FDA.reportPublic FDA data

Night Time Cough

Manufacturer
Safeway, Inc.
Effective date
2024-05-15
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:12:34

Label at a glance#

ProductNight Time Cough
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE
Label structure10 sections

Indications and uses

temporarily relieves cold symptoms cough due to minor throat and bronchial irritation runny nose and sneezing

Dosage and administration

do not take more than 4 doses in any 24-hours period measure only with dosing cup provided. Do not use any other dosing device keep dosing cup with product take only as directed mL = milliliter adults and children 12 years and over: 30 mL every 6 hours children under 12 years of age: do not use

Storage and handling

each 30 mL contains ; sodium 29 mg store between 20-25ºC (68-77ºF). Do not refrigerate.

Label contents#

Full prescribing information#

Active ingredients (in each 30 mL)

OTC - ACTIVE INGREDIENT SECTION

Dextromethorphan HBr 30 mg

Doxylamine succinate 12.5 mg

Purpose

OTC - PURPOSE SECTION

Cough suppressant

Antihistamine

Uses

INDICATIONS & USAGE SECTION

  • temporarily relieves cold symptoms
  • cough due to minor throat and bronchial irritation
  • runny nose and sneezing

Warnings

WARNINGS SECTION

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.

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

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

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

taking sedatives or tranquilizers.

When using this product

OTC - WHEN USING SECTION

  • 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

cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache.

These could be sign 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 overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • do not take more than 4 doses in any 24-hours period
  • measure only with dosing cup provided. Do not use any other dosing device
  • keep dosing cup with product
  • take only as directed
  • mL = milliliter
  • adults and children 12 years and over: 30 mL every 6 hours
  • children under 12 years of age: do not use

Other information

STORAGE AND HANDLING SECTION

  • each 30 mL contains; sodium 29 mg
  • store between 20-25ºC (68-77ºF). Do not refrigerate.

Inactive ingredients

INACTIVE INGREDIENT SECTION

alcohol, citric acid, FD&C blue 1, FD&C red 40, flavor, high fructose corn syrup, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium citrate

Questions or comments?

OTC - QUESTIONS SECTION

 Call 1-888-723-3929 Monday-Friday 7AM-6PM PST

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Compare to Vicks® NyQuil® Cough active ingredients*

NightTime Cough Relief 

DEXTROMETHORPHAN HBr 30 mg - Cough Suppressant

DOXYLAMINE SUCCINATE 12.5 mg - Antihistamine

CHERRY FLAVOR

  • Sneezing, runny nose, cough
  • For ages 12 years & over
  • Nighttime relief
  • Alcohol 10%

FL OZ (mL)

*This product is not manufactured or distributed by The Proctor & Gamble Company,  Vicks® and NyQuil® are registered trademarks of The Procter & Gamble Company.

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND DOSAGE CUP OR UNDER CAP IS BROKEN OR MISSING.

DISTREBUTED BY BETTER LIVING BRANDS LLC

P.O. BOX 99, PLEASANTON, CA 94566-0009

www.betterlivingbrandsLLC.com

Product Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SIGNATURE CARE Nighttime Cough Relief
SIGNATURE CARE Nighttime Cough Relief

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1234386dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG in 30 mL Oral SolutionPSN4
1234386dextromethorphan hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral SolutionSCD4
1234386dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG per 15 ML Oral SolutionSY4
1234386dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG per 30 ML Oral SolutionSY4

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21130-499-12Night Time Cough355 mL in 1 BOTTLE, PLASTICLIQUID3554

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21130-499NIGHT TIME COUGH (DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [SAFEWAY, INC.]4Current NDC, Legacy NDC, 1 package rows20240516_f658a03b-6fc2-4b63-b3ab-7e886fbf20b4.zip

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
21130-49921130-499-12

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
DOXYLAMINE SUCCINATEV9BI9B5YI2ACTIB
ALCOHOL3K9958V90MIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
FD&C RED NO. 40WZB9127XOAIACT
HIGH FRUCTOSE CORN SYRUPXY6UN3QB6SIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
TRISODIUM CITRATE DIHYDRATEB22547B95KIACT

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
Night Time CoughDEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATESafeway, Inc.f658a03b-6fc2-4b63-b3ab-7e886fbf20b42024-05-15WarningsExact identifier
ndc (package): 21130-499-12
ndc (product): 21130-499
ndc11 (package): 21130049912
spl id: fe3d9fc3-fb69-4c27-9c5f-e356968d046f
spl set id: f658a03b-6fc2-4b63-b3ab-7e886fbf20b4

Reported adverse events (FAERS/openFDA)#

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