Leader Nighttime Severe Cold and Flu

Manufacturer
Cardinal Health
Effective date
2019-01-03
Label type
HUMAN OTC DRUG LABEL
Version
32
Source
legacy-cache
Hydrated at
2026-08-02 00:35:03

Label at a glance#

ProductLeader Nighttime Severe Cold and Flu
Active ingredientACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE
Label structure8 sections

Indications and uses

temporarily relieves common cold/flu symptoms: • nasal congestion • sinus congestion and pressure • minor aches and pains • headache • fever • sore throat • runny nose and sneezing • cough due to minor throat and bronchial irritation • cough to help you sleep • reduces swelling of nasal passages • promotes nasal and/or sinus drainage • temporarily restores freer breathing through the nose

Dosage and administration

• take only as directed – see Overdose warning • only use the dose cup provided • do not exceed 4 doses per 24 hrs adults & children 12 yrs & over 30 mL every 4 hrs children 4 to under 12 yrs ask a doctor children under 4 yrs do not use • each 30 mL contains: sodium 12 mg • store at 20°-25°C (68°-77°F)

Label contents#

Full prescribing information#

Active ingredients (in each 30 mL)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 650 mg

Dextromethorphan HBr 20 mg

Doxylamine succinate 12.5 mg

Phenylephrine HCl 10 mg

Purpose

OTC - PURPOSE SECTION

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Nasal decongestant

Uses

INDICATIONS & USAGE SECTION

temporarily relieves common cold/flu symptoms:

  • nasal congestion
  • sinus congestion and pressure
  • minor aches and pains
  • headache
  • fever
  • sore throat
  • runny nose and sneezing
  • cough due to minor throat and bronchial irritation
  • cough to help you sleep
  • reduces swelling of nasal passages
  • promotes nasal and/or sinus drainage
  • temporarily restores freer breathing through the nose

Warnings

WARNINGS SECTION

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

  • more than 4,000 mg of acetaminophen in 24 hours
  • 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.

Do not use

OTC - DO NOT USE SECTION

  • 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 inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
  • if you have ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • liver disease
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • glaucoma
  • cough that occurs with too much phlegm (mucus)
  • a breathing problem such as emphysema or chronic bronchitis
  • trouble urinating due to an enlarged prostate gland
  • persistent or chronic cough such as occurs with smoking, asthma, or emphysema

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

  • taking sedatives or tranquilizers
  • taking the blood thinning drug warfarin

When using this product

OTC - WHEN USING SECTION

  • 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

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • 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 occurs with rash or headache that lasts. These could be signs of a serious condition.

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

DOSAGE & ADMINISTRATION SECTION

  • take only as directed – see Overdose warning
  • only use the dose cup provided
  • do not exceed 4 doses per 24 hrs

adults & children 12 yrs & over

30 mL every 4 hrs

children 4 to under 12 yrs

ask a doctor

children under 4 yrs

do not use

Other information

STORAGE AND HANDLING SECTION

  • each 30 mL contains: sodium 12 mg
  • store at 20°-25°C (68°-77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

butylated hydroxyanisole, edetate disodium, FD&C blue #1, FD&C red #40, flavor, glycerin, monobasic sodium phosphate, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sucrose, xanthan gum

Questions or comments?

OTC - QUESTIONS SECTION

1-800-719-9260

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Maximum Strength

Nighttime Severe Cold & Flu

Acetaminophen | Dextromethorphan HBr

Doxylamine Succinate | Phenylephrine HCl

Pain Reliever / Fever Reducer

Cough Suppressant | Antihistamine

Nasal Decongestant

Mixed Berry Flavor

Relief of:

Aches, Fever, Cough

Sore Throat

Nasal/Sinus Congestion

Sneezing, Runny Nose

Alcohol-Free

SEE NEW WARNINGS

COMPARE TO VICKS® NYQUIL® SEVERE

active ingredients

8 FL OZ (237 mL)

Leader Nighttime Severe Cold & Flu image
Leader Nighttime Severe Cold & Flu image

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0194-1ML - Milliliter70000-0194705a8c5a-723f-4981-9783-be12f77f5a4c12017-11-06

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70000-019470000-0194-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ebb8ea3b-6f72-4914-9876-0543d232056f8fee5c68-e6d6-4811-a49a-0c8d50772ebd2019-11-20WarningsExact identifier
spl set id: 8fee5c68-e6d6-4811-a49a-0c8d50772ebd

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.