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Drug Facts

Manufacturer
KinderFarms, LLC
Effective date
2026-09-28
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
daily-update
Hydrated at
2026-09-30 01:01:58

Label at a glance#

ProductNighttime Cold and Cough
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure10 sections

Indications and uses

temporarily relieves: sneezing runny nose itchy nose or throat itchy, watery eyes due to hay fever or other upper respiratory allergies the impulse to cough cough to help you get to sleep cough due to minor throat and bronchial irritation as may occur with a cold or inhaled irritant the intensity of coughing

Dosage and administration

adults and children 6 years and over: do not exceed 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 shake well before using mL= milliliter Age  Dose adults and children 12 years of age and over  10 mL every 4 hours children 6 to under 12 years of age  5 mL every 4 hours children 4 to under 6 years o...

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 12.5 mg

Purposes

OTC - PURPOSE SECTION

Antihistamine/

Cough suppressant

Uses

INDICATIONS & USAGE SECTION

temporarily relieves:

  • sneezing
  • runny nose
  • itchy nose or throat
  • itchy, watery eyes due to hay fever or other upper respiratory allergies
  • the impulse to cough
  • cough to help you get to sleep
  • cough due to minor throat and bronchial irritation as may occur with a cold or inhaled irritant
  • the intensity of coughing

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

  • in a child under 4 years of age
  • 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

  • glaucoma
  • cough that occurs with too much phlegm (mucus)
  • persistent or chronic cough such as occurs with smoking, asthma, or emphysema
  • diabetes
  • a breathing problem such as emphysema or chronic bronchitis
  • difficulty in urination due to enlargement of the prostate gland

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
  • alcohol, sedatives and tranquilizers may increase drowsiness effect
  • avoid alcoholic beverages
  • use caution when driving a motor vehicle or operating machinery

Stop use and ask a doctor if

SPL UNCLASSIFIED SECTION

  • cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition.

If pregnant or breat-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

  • adults and children 6 years and over: do not exceed 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
  • shake well before using
  • mL= milliliter
Age
 Dose
adults and children 12 years of age and over
 10 mL every 4 hours
children 6 to under 12 years of age
 5 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 flavor, purified water

QUESTIONS?

OTC - QUESTIONS SECTION

Call 424-235-0355

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

KIDS' Ages 6 yrs+.

NIGHTTIME

COLD & COUGH

Diphenhydramine HCl 12.5 mg per 5 mL

Antihistamine/Cough Suppressant

Organic Cherry Flavor

DOSING CUP INCLUDED

FL OZ (mL)

TAMPER EVIDENT: BOTTLE IS SAFETY 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

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

KINDERMED Kids Nighttime Cold & Cough Organic Cherry Flavor
KINDERMED Kids Nighttime Cold & Cough Organic Cherry Flavor

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

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82673-19182673-191-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB
AGAVE TEQUILANA JUICEGVG8G0207OIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
WATER059QF0KO0RIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
52024-10-01full-release2026-06-01 00:22:23

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
0fa2e761-d127-4e6a-9751-988e97fe1101bfcedca7-f758-4654-822a-5c431906f34d2024-10-01WarningsExact identifier
spl set id: bfcedca7-f758-4654-822a-5c431906f34d

Reported adverse events (FAERS/openFDA)#

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