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 Dolgencorp, Llc for the product Cold And Flu (NDC 55910-573). 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
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Compare to
active ingredients of
Tylenol® COLD + FLU
SEVERE Day & Night*
Severe • Day Time
Cold & Flu
Acetaminophen,
Dextromethorphan HBr,
Guaifenesin, Phenylephrine HCl
Pain Reliever/Fever Reducer, Cough Suppressant,
Expectorant, Nasal Decongestant
16 Caplets
Actual Caplet Size
Severe • Night Time
Cold & Flu
Acetaminophen,
Chlorpheniramine Maleate,
Dextromethorphan HBr, Phenylephrine HCl
Pain Reliever/Fever Reducer, Antihistamine,
Cough Suppressant, Nasal Decongestant
8 Caplets
Actual Caplet 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® COLD + FLU SEVERE Day & Tylenol®
COLD + FLU SEVERE Night.
50844 ORG031650347308
DISTRIBUTED BY
DOLGENCORP, LLC
100 MISSION RIDGE
GOODLETSVILLE, TN 37072
100%
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* Please review the disclaimer below.