FDA.reportPublic FDA data

Nighttime Cough-Kids

Manufacturer
Genexa
Effective date
2025-08-01
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:15:32

Label at a glance#

ProductNighttime Cough-Kids
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, CHLORPHENIRAMINE MALEATE
Label structure11 sections

Storage and handling

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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredients (in each 10 mL)

Chlorpheniramine maleate, USP 2 mg

Dextromethorphan HBr, USP 15 mg

OTC - PURPOSE SECTION

Purposes

Antihistamine

Cough suppressant

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. 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 USING

• 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 older

20 mL every

6 hours

Children 6 to under 12

years

10 mL every

6 hours

Children under 6 years

do not use

STORAGE AND HANDLING SECTION

Other information

store between 20-25°C (68-77°F)

INACTIVE INGREDIENT SECTION

Inactive ingredients

organic agave syrup, organic blueberry flavor, natural flavors, 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 or seal under the cap is disturbed or missing.

Patent Pending | Distributed by: Genexa Inc.

Atlanta, GA 30324 | genexa.com

Made in the USA with globally sourced ingredients

NDC 69676-0088-9

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Genexa®

MEDICINE MADE CLEAN

Ages 6+

Long Acting

Kids' Nighttime Cough

Chlorpheniramine Maleate - Antihistamine

Dextromethorphan HBr- Cough Suppressant

Relieves Cough up to 8 Hours

Runny Nose

Sneezing

Same active ingredients as leading brands

0% Artificial Additives

Always free of common allergens, artificial preservatives, flavors, & dyes

Organic Blueberry Flavor

4 fl oz (118 mL)

10063-GNX_Carton R-2024121710063-GNX_Carton R-20241217

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1111440chlorpheniramine maleate 1 MG / dextromethorphan HBr 7.5 MG in 5 mL Oral SolutionPSN4
1111440chlorpheniramine maleate 0.2 MG/ML / dextromethorphan hydrobromide 1.5 MG/ML Oral SolutionSCD4
1111440chlorpheniramine maleate 1 MG / dextromethorphan hydrobromide 7.5 MG per 5 ML Oral SolutionSY4
1111440chlorpheniramine maleate 2 MG / dextromethorphan hydrobromide 15 MG per 10 ML Oral SolutionSY4

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
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
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69676-0088-9Nighttime Cough-Kids118 mL in 1 BOTTLESOLUTION1184
69676-0088-9Nighttime Cough-Kids1 in 1 CARTONSOLUTION14

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
69676-008869676-0088-9

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
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
AGAVE TEQUILANA STEMJ026JA743YIACT
WATER059QF0KO0RIACT
CHLORPHENIRAMINE MALEATEV1Q0O9OJ9ZACTIB
BLUEBERRY253RUG1X1AIACT

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
Nighttime Cough-KidsCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRGenexa024bb864-4214-1d8b-e063-6394a90aa5732025-08-01WarningsExact identifier
ndc (package): 69676-0088-9
ndc (product): 69676-0088
ndc11 (package): 69676008809
spl id: 3b51473d-2583-c018-e063-6294a90ad65e
spl set id: 024bb864-4214-1d8b-e063-6394a90aa573

Reported adverse events (FAERS/openFDA)#

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