Kids' Cough Daytime + Nighttime Combo

SPL v2

SPL

SPL Set ID 036fb529-3270-c649-e063-6394a90a2d74

Route

ORAL

Published

Effective Date 2024-02-06

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Dextromethorphan (5 mg) Guaifenesin (100 mg) Chlorpheniramine (2 mg)

Inactive Ingredients

Water Citrus Fruit Agave Tequilana Stem

Identifiers & Packaging

Pill Appearance

Color: brown

Marketing Status

OTC MONOGRAPH DRUG Active Since 2024-01-26

Description

Kids' Cough & Chest Congestion Drug Facts

Medication Information

Warnings and Precautions

Warnings

Indications and 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

Dosage and 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

Description

Kids' Cough & Chest Congestion Drug Facts

Section 42229-5

Kids' Cough & Chest Congestion

Drug Facts

Section 43683-2

Kids' Cough & Chest Congestion

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

Kids' Nighttime Cough

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

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

Section 44425-7

Other information

store between 20-25°C (68-77°F)

Section 50565-1

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)

Section 50566-9

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.

Section 50567-7

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

Section 50568-5

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

Section 50569-3

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

Section 50570-1

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.

Section 51727-6

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

Section 51945-4

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

Section 53413-1

Questions?

1-855-436-3921

Section 53414-9

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

Section 55105-1

Purposes

Cough suppressant

Expectorant

Section 55106-9

Active ingredients (in each 5 mL)

Dextromethorphan HBr, 5 mg

Guaifenesin, USP 100 mg

Structured Label Content

Indications and Usage (34067-9)

Uses

Dosage and Administration (34068-7)

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

Warnings and Precautions (34071-1)

Warnings

Section 42229-5 (42229-5)

Kids' Cough & Chest Congestion

Drug Facts

Section 43683-2 (43683-2)

Kids' Cough & Chest Congestion

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

Kids' Nighttime Cough

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

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

Section 44425-7 (44425-7)

Other information

store between 20-25°C (68-77°F)

Section 50565-1 (50565-1)

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)

Section 50566-9 (50566-9)

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.

Section 50567-7 (50567-7)

When using this product

Section 50568-5 (50568-5)

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

Section 50569-3 (50569-3)

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

Section 50570-1 (50570-1)

Section 51727-6 (51727-6)

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

Section 51945-4 (51945-4)

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

Section 53413-1 (53413-1)

Questions?

1-855-436-3921

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Purposes

Cough suppressant

Expectorant

Section 55106-9 (55106-9)

Active ingredients (in each 5 mL)

Dextromethorphan HBr, 5 mg

Guaifenesin, USP 100 mg

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"34067-9": "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", "34068-7": "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", "34071-1": "Warnings", "42229-5": "Kids' Cough & Chest Congestion Drug Facts", "43683-2": "Kids' Cough & Chest Congestion 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 Kids' Nighttime Cough 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 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", "44425-7": "Other information store between 20-25°C (68-77°F)", "50565-1": "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)", "50566-9": "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.", "50567-7": "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", "50568-5": "Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers", "50569-3": "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", "50570-1": "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.", "51727-6": "Inactive ingredients organic agave syrup, organic blueberry flavor, natural citrus extract, natural flavor, purified water", "51945-4": "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", "53413-1": "Questions? 1-855-436-3921", "53414-9": "If pregnant or breast-feeding, ask a health professional before use.", "55105-1": "Purposes Cough suppressant Expectorant", "55106-9": "Active ingredients (in each 5 mL) Dextromethorphan HBr, 5 mg Guaifenesin, USP 100 mg"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:46.038154 · Updated: 2026-03-14T23:02:29.359860