Active Ingredients (In Each Caplet) (Daytime Cold & Flu Severe)
Acetaminophen 325 mg
Dextromethorphan HBr 10 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 Cold And Flu Relief (NDC 69842-803). 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) (daytime cold & flu severe), purpose, active ingredients (in each caplet) (nighttime cold & flu severe), uses, warnings, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Guaifenesin 200 mg
Phenylephrine HCl 5 mg
Pain reliever/fever reducer
Cough suppressant
Expectorant
Nasal decongestant
Pain reliever/fever reducer
Antihistamine
Cough suppressant
Nasal decongestant
Acetaminophen 325 mg
Chlorpheniramine maleate 2 mg
Dextromethorphan HBr 10 mg
Phenylephrine HCl 5 mg
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.
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.
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.
If taking NIGHTTIME and DAYTIME products, carefully read
each section to ensure correct dosing.
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
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, silica gel, sodium starch glycolate, stearic acid, sucralose, talc, titanium dioxide
1-800-426-9391
CVS® Health™
Compare to the active ingredients in
Tylenol® COLD + FLU SEVERE Day & Night*
DAYTIME - Non-Drowsy
Severe Cold
& Flu Relief
ACETAMINOPHEN - Pain reliever, Fever reducer
DEXTROMETHORPHAN HBr - Cough suppressant
GUAIFENESIN - Expectorant
PHENYLEPHRINE HCI - Nasal decongestant
Relieves:
Fever, Headache, Sore throat,
Nasal congestion, Cough, Mucus,
Chest congestion
16 CAPLETS
NIGHTTIME
Severe Cold
& Flu Relief
ACETAMINOPHEN - Pain reliever, Fever reducer
CHLORPHENIRAMINE MALEATE - Antihistamine
DEXTROMETHORPHAN HBr - Cough suppressant
PHENYLEPHRINE HCI - Nasal decongestant
Relieves:
Fever, Headache, Sore throat,
Runny nose, Cough,
Nasal congestion
8 CAPLETS
Actual Size
24 TOTAL CAPLETS
*This product is not manufactured or distributed by McNeil
Consumer Healthcare, owner of the registered trademark Tylenol®
COLD + FLU SEVERE Day & Night.
TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER
UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING
50844
ORG031650347308
Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
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* Please review the disclaimer below.