Kids' Cough & Chest Congestion

Kids' Cough & Chest Congestion
SPL v11
SPL
SPL Set ID a7ab2140-de09-158f-e053-2a95a90a25a0
Route
ORAL
Published
Effective Date 2025-06-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Pill Appearance
Color: brown
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-04-08

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

  • 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
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 42229-5

Drug Facts

Section 43683-2

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
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

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 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 flavors, purified water

Section 51945-4

Genexa ®

MEDICINE MADE CLEAN

Kids' Cough & Chest Congestion

Ages 4-11

Dextromethorphan HBr - Cough Suppressant

Guaifenesin - Expectorant

Cough

Mucus

Chest Congestion

Same effective active ingredients as leading brands

0% Artificial Additives

Always free of common allergens, artificial preservatives, flavors, & dyes

4 FL OZ (118 mL)

Organic Blueberry Flavor

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

  • 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
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)

Drug Facts

Section 43683-2 (43683-2)

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
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

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 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 flavors, purified water

Section 51945-4 (51945-4)

Genexa ®

MEDICINE MADE CLEAN

Kids' Cough & Chest Congestion

Ages 4-11

Dextromethorphan HBr - Cough Suppressant

Guaifenesin - Expectorant

Cough

Mucus

Chest Congestion

Same effective active ingredients as leading brands

0% Artificial Additives

Always free of common allergens, artificial preservatives, flavors, & dyes

4 FL OZ (118 mL)

Organic Blueberry Flavor

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

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