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

Kids Cough Daytime Nighttime Combo by

Drug Labeling and Warnings

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

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Kids' Cough & Chest Congestion

Drug Facts

ACTIVE INGREDIENT

Active ingredients (in each 5 mL)

Dextromethorphan HBr, 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 make 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°C (68-77°F)

INACTIVE INGREDIENT

Inactive ingredients organic agave syrup, organic blueberry flavor, natural citrus extract, natural flavor, purified water

QUESTIONS

Questions?

1-855-436-3921

SPL UNCLASSIFIED SECTION

*This product is not manufactured or distributed by GlaxoSmithKline Consumer Healthcare Holdings (US) LLC, owner of the registered trademark Children's Robitussin® Cough & Chest Congestion DM.

SPL UNCLASSIFIED SECTION

Kids' Nighttime Cough

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 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°C (68-77°F)

INACTIVE INGREDIENT

Inactive ingredients

organic agave syrup, organic blueberry flavor, natural citrus extract, natural flavor, purified water

QUESTIONS

Questions? 1-855-436-3921

SPL UNCLASSIFIED SECTION

**This product is not manufactured or distributed by GlaxoSmithKline Consumer Healthcare Holdings (US) LLC, owner of the registered trademark Children's Robitussin® Nighttime Cough Long-Acting DM.

SPL UNCLASSIFIED SECTION

SHAKE WELL before each use.

Bottles are safety sealed with a perforated band around bottles. DO NOT use if bottle seals are disturbed or missing.

Patent Pending | Distributed by: Genexa Inc.

Atlanta, GA 30324 | genexa.com

Made in the USA with globally sourced ingredients

NDC: 69676-0090-9

PRINCIPAL DISPLAY PANEL

DAYTIME + NIGHTTIME VALUE PACK

Genexa®

MEDICINE MADE CLEAN

Ages 4+
Kids' Cough & Chest Congestion

Dextromethorphan HBr - Cough Suppressant

Guaifenesin - Expectorant

Cough

Mucus

Chest Congestion

Made with the same active ingredients as Children's Robitussin® Cough & Chest Congestion DM*

Medicine made clean

Same effective active ingredients, but no artificial fillers.

Organic Blueberry Flavor

4 fl oz (118 mL)

Dosing cup included

Ages 6+

Long-Acting
Kids' Nighttime Cough

Chlorpheniramine Maleate - Antihistamine

Dextromethorphan HBr - Cough Suppressant

Relieves Cough up to 8 Hours

Runny Nose

Sneezing

Made with the same active ingredients as Children's Robitussin® Nighttime Cough Long-Acting DM**

Medicine made clean

Same effective active ingredients, but no artificial fillers.

Organic Blueberry Flavor

4 fl oz (118 mL)

Dosing cup included

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69676-0090

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69676-0090-9	1 in 1 KIT	01/26/2024
1		1 in 1 BOTTLE; Type 0: Not a Combination Product

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	0 BOTTLE, PLASTIC	1 mL  in 5
Part 2	0 BOTTLE	1 mL  in 10

Part 1 of 2

KIDS COUGH AND CHEST CONGESTION 
dextromethorphan hbr, guaifenesin liquid

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

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

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CITRUS FRUIT (UNII: XDK00Z8012)
AGAVE TEQUILANA STEM (UNII: J026JA743Y)

Product Characteristics
Color	brown (GOLDEN)	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	M013	01/26/2024

Part 2 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
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U)	CHLORPHENIRAMINE MALEATE	2 mg  in 10 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	15 mg  in 10 mL

Inactive Ingredients
Ingredient Name	Strength
CITRUS FRUIT (UNII: XDK00Z8012)
WATER (UNII: 059QF0KO0R)
AGAVE TEQUILANA STEM (UNII: J026JA743Y)

Product Characteristics
Color	brown (GOLDEN)	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	M013	01/26/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M013	01/26/2024

Labeler - Genexa Inc. (079751024)