Kids' Nighttime Cough

Kids' Nighttime Cough
SPL v4
SPL
SPL Set ID 024bb864-4214-1d8b-e063-6394a90aa573
Route
ORAL
Published
Effective Date 2025-10-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dextromethorphan (15 mg) Chlorpheniramine (2 mg)
Inactive Ingredients
Agave Tequilana Stem Water Blueberry

Identifiers & Packaging

Pill Appearance
Color: brown
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-05-06

Description

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 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

Dosage and 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

Description

Drug Facts

Section 42229-5

Drug Facts

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 is accompanied by fever,

rash, or persistent headache. 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 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

Section 50570-1

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

Section 51727-6

Inactive ingredients

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

Section 51945-4

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)

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

Antihistamine

Cough suppressant

Section 55106-9

Active ingredients (in each 10 mL)

Chlorpheniramine maleate, USP 2 mg

Dextromethorphan HBr, USP 15 mg


Structured Label Content

Indications and Usage (34067-9)

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

Dosage and Administration (34068-7)

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

Warnings and Precautions (34071-1)

Warnings

Section 42229-5 (42229-5)

Drug Facts

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 is accompanied by fever,

rash, or persistent headache. These could be signs of a serious condition.

Section 50567-7 (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 (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 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

Section 50570-1 (50570-1)

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

Section 51727-6 (51727-6)

Inactive ingredients

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

Section 51945-4 (51945-4)

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)

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

Antihistamine

Cough suppressant

Section 55106-9 (55106-9)

Active ingredients (in each 10 mL)

Chlorpheniramine maleate, USP 2 mg

Dextromethorphan HBr, USP 15 mg


Advanced Ingredient Data


Raw Label Data

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