FDA.reportPublic FDA data

Childrens Cold and Cough

Manufacturer
Safeway, Inc.
Effective date
2024-05-15
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 00:12:39

Label at a glance#

ProductChildrens Cold and Cough Nighttime
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE
Label structure10 sections

Indications and uses

temporarily relieves sneezing runny nose itchy nose or throat itchy, watery eyes due to hay fever nasal and sinus congestion cough due to minor throat and bronchial irritations as may occur with a cold

Dosage and administration

Do not give more than 6 doses in 24 hours unless directed by a doctor. measure only with dosing cup provided Do not use any other dosing device keep dosing cup with product mL=mililiter shake well before using Age Dose   children 6 to under 12 years  10 mL every 4 hours  children 4 to under 6 years do not use unless directed by a doctor   children under 4 years of age  do not use 

Label contents#

Full prescribing information#

Active ingredients (in each 5 mL)

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine HCl 6.25 mg

Phenylephrine HCl 2.5 mg

Purposes

OTC - PURPOSE SECTION

Antihistamine/Cough suppressant

Nasal decongestant

Uses

INDICATIONS & USAGE SECTION

  • temporarily relieves
    • sneezing
    • runny nose
    • itchy nose or throat
    • itchy, watery eyes due to hay fever
    • nasal and sinus congestion
    • cough due to minor throat and bronchial irritations as may occur with a cold

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

  • in a child under 4 years of age
  • in a child who is 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 child's prescription drug contains an MAOI,  ask a doctor or pharmacist before giving this product.
  • with any other product containing diphenhydramine, even one used on skin
  • for the purpose of making your child sleepy

Ask a doctor before use if the child has

OTC - ASK DOCTOR SECTION

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • glaucoma
  • cough that occurs with too much phlegm (mucus)
  • chronic cough that lasts, or as occurs with asthma
  • a breathing problem such as chronic bronchitis

Ask a doctor or pharmacist before use if the child is

OTC - ASK DOCTOR/PHARMACIST SECTION

 taking sedative or tranquilizers.

When using this product,

OTC - WHEN USING SECTION

  • do not exceed recommended dosage
  • marked drowsiness may occur
  • excitability may occur, especially in children
  • sedatives and tranquilizers may increase drowsiness

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • nervousness, dizziness or sleeplessness occurs
  • symptoms do not improve within 7 days or occur with a fever
  • cough persists for more than 7 days, comes back or occurs with fever, rash or persistent headache.

These could be signs of a serious condition.

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 give more than 6 doses in 24 hours unless directed by a doctor.
  • measure only with dosing cup provided Do not use any other dosing device
  • keep dosing cup with product
  • mL=mililiter
  • shake well before using
AgeDose 
 children 6 to under 12 years 10 mL every 4 hours
 children 4 to under 6 yearsdo not use unless directed by a doctor
 children under 4 years of age  do not use 

Other Information

SPL UNCLASSIFIED SECTION

  • each 5 mL contains: sodium 3 mg
  • store between 20-25ºC (68-77ºF). Do not refrigerate.
  • protect from light

Inactive ingredients

INACTIVE INGREDIENT SECTION

acesulfame potassium, anhydrous citric acid, EDTA disodium, FD&C blue #1, FD&C red #40, flavor, maltitol, propylene glycol, purified water, sodium benzoate, trisodium citrate dihydrate

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 Children's Triaminic® NightTime Cold & Cough active ingredients*

Childrens's Nighttime

Cold & Cough Relief

FOR AGES 6-11 YEARS

Diphenhydramine HCl 6.25 mg - Antihistamine/Cough Suppressant

Phenylephrine HCl 2.5 mg - Nasal Decongestant

GRAPE FLAVOR

  • Relief of: Cough, runny, stuffy nose itchy throat 
  • Alcohol-Free

FL OZ (mL)

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

*This product is not manufactured or distributed by GSK Consumer Healthcare, distributors of Children's Triaminic® Night Time Cold & Cough.

DISTRIBUTED BY

BETTER LIVING BRANDS LLC

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

www.betterlivingbrandsLLC.com

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SIGNATURE CARE Children's Nighttime Cold and Cough Relief Grape Flavor
SIGNATURE CARE Children's Nighttime Cold and Cough Relief Grape Flavor

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1236048diphenhydrAMINE HCl 6.25 MG / phenylephrine HCl 2.5 MG in 5 mL Oral SolutionPSN7
1236048diphenhydramine hydrochloride 1.25 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral SolutionSCD7
1236048diphenhydramine HCl 12.5 MG / phenylephrine HCl 5 MG per 10 ML Oral SolutionSY7
1236048diphenhydramine HCl 6.25 MG / phenylephrine HCl 2.5 MG per 5 ML Oral SolutionSY7

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DIPHENHYDRAMINE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813
PHENYLEPHRINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21130-379-04Childrens Cold and CoughNighttime118 mL in 1 BOTTLE, PLASTICLIQUID1187
21130-379-04Childrens Cold and CoughNighttime1 in 1 BOXLIQUID17

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21130-379CHILDRENS COLD AND COUGH NIGHTTIME (DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) LIQUID [SAFEWAY, INC.]7Current NDC, Legacy NDC, 2 package rows20240517_cbbec807-f882-4c6a-b1cd-c7fd5ce70cad.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
21130-37921130-379-04

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
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIB
ACESULFAME POTASSIUM23OV73Q5G9IACT
SODIUM BENZOATEOJ245FE5EUIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
EDETATE DISODIUM7FLD91C86KIACT
MALTITOLD65DG142WKIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
FD&C RED NO. 40WZB9127XOAIACT
TRISODIUM CITRATE DIHYDRATEB22547B95KIACT
FD&C BLUE NO. 1H3R47K3TBDIACT

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
Childrens Cold and Cough NighttimeDIPHENHYDRAMINE HCL, PHENYLEPHRINE HCLSafeway, Inc.cbbec807-f882-4c6a-b1cd-c7fd5ce70cad2024-05-15WarningsExact identifier
ndc (package): 21130-379-04
ndc (product): 21130-379
ndc11 (package): 21130037904
spl id: 699a52c6-053a-43f9-b7fc-d719aead253d
spl set id: cbbec807-f882-4c6a-b1cd-c7fd5ce70cad

Reported adverse events (FAERS/openFDA)#

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