Kids' Cough & Chest Congestion Organic Cherry Flavor

Kids' Cough & Chest Congestion Organic Cherry Flavor
SPL v1
SPL
SPL Set ID 0247cd44-fd97-72df-e063-6294a90a1e87
Route
ORAL
Published
Effective Date 2023-08-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Pill Appearance
Color: brown
Marketing Status
OTC MONOGRAPH FINAL Active Since 2023-08-06
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 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 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
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 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 cherry flavor, natural citrus extract, natural flavor, purified water

Section 51945-4

Genexa®

MEDICINE MADE CLEAN

Ages 4-11



Kids' Cough & Chest Congestion

Dextromethorphan HBr | Guaifenesin

Cough Suppressant - 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 Cherry Flavor

4 FL OZ (118 mL)

Dosing cup included

Section 53413-1

Questions?

1-855-436-3921

Section 55105-1

Purposes

Cough suppressant

Expectorant

Section 55106-9

Active ingredients (in each 5 mL)

Dextromethorphan HBr, USP 5 mg

Guaifenesin, USP 100 mg

Directions

Added "SHAKE WELL BEFORE USING" under Directions

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 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
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 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 cherry flavor, natural citrus extract, natural flavor, purified water

Section 51945-4 (51945-4)

Genexa®

MEDICINE MADE CLEAN

Ages 4-11



Kids' Cough & Chest Congestion

Dextromethorphan HBr | Guaifenesin

Cough Suppressant - 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 Cherry Flavor

4 FL OZ (118 mL)

Dosing cup included

Section 53413-1 (53413-1)

Questions?

1-855-436-3921

Section 55105-1 (55105-1)

Purposes

Cough suppressant

Expectorant

Section 55106-9 (55106-9)

Active ingredients (in each 5 mL)

Dextromethorphan HBr, USP 5 mg

Guaifenesin, USP 100 mg

Directions (DIRECTIONS)

Added "SHAKE WELL BEFORE USING" under Directions

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:01:06.950744 · Updated: 2026-03-14T23:01:17.657881