10 mg Phenylephrine HCl 5 mg
Purpose
OTC - PURPOSE SECTION
Pain reliever/fever reducer Antihistamine Cough suppressant Nasal decongestant
Uses
INDICATIONS & USAGE SECTION
temporarily relieves these common cold and flu symptoms: cough sore throat headache nasal congestion minor aches and pains sinus congestion and pressure sneezing and runny nose (Nighttime only) helps clear nasal passages relieves cough to help you sleep helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive (Daytime only) temporarily reduces fever
Warnings
WARNINGS SECTION
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take more than 4,000 mg of acetaminophen in 24 hours with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include: skin reddening blisters rash If a skin reaction occurs, stop use and seek medical help right away. Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.
Directions
DOSAGE & ADMINISTRATION SECTION
do not take more than directed adults and children 12 years and over take 2 caplets every 4 hours swallow whole – do not crush, chew, or dissolve do not take more than 10 caplets in 24 hours children under 12 years: ask a doctor
Other information
STORAGE AND HANDLING SECTION
each caplet contains: sodium 3 mg TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F) see end flap for expiration date and lot number
Inactive ingredients (Daytime only)
INACTIVE INGREDIENT SECTION
corn starch, crospovidone, D&C yellow #10 aluminum lake, flavor, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, sodium starch glycolate, stearic acid, sucralose, talc, titanium dioxide
Inactive ingredients (Nighttime only)
INACTIVE INGREDIENT SECTION
corn starch, crospovidone, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, flavor, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, sodium starch glycolate, stearic acid, sucralose, talc, titanium dioxide
Questions or comments?
OTC - QUESTIONS SECTION
1-800-426-9391
Principal Display Panel
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
CVS Health® Compare to the active ingredients in Tylenol® COLD + FLU SEVERE Day & Night* Severe Cold & Flu Relief ACETAMINOPHEN - Pain reliever, Fever reducer DEXTROMETHORPHAN HBr - Cough suppressant GUAIFENESIN - Expectorant PHENYLEPHRINE HCl - Nasal decongestant DAYTIME Relieves: Fever, Headache, Sore throat, Nasal congestion, Cough, Mucus, Chest congestion Actual Size 16 CAPLETS ACETAMINOPHEN - Pain reliever, Fever reducer CHLORPHENIRAMINE MALEATE - Antihistamine DEXTROMETHORPHAN HBr - Cough suppressant PHENYLEPHRINE HCl - Nasal decongestant NIGHTTIME Relieves: Fever, Headache, Sore throat, Runny nose, Cough, Nasal congestion Actual Size 8 CAPLETS 24 TOTAL CAPLETS TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING PARENTS: Learn about teen medicine abuse www.StopMedicineAbuse.org Do Not Take Daytime and Nighttime Products at the Same Time. *This product is not manufactured or distributed by KENVUE Inc., owner of the registered trademark Tylenol® COLD + FLU SEVERE Day & Night. 50844 REV0922C50347308 Distributed by: CVS Pharmacy, Inc. One CVS Drive Woonsocket, RI 02895 © 2023 CVS/pharmacy CVS.com® 1-800-SHOP CVS V-19849 100% money back guaranteed. CVS.com/returnpolicy CVS 44-503A473C