Agc-biorytuss 250

Drug Facts

Composition & Product

Active Ingredients

Chlorpheniramine (2 mg) Dextromethorphan (10 mg) Phenylephrine (5 mg)

Inactive Ingredients

Citric Acid Monohydrate Methylparaben Propylparaben Sodium Citrate Sucralose Fd&c Red No. 40 Propylene Glycol Water

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2012-08-01

Medication Information

Warnings and Precautions

Warnings

Ask doctor before use if you have

Cough that occurs with too much phlegm (mucus), or a breathing problem or persitent or chronic cough that lasts such as occurs with smoking, asthma, chronic bronchitis or emphysema.
Heart disease
High blood pressure
Thyroid Disease
Diabetes
Difficulty in urinating due to enlarged prostate gland
Glaucoma

Ask doctor or pharmacist before use if you are taking any other oral nasal decongestant or stimulant; taking sedatives or tranquilizers.

When using this product

Do not use more than directed
May cause marked drowsiness; avoid alcohol beverages; alcohol, sedatives and tranquilizers may increase drowsiness.
Be careful when driving a motor vehicle or operating machinery; excitability may occur, especially with children.

Indications and Usage

Uses

temporarily relieves cough due to minor throat and bronchial irritation occurring with a cold, and nasal congestion due to the common cold, hay fever or other upper respiratory allergies
temporarily relieves these symptoms due to hay fever (allergic rhinitis); runny nose; sneezing; itchy watery eyes; itching of the nose or throat
temporarily restores freer beathing through the nose.

Dosage and Administration

Directionsdo not take more than 6 doses in any 24 hour period

adults and children

12 years of age

2 teaspoonful (10 mL)

every 4-6 hours

children 6 to under

12 years of age

1 teaspoonful (5 mL)

every 4-6 hours

children 2 to under 6 years of age

1/2 teaspoonful (2.5 mL)

every 4-6 hours

Description

Active ingredients (in each 5 mL tsp.) Purpose Chlorpheniramine Maleate 2 mg Antihistamine Dextromethorphan Hydrobromide 10 mg Cough Suppressant Phenylephrine Hydrochloride 5 mg Nasal Decongestant

Section 50565-1

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

Section 50570-1

Do not use

To sedate a child or to make a child sleepy
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 that contains an MAOI, ask your doctor or pharmacist before taking this product

Stop use and ask a doctor if you

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

Section 51727-6

Inactive ingredients

Citric acid, FD&C Red #40, flavor, methylparaben, propylene glycol, propylparaben, purified water, Sodium citrate, sucralose.

Section 51945-4

Section 53413-1

Questions or comments?

1-305-403-3788

Section 53414-9

If pregnant or breast-feeding,ask a doctor before use

Section 55105-1

Purpose

Antihistamine

Cough Suppressant

Nasal Decongestant

Section 55106-9

Active ingredients (in each 5 mL tsp.) Purpose

Chlorpheniramine Maleate 2 mg Antihistamine

Dextromethorphan Hydrobromide 10 mg Cough Suppressant

Phenylephrine Hydrochloride 5 mg Nasal Decongestant

Structured Label Content

Indications and Usage (34067-9)

Uses

temporarily relieves cough due to minor throat and bronchial irritation occurring with a cold, and nasal congestion due to the common cold, hay fever or other upper respiratory allergies
temporarily relieves these symptoms due to hay fever (allergic rhinitis); runny nose; sneezing; itchy watery eyes; itching of the nose or throat
temporarily restores freer beathing through the nose.

Dosage and Administration (34068-7)

Directionsdo not take more than 6 doses in any 24 hour period

adults and children

12 years of age

2 teaspoonful (10 mL)

every 4-6 hours

children 6 to under

12 years of age

1 teaspoonful (5 mL)

every 4-6 hours

children 2 to under 6 years of age

1/2 teaspoonful (2.5 mL)

every 4-6 hours

Warnings and Precautions (34071-1)

Warnings

Ask doctor before use if you have

Cough that occurs with too much phlegm (mucus), or a breathing problem or persitent or chronic cough that lasts such as occurs with smoking, asthma, chronic bronchitis or emphysema.
Heart disease
High blood pressure
Thyroid Disease
Diabetes
Difficulty in urinating due to enlarged prostate gland
Glaucoma

Ask doctor or pharmacist before use if you are taking any other oral nasal decongestant or stimulant; taking sedatives or tranquilizers.

When using this product

Do not use more than directed
May cause marked drowsiness; avoid alcohol beverages; alcohol, sedatives and tranquilizers may increase drowsiness.
Be careful when driving a motor vehicle or operating machinery; excitability may occur, especially with children.

Section 50565-1 (50565-1)

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

Section 50570-1 (50570-1)

Do not use

To sedate a child or to make a child sleepy
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 that contains an MAOI, ask your doctor or pharmacist before taking this product

Stop use and ask a doctor if you

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

Section 51727-6 (51727-6)

Inactive ingredients

Citric acid, FD&C Red #40, flavor, methylparaben, propylene glycol, propylparaben, purified water, Sodium citrate, sucralose.

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 doctor before use

Section 55105-1 (55105-1)

Purpose

Antihistamine

Cough Suppressant

Nasal Decongestant

Section 55106-9 (55106-9)

Active ingredients (in each 5 mL tsp.) Purpose

Chlorpheniramine Maleate 2 mg Antihistamine

Dextromethorphan Hydrobromide 10 mg Cough Suppressant

Phenylephrine Hydrochloride 5 mg 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 occurring with a cold, and nasal congestion due to the common cold, hay fever or other upper respiratory allergies temporarily relieves these symptoms due to hay fever (allergic rhinitis); runny nose; sneezing; itchy watery eyes; itching of the nose or throat temporarily restores freer beathing through the nose.", "34068-7": "Directions do not take more than 6 doses in any 24 hour period adults and children 12 years of age 2 teaspoonful (10 mL) every 4-6 hours children 6 to under 12 years of age 1 teaspoonful (5 mL) every 4-6 hours children 2 to under 6 years of age 1/2 teaspoonful (2.5 mL) every 4-6 hours", "34071-1": "Warnings Ask doctor before use if you have Cough that occurs with too much phlegm (mucus), or a breathing problem or persitent or chronic cough that lasts such as occurs with smoking, asthma, chronic bronchitis or emphysema. Heart disease High blood pressure Thyroid Disease Diabetes Difficulty in urinating due to enlarged prostate gland Glaucoma Ask doctor or pharmacist before use if you are taking any other oral nasal decongestant or stimulant; taking sedatives or tranquilizers. When using this product Do not use more than directed May cause marked drowsiness; avoid alcohol beverages; alcohol, sedatives and tranquilizers may increase drowsiness. Be careful when driving a motor vehicle or operating machinery; excitability may occur, especially with children.", "50565-1": "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately", "50570-1": "Do not use To sedate a child or to make a child sleepy 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 that contains an MAOI, ask your doctor or pharmacist before taking this product Stop use and ask a doctor if you you get nervous, dizzy or sleepless symptoms do not get better within 7 days or are accompanied by fever cough lasts more than 7 days, comes back, or is accompanied by fever, rash or persistent headaches. These could be signs of a serious condition.", "51727-6": "Inactive ingredients Citric acid, FD&C Red #40, flavor, methylparaben, propylene glycol, propylparaben, purified water, Sodium citrate, sucralose.", "53413-1": "Questions or comments? 1-305-403-3788", "53414-9": "If pregnant or breast-feeding, ask a doctor before use", "55105-1": "Purpose Antihistamine Cough Suppressant Nasal Decongestant", "55106-9": "Active ingredients (in each 5 mL tsp.) Purpose Chlorpheniramine Maleate 2 mg Antihistamine Dextromethorphan Hydrobromide 10 mg Cough Suppressant Phenylephrine Hydrochloride 5 mg Nasal Decongestant"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information