Agc-biocotrondsus 208

Drug Facts

Composition & Product

Active Ingredients

Dextromethorphan (10 mg) Guaifenesin (200 mg) Phenylephrine (5 mg)

Inactive Ingredients

Citric Acid Monohydrate Carboxymethylcellulose Sodium Powdered Cellulose Sodium Benzoate Propylene Glycol Saccharin Sodium Water

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2013-03-01

Medication Information

Warnings and Precautions

Warnings:

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 last or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema.

Ask doctor or pharmacist before useif you are taking any other nasal decongestant or stimulant.

When using this product do not use more than directed.

Indications and Usage

Other information:Store at room temperature 15-30 degrees C (59-86 degrees F)

Tamper evident:Do not use if seal under cap (or cello-band over cap) is torn, broken or missing.

Each teaspoonful (5mL) contains:Sodium 6 mg

Dosage and Administration

Directions:Do not take more than 3 doses in any 24-hour period.

Age	Dose
Adults and children 12 years of age and over	2 teaspoons every 4 hours
Children 6 to under 12 years of age	1 teaspoon every 4 hours
Children 2 to under 6 years of age	1/2 teaspoon every 4 hours
Children under 2 years of age	Ask a doctor

Description

Active Ingredients (in each 5mL) Purpose Dextromethorphan HBr, 10 mg ................................. Cough Suppressant Guaifenesin, 200 mg ................................................ Expectorant Phenylephrine HCl, 5 mg ...................................... Nasal Decongestant

Section 50565-1

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

Section 50570-1

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

Stop use and ask a doctor before use if:

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

Section 51727-6

Inactive ingredients:Carboxymethyl cellulose sodium, Cellulose, Citric Acid, Flavor, Propylene Glycol, Sodium Benzoate, Sodium Saccharin, Water

Section 51945-4

Section 53413-1

Questions or comments?1-305-403-3788

Section 53414-9

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

Section 55105-1

Uses

Helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes. Temporarily relieves cough due to minor throat and bronchial irritation as may occur with the common cold. Temporarily relieves nasal congestion due to the common cold.

Section 55106-9

Active Ingredients (in each 5mL) Purpose

Dextromethorphan HBr, 10 mg ................................. Cough Suppressant

Guaifenesin, 200 mg ................................................ Expectorant

Phenylephrine HCl, 5 mg ...................................... Nasal Decongestant

Structured Label Content

Indications and Usage (34067-9)

Other information:Store at room temperature 15-30 degrees C (59-86 degrees F)

Tamper evident:Do not use if seal under cap (or cello-band over cap) is torn, broken or missing.

Each teaspoonful (5mL) contains:Sodium 6 mg

Dosage and Administration (34068-7)

Directions:Do not take more than 3 doses in any 24-hour period.

Age	Dose
Adults and children 12 years of age and over	2 teaspoons every 4 hours
Children 6 to under 12 years of age	1 teaspoon every 4 hours
Children 2 to under 6 years of age	1/2 teaspoon every 4 hours
Children under 2 years of age	Ask a doctor

Warnings and Precautions (34071-1)

Warnings:

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 last or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema.

Ask doctor or pharmacist before useif you are taking any other nasal decongestant or stimulant.

When using this product do not use more than directed.

Section 50565-1 (50565-1)

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

Section 50570-1 (50570-1)

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

Stop use and ask a doctor before use if:

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

Section 51727-6 (51727-6)

Inactive ingredients:Carboxymethyl cellulose sodium, Cellulose, Citric Acid, Flavor, Propylene Glycol, Sodium Benzoate, Sodium Saccharin, Water

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions or comments?1-305-403-3788

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Uses

Helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes. Temporarily relieves cough due to minor throat and bronchial irritation as may occur with the common cold. Temporarily relieves nasal congestion due to the common cold.

Section 55106-9 (55106-9)

Active Ingredients (in each 5mL) Purpose

Dextromethorphan HBr, 10 mg ................................. Cough Suppressant

Guaifenesin, 200 mg ................................................ Expectorant

Phenylephrine HCl, 5 mg ...................................... Nasal Decongestant

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"34067-9": "Other information: Store at room temperature 15-30 degrees C (59-86 degrees F) Tamper evident: Do not use if seal under cap (or cello-band over cap) is torn, broken or missing. Each teaspoonful (5mL) contains: Sodium 6 mg", "34068-7": "Directions: Do not take more than 3 doses in any 24-hour period. Age Dose Adults and children 12 years of age and over 2 teaspoons every 4 hours Children 6 to under 12 years of age 1 teaspoon every 4 hours Children 2 to under 6 years of age 1/2 teaspoon every 4 hours Children under 2 years of age Ask a doctor", "34071-1": "Warnings : 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 last or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema. Ask doctor or pharmacist before use if you are taking any other nasal decongestant or stimulant. When using this product do not use more than directed.", "50565-1": "Keep out of the reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away.", "50570-1": "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 you are taking a prescription drug that contains an MAOI, ask a doctor or pharmacist before taking this product. Stop use and ask a doctor before use if: you get nervous, dizzy or sleepless; symptoms do not get better within 7 or are accompanied by fever cough lasts more than 7 days, comes back, or is accompanied by fever, rash or persistent headache. These could be signs of a serious condition.", "51727-6": "Inactive ingredients: Carboxymethyl cellulose sodium, Cellulose, Citric Acid, Flavor, Propylene Glycol, Sodium Benzoate, Sodium Saccharin, Water", "53413-1": "Questions or comments? 1-305-403-3788", "53414-9": "If pregnant or breast-feeding, ask a health professional before use.", "55105-1": "Uses Helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes. Temporarily relieves cough due to minor throat and bronchial irritation as may occur with the common cold. Temporarily relieves nasal congestion due to the common cold.", "55106-9": "Active Ingredients (in each 5mL) Purpose Dextromethorphan HBr, 10 mg ................................. Cough Suppressant Guaifenesin, 200 mg ................................................ Expectorant Phenylephrine HCl, 5 mg ...................................... Nasal Decongestant"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information