MULTI-SYMPTOM NITETIME

Generic name: ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, and DOXYLAMINE SUCCINATE

CAPSULES · SPIRIT PHARMACEUTICALS LLC

Dosage Form

CAPSULES

Manufacturer

SPIRIT PHARMACEUTICALS LLC

Active ingredients

ACETAMINOPHEN325 mg
DEXTROMETHORPHAN HYDROBROMIDE15 mg
DOXYLAMINE SUCCINATE6.25 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:

cough due to minor throat and bronchial irritation
sore throat
headache
minor aches/pains
fever
runny nose and sneezing

When using this product

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)

68210-1050-0
68210-1050-1
68210-1050-2

Full prescribing information (for healthcare professionals)

SPL UNCLASSIFIED SECTION

Drug Facts

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

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.

SPL UNCLASSIFIED SECTION

Sore throat warning: If sore throat is severe, lasts for more than 2 days, or occurs with or is followed by fever, headache, rash, nausea, or vomiting, see a doctor promptly.

Overdose warning

Overdose warning: Taking more than the recommended dose 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.

SPL UNCLASSIFIED SECTION

Distributed By:

Spirit Pharmaceuticals, LLC

Ronkonkoma, NY 11779

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 and children 12 years of age and over	swallow 2 softgels with water every 6 hours
children 4 to under 12 years of age	ask a doctor
children under 4 years of age	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 recommended—see Overdose warning. do not exceed 4 doses per 24 hours adults and children 12 years of age and over swallow 2 softgels with water every 6 hours children 4 to under 12 years of age ask a doctor…

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

Ask a doctor before use if…Stop use and ask a doctor if pain 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 occurs with rash, or headac…

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

Stop use and talk to a doctor if…Do not use 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 monoa…

Storage and handlingstore at room temperature 15°-30°C (59°-86°F) and avoid excessive heat this product does not contain phenylpropanolamine

Package labelVALUMEDS™ SEE NEW WARNINGS INFORMATION Compare to the active ingredients in VICKS® NyQUIL®* MULTI-SYMPTOM NITE TIME COLD&FLU NIGHTTIME RELIEF ACETAMINOPHEN, DEXTROMETHORPHAN HBr, DOXYLAMINE SUCCINATE Pain Reliever Fever…

What it looks like

Package codes (NDC)

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

Overdose warning

SPL UNCLASSIFIED SECTION

Sign up for full access