FDA.reportPublic FDA data

Daytime Cough Congestion Nighttime Cold Cough

Manufacturer
KinderFarms, LLC
Effective date
2024-09-12
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:19:28

Label at a glance#

ProductDaytime Cough Congestion Nighttime Cold Cough
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, DIPHENHYDRAMINE HYDROCHLORIDE
Label structure12 sections

Indications and uses

Daytime helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive temporarily relieves cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants the intensity of coughing the impulse to cough to help your child get to sleep Nighttime temporarily relieves: sneezing runny nose itching ...

Dosage and administration

Daytime do not take more than 6 doses in any 24-hour period 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 under 12 years  5-10 mL every 4 hours  children 4 to under 6 years 2.5-5 mL every 4 hours  children under 4 years do not use Nighttime adults and children 6 years and over: do not exceed mo...

Storage and handling

Daytime store between 20-25ºC (68º-77ºF). Do not refrigerate. Nighttime store between 20-25ºC (68-77ºF). Do not refrigerate protect from light

Label contents#

Full prescribing information#

Active ingredient Daytime (in each 5 mL)

OTC - ACTIVE INGREDIENT SECTION

Dextromethorphan HBr USP, 5 mg

Guaifenesin USP, 100 mg

Active ingredient Nighttime (in each 5 mL)

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine HCl 12.5 mg

Purposes for Day Time

OTC - PURPOSE SECTION

Cough suppressant

Expectorant

Purposes for Night Time

OTC - PURPOSE SECTION

Antihistamine/Cough suppressant

Uses

INDICATIONS & USAGE SECTION

Daytime

  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
  • temporarily relieves
    • cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
    • the intensity of coughing
    • the impulse to cough to help your child get to sleep

Nighttime

  • temporarily relieves:
    • sneezing
    • runny nose
    • itching of the 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 cold or inhaled irritants
    • the intensity of coughing

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

DAYTIME

in a child who is taking a prescription monoamine oxidase inhibitor (MAOI) (certan 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 childs prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.

NIGHTTIME

  • in a child under 4 years of age
  • with any other product containing diphenhydramine even one used on the skin
  • for the purpose of making your child sleepy

Ask a doctor before use your child has

OTC - ASK DOCTOR SECTION

DAYTIME

  • cough that occurs with too much phlegm (mucus)
  • persistent or chronic cough such occurs with asthma

NIGHTTIME

  • glaucoma
  • cough that occurs with too much phlegm (mucus)
  • persistent or chronic cough such as occur with smoking, asthma, or emphysema
  • 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

NIGHTTIME

taking sedatives or tranquilizers.

When using this product

OTC - WHEN USING SECTION

Nighttime

  • do not exceed recommended dosage
  • marked drowsiness may occur
  • excitability may occur, especially in children
  • alcohol, sedatives and tranquilizers may increase the drowsiness effect
  • avoid alcoholic beverages
  • use caution when driving a motor vehicle or operating machinery

Stop use and ask a doctor if

OTC - STOP USE SECTION

DAYTIME

cough lasts more than 7 days, comes back, or occurs with a fever, rash, or headache that lasts.These could be signs of a serious condition.

NIGHTTIME

cough persists for more than 1 weeks, tend 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 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

Daytime

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. 

Nighttime

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Daytime

  • do not take more than 6 doses in any 24-hour period
  • measure only with dosing cup provided. Do not use any other dosing device.
  • keep dosing cup with product
  • mL = milliliter
  • shake well before using
agedose
 children 6 to under 12 years 5-10 mL every 4 hours
 children 4 to under 6 years2.5-5 mL every 4 hours
 children under 4 yearsdo not use


Nighttime

  • adults and children 6 years and over: do not exceed more than 6 doses in 24 hour 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

Daytime

  • store between 20-25ºC (68º-77ºF).
  • Do not refrigerate.

Nighttime

  • store between 20-25ºC (68-77ºF).
  • Do not refrigerate
  • protect from light

Inactive ingredients

INACTIVE INGREDIENT SECTION

Day Time

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

Night Time

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

Questions or comments?

OTC - QUESTIONS SECTION

Call 424-235-0355

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Same active ingredients as Mucinex Children's® Cough†

KIDS' COUGH & CONGESTION  Ages 4-11 yrs

Dextromethorphan HBr 5 mg per 5 mL

Cough Suppressant

Guaifenesin 100 mg per 5 mL

Expectorant

Organic Berry Flavor

DOSING CUP INCLUDED

FL OZ (mL)

keep outer carton for complete warnings and product information

KIDS'  Ages 6+

NIGHTTIME

COLD & COUGH

Diphenhydramine HCl 12.5 mg per 5 mL

Antihistamine/Cough Suppressant

Organic Cherry Flavor

DOSING CUP INCLUDED

fl oz (mL)

DO NOT TAKE KIDS' COUGH & CONGESTION AND KIDS' NIGHTTIME COLD & COUGH AT THE SAME TIME.

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

.†THIS PRODUCT IS NOT MANUFACTURED OR DISTRIBUTED BY RB HEALTH (US) LLC, DISTRIBUTOR OF MUCINEX CHILDREN'S® COUGH

DISTRIBUTED BY: KinderFarm®

Redondo Beach, CA 90277

 

Product Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

KINDERMED Kids Cough & Congestion Kids Nighttime Cold & Cough
KINDERMED Kids Cough & Congestion Kids Nighttime Cold & Cough

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2683226{1 (dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML Oral Solution) / 1 (diphenhydramine hydrochloride 2.5 MG/ML Oral Solution) } PackGPCK3
26832261 daytime (dextromethorphan HBr 5 MG / guaiFENesin 100 MG in 5 mL Oral Solution) / 1 nighttime (diphenhydrAMINE hydrochloride 12.5 MG in 5 mL Oral Solution) PackPSN3
1020138dextromethorphan HBr 20 MG / guaiFENesin 400 MG in 20 mL Oral SolutionPSN3
1049906diphenhydrAMINE HCl 12.5 MG in 5 mL Oral SolutionPSN3
1020138dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML Oral SolutionSCD3
1049906diphenhydramine hydrochloride 2.5 MG/ML Oral SolutionSCD3
26832261 daytime (dextromethorphan HBr 5 MG / guaifenesin 100 MG per 5 ML Oral Solution) / 1 nighttime (diphenhydramine hydrochloride 12.5 MG per 5 ML Oral Solution) PackSY3
1020138dextromethorphan HBr 20 MG / guaifenesin 400 MG per 20 ML Oral SolutionSY3
1020138dextromethorphan HBr 5 MG / guaifenesin 100 MG per 5 ML Oral SolutionSY3
1049906diphenhydramine HCl 12.5 MG per 5 ML Oral SolutionSY3
1049906diphenhydramine hydrochloride 25 MG per 10 ML Oral SolutionSY3
1049906diphenhydramine hydrochloride 50 MG per 20 ML Oral SolutionSY3

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DEXTROMETHORPHAN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
DIPHENHYDRAMINE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813
GUAIFENESIN Pharmacologic Class Indexing1Indexing - Pharmacologic Class20211129

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
82673-102-04Daytime Cough Congestion Nighttime Cold Cough1 in 1 BOXLIQUID100 mg in 5mL3
82673-102-04Daytime Cough Congestion Nighttime Cold Cough118 mL in 1 BOTTLE, PLASTICLIQUID118 mL5 mg in 5mL3
82673-191-04Daytime Cough Congestion Nighttime Cold Cough118 mL in 1 BOTTLE, PLASTICLIQUID118 mL12.5 mg in 5mL3
82673-191-04Daytime Cough Congestion Nighttime Cold Cough1 in 1 BOXLIQUID12.5 mg in 5mL3
82673-901-08Daytime Cough Congestion Nighttime Cold Cough1 in 1 KITKIT13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82673-102DAYTIME COUGH CONGESTION NIGHTTIME COLD COUGH (DEXTROMETHORPHAN HBR, GUAIFENESIN, DIPHENHYDRAMINE HCL) KIT [KINDERFARMS, LLC]3Current NDC, Legacy NDC20240913_f2113abf-c1a3-42a6-a25e-e30a31fcad95.zip
82673-191DAYTIME COUGH CONGESTION NIGHTTIME COLD COUGH (DEXTROMETHORPHAN HBR, GUAIFENESIN, DIPHENHYDRAMINE HCL) KIT [KINDERFARMS, LLC]3Current NDC20240913_f2113abf-c1a3-42a6-a25e-e30a31fcad95.zip
82673-901DAYTIME COUGH CONGESTION NIGHTTIME COLD COUGH (DEXTROMETHORPHAN HBR, GUAIFENESIN, DIPHENHYDRAMINE HCL) KIT [KINDERFARMS, LLC]35 package rows20240913_f2113abf-c1a3-42a6-a25e-e30a31fcad95.zip

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82673-90182673-901-08
82673-10282673-102-04
82673-19182673-191-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
GUAIFENESIN495W7451VQACTIB
AGAVE TEQUILANA JUICEGVG8G0207OIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB
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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mucus Relief Cough and Congestion ChildrensDEXTROMETHORPHAN HBR, GUAIFENESINKinderFarms, LLC5b123501-cc51-42cd-b7b7-65833f44166b2024-10-04WarningsExact identifier
ndc (package): 82673-102-04
ndc (product): 82673-102
ndc11 (package): 82673010204
Nighttime Cold and CoughDIPHENHYDRAMINE HCLKinderFarms, LLCbfcedca7-f758-4654-822a-5c431906f34d2024-10-01WarningsExact identifier
ndc (package): 82673-191-04
ndc (product): 82673-191
ndc11 (package): 82673019104
Daytime Cough Congestion Nighttime Cold CoughDEXTROMETHORPHAN HBR, GUAIFENESIN, DIPHENHYDRAMINE HCLKinderFarms, LLCf2113abf-c1a3-42a6-a25e-e30a31fcad952024-09-12WarningsExact identifier
ndc (package): 82673-191-04
ndc (package): 82673-102-04
ndc (package): 82673-901-08
ndc (product): 82673-901
ndc11 (package): 82673010204
ndc11 (package): 82673019104
ndc11 (package): 82673090108
spl id: f567bdb0-60ac-4ab1-b1ec-f20b8726a3a1
spl set id: f2113abf-c1a3-42a6-a25e-e30a31fcad95

Reported adverse events (FAERS/openFDA)#

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