FDA.reportPublic FDA data

Night Time Cold and Flu Relief

Manufacturer
P & L Development, LLC
Effective date
2023-04-19
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 21:32:51

Label at a glance#

ProductNight Time Cold and Flu Relief Multi Symptom
Active ingredientACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE
Label structure10 sections

Indications and uses

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

Dosage and administration

do not take more than directed (see Overdose warning) do not take more than 4 doses in 24 hours adults and children 12 years and over: take 2 softgels with water every 6 hours swallow whole; do not crush, chew, or dissolve children under 12 years: do not use when using other Daytime or Nighttime products, carefully read each label to insure correct dosing

Label contents#

Full prescribing information#

Active ingredients (in each softgel)

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
    • headache
    • minor aches and pains
    • 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 of acetaminophen in 24 hours
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks everyday 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 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 of pharmacist before taking this product.

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

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

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 drinks
  • marked drowsiness may occur
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful 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
  • 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: Taking more than the recommended dose can cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. 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

  • do not take more than directed (see Overdose warning)
  • do not take more than 4 doses in 24 hours
  • adults and children 12 years and over: take 2 softgels with water every 6 hours
  • swallow whole; do not crush, chew, or dissolve
  • children under 12 years: do not use
  • when using other Daytime or Nighttime products, carefully read each label to insure correct dosing

Other information

OTHER SAFETY INFORMATION

  • store between 15-30ºC (59-86ºF)
  • avoid excessive heat

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

nighttime multi-symptom relief

cold & flu

acetaminophen (pain reliever/fever reducer)

dextromethorphan HBr (cough suppressant)

doxylamine succinate (antihistamine) 

  • alcohol-free

softgels**

(**liquid-filled capsules)

†Compare to the active ingredients in Vicks® NyQuil® Cold & Flu LiquiCaps®

†This product is not manufactured or distributed by The Procter & Gamble Company. Vicks®, NyQuil®, and LiquiCaps®  are registered trademark of The Procter & Gamble Company.

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

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

Distributed by: PL Developments

200 Hicks Street, Westbury, NY 11590

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

WELLNESS BASICS Nighttime Cold & Flu Relief
WELLNESS BASICS Nighttime Cold & Flu Relief

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
59726-399-242023-04-19C16284748780-1d6a99b39-369b-a426-e053-dadaa90af4c2Drug Facts
59726-399-482023-04-19C16284748780-1d6a99b39-369b-a426-e053-dadaa90af4c2Drug Facts
59726-399-242022-01-28C16284748780-1d6a99b39-369b-a426-e053-dadaa90af4c2Drug Facts
59726-399-482022-01-28C16284748780-1d6a99b39-369b-a426-e053-dadaa90af4c2Drug Facts

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59726-399NIGHT TIME COLD AND FLU RELIEF MULTI SYMPTOM (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) CAPSULE, LIQUID FILLED [P & L DEVELOPMENT, LLC]2Legacy NDC20230420_e92dbb7d-7f32-4e00-9870-a0df052d8fc5.zip

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
59726-39959726-399-24, 59726-399-48

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
ACETAMINOPHEN362O9ITL9DACTIB
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
DOXYLAMINE SUCCINATEV9BI9B5YI2ACTIB
D&C YELLOW NO. 1035SW5USQ3GIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
GELATIN2G86QN327LIACT
GLYCERINPDC6A3C0OXIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
POVIDONEFZ989GH94EIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SORBITAN6O92ICV9RUIACT
SORBITOL506T60A25RIACT
MANNITOL3OWL53L36AIACT
LECITHIN, SOYBEAN1DI56QDM62IACT
LIGHT MINERAL OILN6K5787QVPIACT

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
9dff28f5-d10b-4876-ab2d-e04677092ed3e92dbb7d-7f32-4e00-9870-a0df052d8fc52023-04-19WarningsExact identifier
spl id: 9dff28f5-d10b-4876-ab2d-e04677092ed3
spl set id: e92dbb7d-7f32-4e00-9870-a0df052d8fc5

Reported adverse events (FAERS/openFDA)#

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