Active Ingredients (In Each Caplet)
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 Walgreen Company for the product Cold And Flu (NDC 0363-0640). 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
Dextromethorphan HBr 10 mg
Guaifenesin 200 mg
Phenylephrine HCl 5 mg
Pain reliever/fever reducer
Cough suppressant
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.
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.
taking the blood thinning drug warfarin.
do not exceed recommended dosage.
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, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polysorbate 80, polyvinyl alcohol, povidone, silicon dioxide, sodium starch glycolate, stearic acid, talc, titanium dioxide
1-800-426-9391
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Compare to Vicks® DayQuil® Severe
Cold & Flu active ingredients††
NDC 0363-0640-08
DAYTIME • NON-DROWSY
Severe
Cold & Flu
ACETAMINOPHEN 325 mg / PAIN RELIEVER / FEVER REDUCER
DEXTROMETHORPHAN HBr 10 mg / COUGH SUPPRESSANT
GUAIFENESIN 200 mg / EXPECTORANT
PHENYLEPHRINE HCI 5 mg / NASAL DECONGESTANT
MAXIMUM STRENGTH
• Relieves headache, fever, sore throat,
minor aches & pains, cough, chest congestion,
nasal/sinus congestion & sinus pressure
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
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††This product is not manufactured
or distributed by The Procter &
Gamble Company, owner of the
registered trademark Vicks®
DayQuil® Severe Cold & Flu.
50844 REV0519C64008
DISTRIBUTED BY: WALGREEN CO.
200 WILMOT RD, DEERFIELD, IL 60015
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