FDA.reportPublic FDA data

Cold and Flu

Manufacturer
Cardinal Health 110, LLC. DBA Leader | LNK International, Inc.
Effective date
2022-08-27
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
legacy-cache
Hydrated at
2026-08-01 21:54:50

Label at a glance#

ProductCold and Flu Nighttime Multi-symptom
Active ingredientACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE
Label structure9 sections

Indications and uses

temporarily relieves common cold and flu symptoms: sore throat minor aches and pains headache fever runny nose and sneezing cough due to minor throat and bronchial irritation

Dosage and administration

do not take more than directed  do not take more than 8 capsules per 24 hours adults and children 12 years and over: take 2 capsules with water every 6 hours children under 12 years: ask a doctor

Storage and handling

TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF) protect from heat, humidity and light see end flap for expiration date and lot number

Label contents#

Full prescribing information#

Active ingredients (in each liquid-filled capsule)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 325 mg
Dextromethorphan HBr 15 mg
Doxylamine succinate 6.25 mg

Purpose

OTC - PURPOSE SECTION

Pain reliever/fever reducer
Cough suppressant
Antihistamine 

Uses

INDICATIONS & USAGE SECTION

  • temporarily relieves common cold and flu symptoms:
  • sore throat
  • minor aches and pains
  • headache
  • fever
  • runny nose and sneezing
  • cough due to minor throat and bronchial irritation

Warnings

WARNINGS SECTION

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

  • more than 4,000 mg in 24 hours, which is the maximum daily amount
  • 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

  • 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
  • to make a child sleepy
  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • liver disease
  • glaucoma
  • a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema
  • cough that occurs with too much phlegm (mucus)
  • difficulty in urination due to enlargement of the prostate gland

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

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

When using this product

OTC - WHEN USING SECTION

  • do not exceed recommended dosage
  • excitability may occur, especially in children
  • avoid alcoholic beverages
  • marked drowsiness may occur
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • use caution when driving a motor vehicle or operating machinery 

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • 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
  • persistent cough lasts for more than one week, tends to recur, or is accompanied by fever, rash, or persistent headache

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

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. 

Directions

DOSAGE & ADMINISTRATION SECTION

  • do not take more than directed 
  • do not take more than 8 capsules per 24 hours
  • adults and children 12 years and over: take 2 capsules with water every 6 hours
  • children under 12 years: ask a doctor

Other information

STORAGE AND HANDLING SECTION

  • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • protect from heat, humidity and light
  • see end flap for expiration date and lot number

Inactive ingredients

INACTIVE INGREDIENT SECTION

D&C yellow #10, edible white ink, FD&C blue #1, gelatin, glycerin, lecithin, mineral oil, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol

Questions or comments?

OTC - QUESTIONS SECTION

1-800-426-9391

Principal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LEADER™

NDC 70000-0134-2

Nighttime | Multi-Symptom

Cold & Flu Relief

Acetaminophen ι Pain Reliever / Fever Reducer
Dextromethorphan HBr ι Cough Suppressant
Doxylamine Succinate ι Antihistamine

Relief Of:
Headache, Fever,
Sore throat, Cough,
Sneezing, Runny Nose

24 LIQUID GELS

ACTUAL SIZE

COMPARE TO VICKS®
NYQUIL® COLD & FLU
LIQUICAPS®
active ingredients*

100% Money Back Guarantee

CIN 5283825    REV. 2/17

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER 
UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

CardinalHealth™

DISTRIBUTED BY CARDINAL HEALTH
DUBLIN, OHIO 43017
www.myleader.com 1-800-200-6313
Essential to Care™ since 1979

©2017 Cardinal Health. All rights Reserved.
CARDINAL HEALTH, the Cardinal Health LOGO,
LEADER, and the Leader LOGO are trademarks
or registered trademarks of Cardinal Health.

PARENTS:
Learn about teen medicine abuse
www.StopMedicineAbuse.org

Product of China
Packaged and Quality Assured in the USA

All LEADER™ Brand Products Have A
100% Money Back Guarantee
Return to place of purchase if not satisfied.

*This product is not manufactured or distributed by Procter & Gamble, owner
of the registered trademark Vicks® NyQuil® Cold & Flu LiquiCaps®.

50844   ORG021666008

Leader 44-660
Leader 44-660

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0134-1EA - Each70000-0134414566af-04e7-4dc6-9a52-12d0df736fee12019-01-24
70000-0134-2EA - Each70000-01344423b7aa-674a-4d07-906a-771dc367b39f12017-12-14

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70000-013470000-0134-2, 70000-0134-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
ACETAMINOPHEN362O9ITL9DACTIB
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
DOXYLAMINE SUCCINATEV9BI9B5YI2ACTIB
D&C YELLOW NO. 1035SW5USQ3GIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
GELATIN, UNSPECIFIED2G86QN327LIACT
GLYCERINPDC6A3C0OXIACT
LECITHIN, SOYBEAN1DI56QDM62IACT
MINERAL OILT5L8T28FGPIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
POVIDONE, UNSPECIFIEDFZ989GH94EIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SORBITOL506T60A25RIACT

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
5f5fdfbe-03fb-4594-99e9-bd4fe0ef8eebbcbbb8d1-12f5-4021-a0ed-ebef3bcb5f722023-08-14WarningsExact identifier
spl set id: bcbbb8d1-12f5-4021-a0ed-ebef3bcb5f72

Reported adverse events (FAERS/openFDA)#

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