drug facts

Composition & Product

Active Ingredients

dextromethorphan (10 mg) guaifenesin (100 mg) phenylephrine (5 mg)

Inactive Ingredients

anhydrous citric acid fd&c red no. 40 menthol saccharin sodium sodium benzoate water glycerin

Identifiers & Packaging

Pill Appearance

Color: red

Marketing Status

otc monograph final active Since 1999-03-16

Medication Information

Uses

helps loosen phlegm (mucus) and thin bronchial secretions to to drain bronchial tubes

temporarily relieves these symptoms occuring with a cold

nasal congestion

cough due to minor throat and bronchial irritation

Purpose

Cough suppressant

Expectorant

Nasal decongestant

Directions

do not take more than 6 doses in any 24-hour period

age	dose
adults and children 12 years and over	2 teaspoonfuls every 4 hours
children 6 years to under 12 years	1 teaspoonful every 4 hours
children 2 years to under 6 years	1/2 teaspoonful every 4 hours
children under 2 years	ask a doctor

Other Information

•
TAMPER EVIDENT: DO NOT USE IF BREAKAWAY BAND ON CAP IS BROKEN OR MISSING
•
store at room temperature 15º - 30ºC (59º - 86ºF)
•
alocohol free
•
not a USP elixir
•
each teaspoon (5 mL) contains: sodium 2 mg.

Inactive Ingredients

citric acid, FD&C red no. 40, , flavors, glycerin, menthol, propylene glycol, sodium benzoate, sodium saccharin, water

Description

Dextromethorphan HBr, USP 10 mg Guaifenesin, USP 100 mg Phenylephrine HCl, USP 5 mg

Principal Display Panel

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 50567-7

When using this product do not use more than directed.

Section 50569-3

Ask a doctor before use if you have

heart disease
high blood pressure
thyroid disease
diabetes
trouble urinating due to an enlarged prostate gland
cough that occurs with too much phlegm (mucus)
cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema

Section 53414-9

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

Do Not Use

if you are 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 prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Stop Use and Ask A Doctor If

you get nervous, dizzy, or sleepless
symptoms do not get better within 7 days or are accompanied by fever
cough that lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.

Active Ingredient (in Each 5 Mltsp)

Dextromethorphan HBr, USP 10 mg

Guaifenesin, USP 100 mg

Phenylephrine HCl, USP 5 mg

Structured Label Content

Uses

helps loosen phlegm (mucus) and thin bronchial secretions to to drain bronchial tubes

temporarily relieves these symptoms occuring with a cold

nasal congestion

cough due to minor throat and bronchial irritation

Purpose

Cough suppressant

Expectorant

Nasal decongestant

Directions

do not take more than 6 doses in any 24-hour period

age	dose
adults and children 12 years and over	2 teaspoonfuls every 4 hours
children 6 years to under 12 years	1 teaspoonful every 4 hours
children 2 years to under 6 years	1/2 teaspoonful every 4 hours
children under 2 years	ask a doctor

Other Information (Other information)

•
TAMPER EVIDENT: DO NOT USE IF BREAKAWAY BAND ON CAP IS BROKEN OR MISSING
•
store at room temperature 15º - 30ºC (59º - 86ºF)
•
alocohol free
•
not a USP elixir
•
each teaspoon (5 mL) contains: sodium 2 mg.

Inactive Ingredients (Inactive ingredients)

citric acid, FD&C red no. 40, , flavors, glycerin, menthol, propylene glycol, sodium benzoate, sodium saccharin, water

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

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 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 you have

heart disease
high blood pressure
thyroid disease
diabetes
trouble urinating due to an enlarged prostate gland
cough that occurs with too much phlegm (mucus)
cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema

Section 53414-9 (53414-9)

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

Do Not Use (Do not use)

if you are 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 prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

you get nervous, dizzy, or sleepless
symptoms do not get better within 7 days or are accompanied by fever
cough that lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.

Active Ingredient (in Each 5 Mltsp) (Active ingredient (in each 5 mLtsp))

Dextromethorphan HBr, USP 10 mg

Guaifenesin, USP 100 mg

Phenylephrine HCl, USP 5 mg

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"Uses": "helps loosen phlegm (mucus) and thin bronchial secretions to to drain bronchial tubes temporarily relieves these symptoms occuring with a cold nasal congestion cough due to minor throat and bronchial irritation", "50565-1": "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.", "50567-7": "When using this product do not use more than directed.", "50569-3": "Ask a doctor before use if you have heart disease high blood pressure thyroid disease diabetes trouble urinating due to an enlarged prostate gland cough that occurs with too much phlegm (mucus) cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema", "53414-9": "If pregnant or breast-feeding, ask a health professional before use.", "Purpose": "Cough suppressant Expectorant Nasal decongestant", "Directions": "do not take more than 6 doses in any 24-hour period age dose adults and children 12 years and over 2 teaspoonfuls every 4 hours children 6 years to under 12 years 1 teaspoonful every 4 hours children 2 years to under 6 years 1/2 teaspoonful every 4 hours children under 2 years ask a doctor", "Do not use": "if you are 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 prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.", "Other information": "• TAMPER EVIDENT: DO NOT USE IF BREAKAWAY BAND ON CAP IS BROKEN OR MISSING • store at room temperature 15º - 30ºC (59º - 86ºF) • alocohol free • not a USP elixir • each teaspoon (5 mL) contains: sodium 2 mg.", "Inactive ingredients": "citric acid, FD&C red no. 40, , flavors, glycerin, menthol, propylene glycol, sodium benzoate, sodium saccharin, water", "Stop use and ask a doctor if": "you get nervous, dizzy, or sleepless symptoms do not get better within 7 days or are accompanied by fever cough that lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.", "Active ingredient (in each 5 mLtsp)": "Dextromethorphan HBr, USP 10 mg Guaifenesin, USP 100 mg Phenylephrine HCl, USP 5 mg"}