COLD and FLUDAYTIME MAXIMUM STRENGTH NON-DROWSY SEVERE

Generic name: ACETAMINOPHEN, GUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE, and PHENYLEPHRINE HYDROCHLORIDE

Spirit Pharmaceuticals LLC

Dosage Form

N/A

Manufacturer

Spirit Pharmaceuticals LLC

Active ingredients

ACETAMINOPHEN325 mg
GUAIFENESIN200 mg
DEXTROMETHORPHAN HYDROBROMIDE10 mg
PHENYLEPHRINE HYDROCHLORIDE5 mg

Important Safety Information

This medication contains important usage instructions, warnings, and side effect information that you should review before use.

Full label on DailyMed PDF Full label (ZIP)

temporarily relieves common cold/flu symptoms:
nasal congestion
sinus congestion & pressure
cough due to minor throat & bronchial irritation
minor aches & pains
headache
fever
sore throat
reduces swelling of nasal passages
temporarily restores freer breathing through the nose
promotes nasal and/or sinus drainage
helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive.

When using this product, do not use more than directed.

What it looks like

Photos of the product and/or packaging supplied by the manufacturer.

Package codes (NDC)

68210-4084-1

Full prescribing information (for healthcare professionals)

SPL UNCLASSIFIED SECTION

Drug Facts

Liver warning

This product contains acetaminophen. Severe liver damage may occur if you take

more than 4 doses in 24 hours, which is the maximum daily amount for this product
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.

Overdose warning

Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Sign up for full access

Create a free account to view complete drug information, save medications, and more.

Full drug information and details

Save medications to your personal list

Track your medication history

Get personalized drug safety alerts

Create Free Account Sign In

Free forever · No credit card required

adults & children 12 years & over	2 softgels with water every 4 hours
children 4 to under 12 years	ask a doctor
children under 4 years	do not use

Active ingredients

Important Safety Information

What this medicine is forThe uses this medicine is approved for.

What this medicine is forOver-the-counter use.

How to take itDosage and administration instructions.take only as directed - see Overdose warning do not exceed 4 doses per 24 hours adults & children 12 years & over 2 softgels with water every 4 hours children 4 to under 12 years ask a doctor children under 4 years do no…

Do not use if…Keep out of reach of children.

Ask a doctor before use if…you get nervous, dizzy or sleepless pain, nasal congestion, or cough gets worse or lasts more than 7 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur cough comes back or o…

Ask a doctor or pharmacist before use if…Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin.

Stop use and talk to a doctor if…with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen ask a doctor or pharmacist. if you are now taking a prescription monoamine oxidase…

Storage and handlingstore at room temperature

Package labelCompare to Vicks® DayQuil® Severe Cold&Flue active ingredients†† DAYTIMENON-DROWSY Severe Cold & Flu ACETAMINOPHEN/ACHES/ FEVER/ SORE THROAT DEXTROMETHORPHAN HBr/ COUGH SUPPRESSANT GUAIFENESIN/ EXPECTORANT PHENYLEPHRINE…