Giltuss Children's Cough & Chest Congestion

Drug Facts

Composition & Product

Active Ingredients

Dextromethorphan (10 mg) Guaifenesin (100 mg)

Inactive Ingredients

D&c Red No. 33 Water Sucrose Anhydrous Citric Acid Propylparaben Propylene Glycol Methylparaben

Identifiers & Packaging

Pill Appearance

Color: pink

Marketing Status

OTC MONOGRAPH DRUG Active Since 2018-10-02

Medication Information

Indications and Usage

Uses

temporarily relieves
cough due to minor throat and bronchial irritation associated with the common cold or inhaled irritants
the intensity of coughing
the impulse to cough to help your child get to sleep
helps loosen phlegm (mucus) and thin bronchial secretions to make cough more productive and drain bronchial tubes

Dosage and Administration

Directions

do not take more than 6 doses in any 24 hour period
use enclosed dosing cup
keep dosing cup for use with this product
mL = milliliters

children under 2 years	Consult a doctor
children 2 to under 6 years of age	2.5 mL every 4 hours
children 6 to under 12 years of age	5 mL every 4 hours
children 12 years and over	10 mL every 4 hours

Description

Drug Facts

Section 42229-5

Drug Facts

Section 50565-1

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

Section 50566-9

Stop use and ask a doctor or pharmacist if the child has

symptoms do not get better within 7 days or are accompanied by fever
cough 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.

Section 50569-3

Ask a doctor before use if the child has

cough that occurs with too much phlegm (mucus)
a breathing problem or persistent or chronic cough that lasts such as occurs with asthma

Section 50570-1

Do not useif your child is 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 child's prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Section 51727-6

Inactive ingredients Citric acid, flavor, D&C red #33, flavor, methylparaben, propylene glycol, propylparaben, purified water, and sucrose

Section 51945-4

Children's

GILTUSS ^®

COUGH & CHEST CONGESTION

ANTITUSSIVE AND EXPECTORANT

Non-Drowsy. Alcohol Free

COUGH AND COLD
CHEST CONGESTION
LIQUIFIES AND LOOSENS PHLEGM AND MUCUS

RASPBERRY FLAVOR

4FL OZ (118 mL)

Section 53413-1

Questions or comments?

Call 1-787-848-9114, Monday - Friday 9AM - 5PM EST. Call your doctor for medical advice in the event of side effects.

Section 53414-9

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

Section 55105-1

Purposes

Cough Suppressant

Expectorant

Section 55106-9

Active ingredients (in each 5 mL)

Dextromethorphan HBr, 10 mg

Guaifenesin, 100 mg

Structured Label Content

Indications and Usage (34067-9)

Uses

temporarily relieves
cough due to minor throat and bronchial irritation associated with the common cold or inhaled irritants
the intensity of coughing
the impulse to cough to help your child get to sleep
helps loosen phlegm (mucus) and thin bronchial secretions to make cough more productive and drain bronchial tubes

Dosage and Administration (34068-7)

Directions

do not take more than 6 doses in any 24 hour period
use enclosed dosing cup
keep dosing cup for use with this product
mL = milliliters

children under 2 years	Consult a doctor
children 2 to under 6 years of age	2.5 mL every 4 hours
children 6 to under 12 years of age	5 mL every 4 hours
children 12 years and over	10 mL every 4 hours

Section 42229-5 (42229-5)

Drug Facts

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.

Section 50566-9 (50566-9)

Stop use and ask a doctor or pharmacist if the child has

symptoms do not get better within 7 days or are accompanied by fever
cough 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.

Section 50569-3 (50569-3)

Ask a doctor before use if the child has

cough that occurs with too much phlegm (mucus)
a breathing problem or persistent or chronic cough that lasts such as occurs with asthma

Section 50570-1 (50570-1)

Do not useif your child is 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 child's prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Section 51727-6 (51727-6)

Inactive ingredients Citric acid, flavor, D&C red #33, flavor, methylparaben, propylene glycol, propylparaben, purified water, and sucrose

Section 51945-4 (51945-4)

Children's

GILTUSS ^®

COUGH & CHEST CONGESTION

ANTITUSSIVE AND EXPECTORANT

Non-Drowsy. Alcohol Free

COUGH AND COLD
CHEST CONGESTION
LIQUIFIES AND LOOSENS PHLEGM AND MUCUS

RASPBERRY FLAVOR

4FL OZ (118 mL)

Section 53413-1 (53413-1)

Questions or comments?

Call 1-787-848-9114, Monday - Friday 9AM - 5PM EST. Call your doctor for medical advice in the event of side effects.

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Purposes

Cough Suppressant

Expectorant

Section 55106-9 (55106-9)

Active ingredients (in each 5 mL)

Dextromethorphan HBr, 10 mg

Guaifenesin, 100 mg

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"34067-9": "Uses temporarily relieves cough due to minor throat and bronchial irritation associated with the common cold or inhaled irritants the intensity of coughing the impulse to cough to help your child get to sleep helps loosen phlegm (mucus) and thin bronchial secretions to make cough more productive and drain bronchial tubes", "34068-7": "Directions do not take more than 6 doses in any 24 hour period use enclosed dosing cup keep dosing cup for use with this product mL = milliliters children under 2 years Consult a doctor children 2 to under 6 years of age 2.5 mL every 4 hours children 6 to under 12 years of age 5 mL every 4 hours children 12 years and over 10 mL every 4 hours", "42229-5": "Drug Facts", "50565-1": "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.", "50566-9": "Stop use and ask a doctor or pharmacist if the child has symptoms do not get better within 7 days or are accompanied by fever cough comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.", "50567-7": "When using this product do not use more than directed.", "50569-3": "Ask a doctor before use if the child has cough that occurs with too much phlegm (mucus) a breathing problem or persistent or chronic cough that lasts such as occurs with asthma", "50570-1": "Do not use if your child is 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 child's prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.", "51727-6": "Inactive ingredients Citric acid, flavor, D&C red #33, flavor, methylparaben, propylene glycol, propylparaben, purified water, and sucrose", "51945-4": "Children's GILTUSS ® COUGH & CHEST CONGESTION ANTITUSSIVE AND EXPECTORANT Non-Drowsy. Alcohol Free COUGH AND COLD CHEST CONGESTION LIQUIFIES AND LOOSENS PHLEGM AND MUCUS RASPBERRY FLAVOR 4FL OZ (118 mL)", "53413-1": "Questions or comments? Call 1-787-848-9114 , Monday - Friday 9AM - 5PM EST. Call your doctor for medical advice in the event of side effects.", "53414-9": "If pregnant or breast-feeding, ask a health professional before use.", "55105-1": "Purposes Cough Suppressant Expectorant", "55106-9": "Active ingredients (in each 5 mL) Dextromethorphan HBr, 10 mg Guaifenesin, 100 mg"}

Giltuss Children's Cough & Chest Congestion

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information