FDA.reportPublic FDA data

Kids' Daytime Cough + Nighttime Cough Combo pack

Manufacturer
Genexa Inc.
Effective date
2026-02-25
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:56:15

Label at a glance#

ProductKids Daytime Cough and Nighttime Cough combo pack
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, CHLORPHENIRAMINE MALEATE, GUAIFENESIN
Label structure19 sections

Storage and handling

Other information store between 20-25 º C (68-77 º F)

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Kids' Cough & Chest Congestion - Daytime

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredients

(in each 5 mL)

Dextromethorphan HBr, USP 5 mg

Guaifenesin, USP 100 mg

OTC - PURPOSE SECTION

Purposes

Cough suppressant

Expectorant

INDICATIONS & USAGE SECTION

Uses

  • temporarily relieves cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and makes coughs more productive

WARNINGS SECTION

Warnings

OTC - DO NOT USE SECTION

Do not use 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.

OTC - ASK DOCTOR SECTION

Ask a doctor before use if the child has

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

OTC - STOP USE SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

Directions

  • SHAKE WELL BEFORE EACH USE
  • do not give more than 6 doses in any 24-hour period
  • use only with enclosed dose cup. Do not use with any other dosing device.
  • mL = milliliter
AgeDose
children 6 to under 12 years5 mL - 10 mL every 4 hours
children 4 to under 6 years2.5 mL - 5 mL every 4 hours
children under 4 yearsdo not use

STORAGE AND HANDLING SECTION

Other information

store between 20-25 ºC (68-77 ºF)

INACTIVE INGREDIENT SECTION

Inactive ingredients

agave syrup (organic), blueberry flavor (organic), flavors (natural), purified water

OTC - QUESTIONS SECTION

Questions? 1-855-436-3921

SPL UNCLASSIFIED SECTION

Kids' Long-Acting Nighttime Cough

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredients

(in each 10 mL)

Chlorpheniramine maleate, USP 2 mg

Dextromethorphan HBr, USP 15 mg

INDICATIONS & USAGE SECTION

Uses

  • temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
  • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
  • runny nose
  • sneezing
  • itchy, watery eyes
  • itching of the nose or throat

WARNINGS SECTION

Warnings

OTC - DO NOT USE SECTION

Do not use

  • to sedate a child or make a child sleepy
  • 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.

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have

  • trouble urinating due to an enlarged prostate gland
  • glaucoma
  • a 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

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers

OTC - WHEN USING SECTION

When using this product

  • Do not use more than directed
  • marked drowsiness may occur
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery
  • excitability may occur, especially in children

OTC - STOP USE SECTION

Stop use and ask a doctor if cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

OVERDOSAGE SECTION

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

DOSAGE & ADMINISTRATION SECTION

Directions

  • SHAKE WELL BEFORE EACH USE
  • measure only with dosing cup provided
  • keep dosing cup with product
  • mL = milliliter
  • do not take more than 4 doses in any 24-hour period
AgeDose
Adults and children 12 years and older20 mL every 6 hours
Children 6 to under 12 years10 mL every 6 hours
Children under 6 yearsdo not use

STORAGE AND HANDLING SECTION

Other information

store between 20-25 ºC (68-77 ºF)

INACTIVE INGREDIENT SECTION

Inactive ingredients

agave syrup (organic), blueberry flavor (organic), flavors (natural), purified water

OTC - QUESTIONS SECTION

Questions? 1-855-436-3921

SPL UNCLASSIFIED SECTION

SHAKE WELL BEFORE EACH USE

DO NOT use if perforated band around the bottle is disturbed or missing.

U.S. Patent No. 11,931,413 (Kids' Daytime Cough)

Distributed by: Genexa Inc.

Atlanta, GA 30324 | genexa.com

PARENTS:

Learn about teen medicine abuse

www.StopMedicineAbuse.org

NDC 69676-0110-9

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

COMBO PACK

Genexa ®

CLEAN MEDICINE

Kids DAYTIME Cough & Chest Congestion

Ages 4-11

Dextromethorphan HBr

Cough Suppressant

Guaifenesin

Expectorant

Cough, Mucus, Chest Congestion

Kids NIGHTTIME Long-Acting Cough Relief

Ages 6+

Chlorpheniramine Maleate

Antihistamine

Dextromethorphan HBr

Cough Suppressant

Sneezing & Runny Nose

Up to 8 Hour Cough Relief

0% Artificial Additives, Dyes, Artificial Sweeteners, Common Allergens

Made with Real Agave + Blueberry Flavoring

TWO - 4 FL OZ (118 mL) BOTTLES

TOTAL - 8 FL OZ (236 mL)

10064-GNX carton_R-2025122610064-GNX carton_R-20251226

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2743069{1 (chlorpheniramine maleate 0.2 MG/ML / dextromethorphan hydrobromide 1.5 MG/ML Oral Suspension) / 1 (dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML Oral Suspension) } PackGPCK1
27430691 daytime (dextromethorphan HBr 5 MG / guaiFENesin 100 MG in 5 mL Oral Suspension) / 1 nighttime (chlorpheniramine maleate 2 MG / dextromethorphan HBr 15 MG in 10 mL Oral Suspension) PackPSN1
1111440chlorpheniramine maleate 1 MG / dextromethorphan HBr 7.5 MG in 5 mL Oral SolutionPSN1
2743068chlorpheniramine maleate 2 MG / dextromethorphan hydrobromide 15 MG in 10 mL Oral SuspensionPSN1
2692303dextromethorphan HBr 20 MG / guaiFENesin 400 MG in 20 mL Oral SuspensionPSN1
1111440chlorpheniramine maleate 0.2 MG/ML / dextromethorphan hydrobromide 1.5 MG/ML Oral SolutionSCD1
2743068chlorpheniramine maleate 0.2 MG/ML / dextromethorphan hydrobromide 1.5 MG/ML Oral SuspensionSCD1
2692303dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML Oral SuspensionSCD1
27430691 daytime (dextromethorphan HBr 5 MG / guaifenesin 100 MG per 5 ML Oral Suspension) / 1 nighttime (chlorpheniramine maleate 2 MG / dextromethorphan hydrobromide 15 MG per 10 ML Oral Suspension) PackSY1
1111440chlorpheniramine maleate 1 MG / dextromethorphan hydrobromide 7.5 MG per 5 ML Oral SolutionSY1
2743068chlorpheniramine maleate 2 MG / dextromethorphan HBr 15 MG per 10 ML Oral SuspensionSY1
1111440chlorpheniramine maleate 2 MG / dextromethorphan hydrobromide 15 MG per 10 ML Oral SolutionSY1
2692303dextromethorphan HBr 20 MG / guaifenesin 400 MG per 20 ML Oral SuspensionSY1
2692303dextromethorphan HBr 5 MG / guaifenesin 100 MG per 5 ML Oral SuspensionSY1

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
d17a97fa-387f-690e-d2be-0083ab044a03Product name320170725
0fdb98e2-b951-a1ce-5715-2b187ba500efProduct name420170718
c6fba691-a132-4ede-95c6-f8c6bd696636Product name120150902
c0200ab5-4954-454e-9676-30b741b245bdProduct name120150730
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69676-0110-9Kids Daytime Cough and Nighttime Cough combo pack2 in 1 BOXKIT21
69676-0110-9Kids Daytime Cough and Nighttime Cough combo pack1 in 1 BOTTLE, PLASTICKIT11

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
69676-011069676-0110-9
69676-0088
69676-0037

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
AGAVE TEQUILANA STEMJ026JA743YIACT
BLUEBERRY253RUG1X1AIACT
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
WATER059QF0KO0RIACT
CHLORPHENIRAMINE MALEATEV1Q0O9OJ9ZACTIB
WATER059QF0KO0RIACT
BLUEBERRY253RUG1X1AIACT
GUAIFENESIN495W7451VQACTIB
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
AGAVE TEQUILANA JUICEGVG8G0207OIACT

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
Kids Cough and Chest CongestionDEXTROMETHORPHAN HBR, GUAIFENESINGenexa Inc.a7ab2140-de09-158f-e053-2a95a90a25a02026-05-28WarningsExact identifier
ndc (product): 69676-0037
Kids Daytime Cough and Nighttime Cough combo packDEXTROMETHORPHAN HBR, GUAIFENESIN, CHLORPHENIRAMINE MALEATEGenexa Inc.4bad39f1-86d4-b8a1-e063-6394a90a7a952026-02-25WarningsExact identifier
ndc (package): 69676-0110-9
ndc (product): 69676-0110
ndc11 (package): 69676011009
spl id: 4bad39f1-86d5-b8a1-e063-6394a90a7a95
spl set id: 4bad39f1-86d4-b8a1-e063-6394a90a7a95
Nighttime Cough-KidsCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRGenexa024bb864-4214-1d8b-e063-6394a90aa5732025-08-01WarningsExact identifier
ndc (product): 69676-0088

Reported adverse events (FAERS/openFDA)#

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