FDA.reportPublic FDA data

NITETIME COUGH

Manufacturer
KINGSTON PHARMA LLC
Effective date
2019-01-30
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:58:28

Label at a glance#

ProductNITETIME COUGH
Active ingredientACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE
Label structure12 sections

Storage and handling

Other information Store between 15-30 degree Celsius (59-86 degree Fahrenheit) Each tablespoon contains: Sodium 46mg

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient (in each 15 mL = 1 tablespoon):
Acetaminophen 325 mg
Dextromethorphan HBr 15 mg
Doxylamine Succinate 6.25 mg

OTC - PURPOSE SECTION

Purpose:
Pain reliever/fever reducer
Cough suppressant
Antihistamine

INDICATIONS & USAGE SECTION

Uses

  • Temporarily relieves these common cold/flu symptoms
    1. Cough due to minor throat and bronchial irritation
    2. Runny nose and sneezing
    3. Minor aches and pains
    4. Headache
    5. Sore throat
    6. Fever

WARNINGS SECTION

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if adult/child takes

  • More than 4 doses in 24 hours, which is the maximum daily amount for this product.
  • With other drugs containing acetaminophen.
  • Adult has 3 or more alcoholic drinks every day while using this product.

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.

OTC - DO NOT USE SECTION

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 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.
  • To make a child sleep.

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL ON THE BOTTLE IS BROKEN OR MISSING.

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have

  • Glaucoma
  • Liver disease
  • Heart disease
  • High blood pressure
  • Thyroid disease
  • Diabetes
  • Trouble urinating due to an enlarged prostate gland
  • Persistent or chronic cough such as occurs with smoking, asthma or emphysema
  • Cough that occurs with too much phlegm (mucus)
  • A sodium restricted diet

Ask a doctor or pharmacist before use if you are

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

OTC - WHEN USING SECTION

When using this product

  • Do not exceed recommended dosage
  • Excitability may occur especially in children
  • Marked drowsiness may occur
  • Avoid alcoholic drinks
  • Alcohol, sedatives and tranquilizers may increase drowsiness
  • Be careful when driving a motor vehicle or operating machinery

Stop use and ask doctor if

  • Cough lasts more than 7 days, comes back, or occurs with fever, rash, or headache that lasts.

These could be signs of a serious condition

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep this and all drugs out of the reach of children. In case of accidental overdose, seek professional assistance or contact a Poison control center right away.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

DOSAGE & ADMINISTRATION SECTION

Directions:

  • Do not take more than directed.
  • Use enclosed dosing cup.
  • Do not take more than 4 doses in 24-hours.
  • Adults and children 12 years and over: take 2 tablespoons (TBSP) or 30 mL every 6 hours.
  • Children 4 to under 12 years: ask a doctor
  • Children under 4 years: do not use
  • When using other Daytime or Nite time products, carefully read each label to insure correct dosing

STORAGE AND HANDLING SECTION

Other information

  • Store between 15-30 degree Celsius (59-86 degree Fahrenheit)
  • Each tablespoon contains: Sodium 46mg

INACTIVE INGREDIENT SECTION

Inactive ingredients: Alcohol, Anhydrous citric acid, FD&C blue 1, FD&C red 40, flavor, High fructose corn syrup, Polyethylene glycol, Propylene glycol, Saccharin sodium, Sodium citrate and Purified Water.

HOW SUPPLIED SECTION

(packs: 4oz, 6oz, 10oz & 12oz) Kingston NDC# 71027-041-06

Manufactured by: Kingston Pharma LLC
5 County Route 42
Massena, NY 13662

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label
Label
Label 2
Label 2

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1043400acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG in 30 mL Oral SolutionPSN2
1043400acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral SolutionSCD2
1043400acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG per 15 ML Oral SolutionSY2
1043400acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG per 30 ML Oral SolutionSY2
1043400APAP 21.7 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral SolutionSY2

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DEXTROMETHORPHAN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
DOXYLAMINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
f4368033-af8c-41bf-a84b-ff77392b8522Product name120161229

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71027-041-062020-09-27C16284748780-1ab0e2407-3079-f274-e053-dbdaa90a6471NITETIME COUGH
71027-041-062020-09-25C16284748780-1ab0e2407-3079-f274-e053-dbdaa90a6471NITETIME COUGH
71027-041-062020-07-22C16284748780-1ab0e2407-3079-f274-e053-dbdaa90a6471NITETIME COUGH

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71027-041-06NITETIME COUGH177 mL in 1 BOTTLELIQUID1772
71027-041-06NITETIME COUGH1 in 1 CARTONLIQUID12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71027-041NITETIME COUGH LIQUID [KINGSTON PHARMA LLC]2Legacy NDC, 2 package rows20190206_de9c6c1d-ff69-49c2-8c18-2a556d229836.zip

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71027-04171027-041-06

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
ALCOHOL3K9958V90MIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
FD&C RED NO. 40WZB9127XOAIACT
METHYL SALICYLATELAV5U5022YIACT
HIGH FRUCTOSE CORN SYRUPXY6UN3QB6SIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
SACCHARIN SODIUMSB8ZUX40TYIACT
SODIUM CITRATE, UNSPECIFIED FORM1Q73Q2JULRIACT
WATER059QF0KO0RIACT

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
1d0151fa-01e3-4cfa-9e7e-86e31ecfd8c4de9c6c1d-ff69-49c2-8c18-2a556d2298362019-01-30WarningsExact identifier
spl id: 1d0151fa-01e3-4cfa-9e7e-86e31ecfd8c4
spl set id: de9c6c1d-ff69-49c2-8c18-2a556d229836

Reported adverse events (FAERS/openFDA)#

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