KIDS DAYTIME COUGH AND NIGHTTIME COUGH COMBO PACK- dextromethorphan hbr, guaifenesin, chlorpheniramine maleate kit

Drug Labeling and Warnings

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Kids' Cough & Chest Congestion - Daytime

Drug Facts

ACTIVE INGREDIENT

Active ingredients

(in each 5 mL)

Dextromethorphan HBr, USP 5 mg

Guaifenesin, USP 100 mg

PURPOSE

Purposes

Cough suppressant

Expectorant

INDICATIONS & USAGE

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

Warnings

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.

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

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.

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 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

• Age: Dose
• children 6 to under 12 years: 5 mL - 10 mL every 4 hours
• children 4 to under 6 years: 2.5 mL - 5 mL every 4 hours
• children under 4 years: do not use

STORAGE AND HANDLING

Other information

store between 20-25 ºC (68-77 ºF)

INACTIVE INGREDIENT

Inactive ingredients

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

QUESTIONS

Questions? 1-855-436-3921

SPL UNCLASSIFIED SECTION

Kids' Long-Acting Nighttime Cough

Drug Facts

ACTIVE INGREDIENT

Active ingredients

(in each 10 mL)

Chlorpheniramine maleate, USP 2 mg

Dextromethorphan HBr, USP 15 mg

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 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

• 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 ºC (68-77 ºF)

INACTIVE INGREDIENT

Inactive ingredients

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

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)

INGREDIENTS AND APPEARANCE

KIDS DAYTIME COUGH AND NIGHTTIME COUGH COMBO PACK 
dextromethorphan hbr, guaifenesin, chlorpheniramine maleate kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69676-0110

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69676-0110-9	2 in 1 BOX	03/20/2026
1		1 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 BOTTLE	118 mL
Part 2	1 BOTTLE, PLASTIC	118 mL

Part 1 of 2

NIGHTTIME COUGH-KIDS 
chlorpheniramine maleate, dextromethorphan hbr solution

Product Information
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)
BLUEBERRY (UNII: 253RUG1X1A)
WATER (UNII: 059QF0KO0R)

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		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

Part 2 of 2

KIDS COUGH AND CHEST CONGESTION 
dextromethorphan hbr, guaifenesin suspension

Product Information
Item Code (Source)	NDC: 69676-0037
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	100 mg  in 5 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	5 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
BLUEBERRY (UNII: 253RUG1X1A)
AGAVE TEQUILANA JUICE (UNII: GVG8G0207O)

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		118 mL in 1 BOTTLE, PLASTIC; 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	04/08/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	03/20/2026

Labeler - Genexa Inc. (079751024)