giltuss cough & cold

Drug Facts

Composition & Product

Active Ingredients

dextromethorphan (15 mg) guaifenesin (300 mg) phenylephrine (10 mg)

Inactive Ingredients

water polyethylene glycol, unspecified sorbitol sucralose anhydrous citric acid propylparaben propylene glycol methylparaben hydroxyethyl cellulose (2000 mpa.s at 1%) glycerin

Identifiers & Packaging

Marketing Status

otc monograph drug active Since 2018-10-02

Medication Information

Active Ingredient

Active ingredients (in each 5 mL)

Dextromethorphan HBr, 15 mg

Guaifenesin, 300 mg

Phenylephrine HCI, 10 mg

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 make cough more productive
temporarily relieves nasal congestion due to a cold

Dosage and Administration

Directions

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

adults and children 12 years & over	5 mL every 4 hours
children 6 to under 12 years of age	2.5 mL every 4 hours
children 2 to 6 years of age	1.25 mL every 4 hours
children under 2 years of age	Consult a doctor

Description

Drug Facts

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.In case of accident overdose, get medical or professional help or contact a Poison Control Center immediately.

Section 50566-9

Stop use and ask a doctor if

nervousness, dizziness, or sleeplessness occur
symptoms do not get better within 7 days or are accompanied by fever
cough lasts for more than 7 days, comes back, or occurs with fever, rash or persistant headache

These can be signs of a serious condition.

Section 50568-5

Ask a doctor or pharmacist before use if you aretaking any other oral nasal decongestant or stimulant, sedatives, tranquilizers, and drugs for depression, especially monoamine oxidase inhibitors (MAOIs).

Section 50569-3

Ask a doctor before use if you have

heart disease, high blood pressure, thyroid disease, or diabetes, or difficulty in urination due to enlargement of the prostate gland unless directed by a doctor
a cough with too much phlegm (mucus)
a persistent or chronic cough such as occurs with smoking, chronic bronchitis, or emphysema

Section 50570-1

Do not useif you are 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.

Section 51727-6

Inactive ingredients Citric acid, flavor, glycerin, hydroxyethylcellulose, methylparaben, polyethylene glycol, propylene glycol, propylparaben, purified water, sorbitol solution, and sucralose.

Section 51945-4

MAXIMUM STRENGTH

GILTUSS ^®

COUGH & COLD

ALCOHOL FREE. SUGAR FREE. DYE FREE

RELIEVES

COUGH AND COLD
CHEST CONGESTION
LOOSENS PHLEGM AND MUCUS
STUFFY NOSE
NASAL CONGESTION
SINUS PRESSURE

4 FL 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

Nasal Decongestant

Structured Label Content

Active Ingredient (55106-9)

Active ingredients (in each 5 mL)

Dextromethorphan HBr, 15 mg

Guaifenesin, 300 mg

Phenylephrine HCI, 10 mg

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 make cough more productive
temporarily relieves nasal congestion due to a cold

Dosage and Administration (34068-7)

Directions

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

adults and children 12 years & over	5 mL every 4 hours
children 6 to under 12 years of age	2.5 mL every 4 hours
children 2 to 6 years of age	1.25 mL every 4 hours
children under 2 years of age	Consult a doctor

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.In case of accident overdose, get medical or professional help or contact a Poison Control Center immediately.

Section 50566-9 (50566-9)

Stop use and ask a doctor if

nervousness, dizziness, or sleeplessness occur
symptoms do not get better within 7 days or are accompanied by fever
cough lasts for more than 7 days, comes back, or occurs with fever, rash or persistant headache

These can be signs of a serious condition.

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you aretaking any other oral nasal decongestant or stimulant, sedatives, tranquilizers, and drugs for depression, especially monoamine oxidase inhibitors (MAOIs).

Section 50569-3 (50569-3)

Ask a doctor before use if you have

heart disease, high blood pressure, thyroid disease, or diabetes, or difficulty in urination due to enlargement of the prostate gland unless directed by a doctor
a cough with too much phlegm (mucus)
a persistent or chronic cough such as occurs with smoking, chronic bronchitis, or emphysema

Section 50570-1 (50570-1)

Do not useif you are 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.

Section 51727-6 (51727-6)

Inactive ingredients Citric acid, flavor, glycerin, hydroxyethylcellulose, methylparaben, polyethylene glycol, propylene glycol, propylparaben, purified water, sorbitol solution, and sucralose.

Section 51945-4 (51945-4)

MAXIMUM STRENGTH

GILTUSS ^®

COUGH & COLD

ALCOHOL FREE. SUGAR FREE. DYE FREE

RELIEVES

COUGH AND COLD
CHEST CONGESTION
LOOSENS PHLEGM AND MUCUS
STUFFY NOSE
NASAL CONGESTION
SINUS PRESSURE

4 FL 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

Nasal Decongestant

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 as may occur with the common cold or inhaled irritants helps loosen phlegm (mucus) and thin bronchial secretions to make cough more productive temporarily relieves nasal congestion due to a cold", "34068-7": "Directions do not exceed recommended dosage do not take more than 6 doses in any 24 hour period keep dosing cup for use with this product mL = milliliters adults and children 12 years & over 5 mL every 4 hours children 6 to under 12 years of age 2.5 mL every 4 hours children 2 to 6 years of age 1.25 mL every 4 hours children under 2 years of age Consult a doctor", "42229-5": "Drug Facts", "50565-1": "Keep out of reach of children. In case of accident overdose, get medical or professional help or contact a Poison Control Center immediately.", "50566-9": "Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur symptoms do not get better within 7 days or are accompanied by fever cough lasts for more than 7 days, comes back, or occurs with fever, rash or persistant headache These can be signs of a serious condition.", "50568-5": "Ask a doctor or pharmacist before use if you are taking any other oral nasal decongestant or stimulant, sedatives, tranquilizers, and drugs for depression, especially monoamine oxidase inhibitors (MAOIs).", "50569-3": "Ask a doctor before use if you have heart disease, high blood pressure, thyroid disease, or diabetes, or difficulty in urination due to enlargement of the prostate gland unless directed by a doctor a cough with too much phlegm (mucus) a persistent or chronic cough such as occurs with smoking, chronic bronchitis, or emphysema", "50570-1": "Do not use if you are 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.", "51727-6": "Inactive ingredients Citric acid, flavor, glycerin, hydroxyethylcellulose, methylparaben, polyethylene glycol, propylene glycol, propylparaben, purified water, sorbitol solution, and sucralose.", "51945-4": "MAXIMUM STRENGTH GILTUSS ® COUGH & COLD ALCOHOL FREE. SUGAR FREE. DYE FREE RELIEVES COUGH AND COLD CHEST CONGESTION LOOSENS PHLEGM AND MUCUS STUFFY NOSE NASAL CONGESTION SINUS PRESSURE 4 FL 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 Nasal Decongestant", "55106-9": "Active ingredients (in each 5 mL) Dextromethorphan HBr, 15 mg Guaifenesin, 300 mg Phenylephrine HCI, 10 mg"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information