FDA.reportPublic FDA data

Childrens Nighttime Cold and Cough

Manufacturer
KinderFarms, LLC
Effective date
2024-04-10
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:10:56

Label at a glance#

ProductChildrens Nighttime Cold and Cough
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 irritation as may occur with a cold

Dosage and administration

do not give more than 6 doses in any 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= milliliter shake well before using  age  dose children 6 to under12 years of age 10 mL every 4 hours  children 4 to under 6  years of age do not use unless directed by a doctor  children under 4 years of age do not use

Storage and handling

store between  20-25º (68-77ºF) do not refrigerate protect from light

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 irritation 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 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 chld 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 sedatives 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

SPL UNCLASSIFIED SECTION

  • nervousness, dizziness or sleeplessness occur
  • symptoms do not improve within 7 days or occur with a fever
  • cough persists for more than 7 days, comes back or occurs with a 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 any 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= milliliter
  • shake well before using
 age dose
children 6 to under12 years of age
10 mL every 4 hours
 children 4 to under 6  years of age
do not use unless directed by a doctor
 children under 4 years of age
do not use

Other information

STORAGE AND HANDLING SECTION

  • store between  20-25º (68-77ºF)
  • do not refrigerate
  • protect from light

Inactive ingredients

INACTIVE INGREDIENT SECTION

Organic agave syrup, non-GMO citric acid, organic natural flavors, purified water

QUESTIONS?

OTC - QUESTIONS SECTION

 Call 424-235-0355

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

KIDS NIGHTTIME COLD & COUGH Age 6-11 yrs

Diphenhydramine HCl 6.25 mg per 5 mL

Antihistamine/ Cough Suppressant

Phenylephrine HCl 2.5 mg per 5 mL

Nasal Decongestant

Organic Cherry Flavor

NO COMMON ALLERGENS.

NO DYES OR PARABENS.

DOSING CUP INCLUDED

FL OZ (mL)

TAMPER EVIDENT:  BOTTLE IS SAFETY SEALED. SEALED WITH A PERFORATED BAND AROUND BOTTLE. DO NOT USE IF BOTTLE SEAL IS DISTURBED OR MISSING.

Keep outer carton for complete warnings and product information.

DISTRIBUTED BY: KinderFarms®

Redondo Beach, CA 90277 USA

kinderfarms.com

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

KINDERMED Kids Nighttime Cold & Cough Cherry Flavor
KINDERMED Kids Nighttime Cold & Cough Cherry 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 SolutionPSN3
1236048diphenhydramine hydrochloride 1.25 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral SolutionSCD3
1236048diphenhydramine HCl 12.5 MG / phenylephrine HCl 5 MG per 10 ML Oral SolutionSY3
1236048diphenhydramine HCl 6.25 MG / phenylephrine HCl 2.5 MG per 5 ML Oral SolutionSY3

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
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82673-103-04Childrens Nighttime Cold and Cough1 in 1 BOXLIQUID13
82673-103-04Childrens Nighttime Cold and Cough118 mL in 1 BOTTLELIQUID1183

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82673-103CHILDRENS NIGHTTIME COLD AND COUGH (DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) LIQUID [KINDERFARMS, LLC]3Legacy NDC, 2 package rows20240411_40904eb3-723c-4ddc-8a0e-5ae5ef74c259.zip

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82673-10382673-103-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIB
AGAVE TEQUILANA JUICEGVG8G0207OIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
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
Childrens Nighttime Cold and CoughDIPHENHYDRAMINE HCL, PHENYLEPHRINE HCLKinderFarms, LLC40904eb3-723c-4ddc-8a0e-5ae5ef74c2592024-04-10WarningsExact identifier
ndc (package): 82673-103-04
ndc (product): 82673-103
ndc11 (package): 82673010304
spl id: 0e313a2c-47dd-4188-8e2d-ed0faabe28e1
spl set id: 40904eb3-723c-4ddc-8a0e-5ae5ef74c259

Reported adverse events (FAERS/openFDA)#

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