FDA Label for Kids Cough Daytime Nighttime Combo

Other

Kids' Cough & Chest Congestion

Drug Facts

**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.

Kids' Nighttime Cough

Drug Facts

**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.

SHAKE WELL before each use.

Bottle is safety sealed with a perforated band around bottle. DO NOT use if bottle seal is disturbed or missing.

Patent Pending | Distributed by: Genexa Inc.

Atlanta, GA 30324 | genexa.com

Made in the USA with globally sourced ingredients

NDC 69676-0090-9

Otc - Active Ingredient

Active ingredients (in each 5 mL)

Dextromethorphan HBr, USP 5 mg

Guaifenesin, USP 100 mg

Active Ingredients (in each 10 mL)

Chlorpheniramine maleate, USP 2 mg

Dextromethorphan HBr, 15 mg

Otc - Purpose

Purposes

Cough suppressant

Expectorant

Purposes

Antihistamine

Cough suppressant

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

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

Warnings

Otc - Do Not Use

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.

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.

Otc - Ask Doctor

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

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

Otc - Stop Use

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.

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.

Otc - Keep Out Of Reach Of Children

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)

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
• 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

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)

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

Inactive ingredients

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

Otc - Questions

Questions?

1-855-436-3921

Questions? 1-855-436-3921

Otc - Ask Doctor/Pharmacist

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

Otc - When Using

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

Otc - Pregnancy Or Breast Feeding

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

Recent Major Changes

Kids' Cough & Chest Congestion

Directions

SHAKE WELL BEFORE USING
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

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 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

Package Label.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