NIGHTTIME COUGH-KIDS- chlorpheniramine maleate, dextromethorphan hbr solution

Nighttime Cough-Kids by

Drug Labeling and Warnings

Nighttime Cough-Kids by is a Otc medication manufactured, distributed, or labeled by Genexa. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients (in each 10 mL)

Chlorpheniramine maleate, USP 2 mg

Dextromethorphan HBr, USP 15 mg

PURPOSE

Purposes

Antihistamine

Cough suppressant

INDICATIONS & USAGE

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

Warnings

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

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

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers

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

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.

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

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

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

• Age: Dose
• 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

Other information

store between 20-25°C (68-77°F)

INACTIVE INGREDIENT

Inactive ingredients

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

QUESTIONS

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

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)

INGREDIENTS AND APPEARANCE

NIGHTTIME COUGH-KIDS 
chlorpheniramine maleate, dextromethorphan hbr solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69676-0088
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	15 mg  in 10 mL
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U)	CHLORPHENIRAMINE MALEATE	2 mg  in 10 mL

Inactive Ingredients
Ingredient Name	Strength
AGAVE TEQUILANA STEM (UNII: J026JA743Y)
WATER (UNII: 059QF0KO0R)
BLUEBERRY (UNII: 253RUG1X1A)

Product Characteristics
Color	brown (Light)	Score
Shape		Size
Flavor	BLUEBERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69676-0088-9	1 in 1 CARTON	05/06/2025
1		118 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	05/06/2025

Labeler - Genexa (079751024)