Cold and Flu Severe Nighttime

Generic name: Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, and Phenylephrine Hydrochloride

TOPCO ASSOCIATES LLC

Dosage Form

N/A

Manufacturer

TOPCO ASSOCIATES LLC

Active ingredients

Acetaminophen325 mg
Dextromethorphan Hydrobromide10 mg
Doxylamine Succinate6.5 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
cough to help you sleep
minor aches & pains
headache
fever
sore throat
runny nose & sneezing
reduces swelling of nasal passages
temporarily restores freer breathing through the nose
promotes nasal and/or sinus drainage

do not use more than directed
excitability may occur, especially in children
marked drowsiness may occur
avoid alcoholic drinks
be careful when driving a motor vehicle or operating machinery
alcohol, sedatives, and tranquilizers may increase drowsiness

What it looks like

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

Package codes (NDC)

36800-848-24

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 8 softgels 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

In case of overdose, get medical help or contact a Poison Control Center right away.

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 yrs & over	2 softgels with water every 4 hrs
children 4 to under 12 yrs	ask a doctor
children under 4 yrs	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 do not exceed 8 softgels per 24 hours adults & children 12 yrs & over 2 softgels with water every 4 hrs children 4 to under 12 yrs ask a doctor children under 4 yrs do not use

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…taking sedatives or tranquilizers 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 oxidas…

Storage and handlingstore at 20-25°C (68-77°F) protect from light, heat and moisture

Package labelNDC: 36800-827-24 *Compare to the active ingredientsin Vicks® Nyquil™ Severe Cold & Flu MAXIMUM STRENGTH RELIEFNight TimeCold & Flu ReliefSEVERE PAIN RELIEVER-FEVER REDUCER - ACETAMINOPHENCOUGH SUPPRESSANT - DEXTROMETHOR…