Children's Cough & Chest Congestion

Children's Cough & Chest Congestion
SPL v1
SPL
SPL Set ID 2d95d5a4-34dc-e195-e063-6394a90a39da
Route
ORAL
Published
Effective Date 2025-02-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dextromethorphan (5 mg) Guaifenesin (100 mg)
Inactive Ingredients
Agave Tequilana Juice Water Citrus Fruit Blueberry

Identifiers & Packaging

Pill Appearance
Color: brown
Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-09-01

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 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

  • 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
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

Drug Facts

Section 34088-5

In case of overdose, get medical help or contact a Poison Control Center right away.

(1-800-222-1222)

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.

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 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, flavor, purified water

Section 51945-4

Children's

Genexa®

MEDICINE MADE CLEAN

Ages 4-11

Cough & Chest Congestion

Dextromethorphan HBr | Guaifenesin

Cough Suppressant - Expectorant

Mucus

Chest Congestion

Compare to active ingredients in Children's Robitussin® Cough & Chest Congestion DM*

How we're different

Made without: sodium benzoate, propylene glycol, sucralose & more!

Organic Blueberry Flavor

4 fl oz (118 mL) Dosing cup included

Section 53413-1

Questions? 1-855-436-3921

Section 55105-1

Purpose

Cough suppressant

Expectorant

Section 55106-9

Active ingredients

(in each 5 mL)

Dextromethorphan HBr, USP 5 mg

Guaifenesin, USP 100 mg


Structured Label Content

Indications and Usage (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
Dosage and Administration (34068-7)

Directions

  • 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
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 34088-5 (34088-5)

In case of overdose, get medical help or contact a Poison Control Center right away.

(1-800-222-1222)

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.

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 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)

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 (51727-6)

Inactive ingredients

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

Section 51945-4 (51945-4)

Children's

Genexa®

MEDICINE MADE CLEAN

Ages 4-11

Cough & Chest Congestion

Dextromethorphan HBr | Guaifenesin

Cough Suppressant - Expectorant

Mucus

Chest Congestion

Compare to active ingredients in Children's Robitussin® Cough & Chest Congestion DM*

How we're different

Made without: sodium benzoate, propylene glycol, sucralose & more!

Organic Blueberry Flavor

4 fl oz (118 mL) Dosing cup included

Section 53413-1 (53413-1)

Questions? 1-855-436-3921

Section 55105-1 (55105-1)

Purpose

Cough suppressant

Expectorant

Section 55106-9 (55106-9)

Active ingredients

(in each 5 mL)

Dextromethorphan HBr, USP 5 mg

Guaifenesin, USP 100 mg


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)