Llorens-tusnel Ped 544

Drug Facts

Composition & Product

Active Ingredients

Dextromethorphan (5 mg) Guaifenesin (50 mg) Pseudoephedrine (15 mg)

Inactive Ingredients

Citric Acid Monohydrate Methylparaben Propylene Glycol Propylparaben Water Sodium Citrate Sucralose

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2006-01-01

Medication Information

Warnings and Precautions

Warnings

Do not useif 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.

Indications and Usage

Uses

helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
temporarily relieves these symptoms occurring with a cold: nasal congestions, cough due to minor throat and bronchial irritation.

Dosage and Administration

DirectionsDo not exceed more than 4 doses in any 24-hour period

or as directed by a doctor.

Age	Weight	Dose
Children 6 to under 12 years of age	45 lbs to under 95 lbs	Take 2 teaspoonfuls (10 mL) every 4 to 6 hours
Children 2 to under 6 years of age	25 lbs to under 45 lbs	Take 1 teaspoonful (5mL) every 4 to 6 hours
Children under 2 years of age	Under 25 lbs	ask a doctor

Description

Active Ingredients(in each 5 ml tsp.) Purpose Dextromethorphan HBr........5mg..................................................Cough Suppressant Guaifenesin........................50mg................................................Expectorant Pseudoephedrine HCl..........15mg..................................................Nasal Decongestant

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 50570-1

Ask a doctor before use if your child has

heart disease
high blood pressure
thyroid disease
diabetes
a cough that occurs with too much phlegm (mucus)
a persistent or chronic cough such as occurs with asthma

When using this product

do not exceed recommended dosage

Stop use and ask a doctor if

nervousness, dizziness or sleeplessness occurs
symptoms do not get better within 7 days or accompanied by fever
cough last more than 7 days, comes back, or is accompanied by fever, rash or persistent headache. A persistent cough could be a sign of a serious condition.

Section 51727-6

Inactive ingredients astificial and natural flavor, citric acid, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate, and sucralos

Section 51945-4

Section 53413-1

Questions or Comments?1-866-595-5598

Section 55105-1

Purpose

Cough Suppressant

Expectorant

Nasal Decongestant

Section 55106-9

Active Ingredients(in each 5 ml tsp.) Purpose

Dextromethorphan HBr........5mg..................................................Cough Suppressant

Guaifenesin........................50mg................................................Expectorant

Pseudoephedrine HCl..........15mg..................................................Nasal Decongestant

Structured Label Content

Indications and Usage (34067-9)

Uses

helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
temporarily relieves these symptoms occurring with a cold: nasal congestions, cough due to minor throat and bronchial irritation.

Dosage and Administration (34068-7)

DirectionsDo not exceed more than 4 doses in any 24-hour period

or as directed by a doctor.

Age	Weight	Dose
Children 6 to under 12 years of age	45 lbs to under 95 lbs	Take 2 teaspoonfuls (10 mL) every 4 to 6 hours
Children 2 to under 6 years of age	25 lbs to under 45 lbs	Take 1 teaspoonful (5mL) every 4 to 6 hours
Children under 2 years of age	Under 25 lbs	ask a doctor

Warnings and Precautions (34071-1)

Warnings

Do not useif 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.

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 50570-1 (50570-1)

Ask a doctor before use if your child has

heart disease
high blood pressure
thyroid disease
diabetes
a cough that occurs with too much phlegm (mucus)
a persistent or chronic cough such as occurs with asthma

When using this product

do not exceed recommended dosage

Stop use and ask a doctor if

nervousness, dizziness or sleeplessness occurs
symptoms do not get better within 7 days or accompanied by fever
cough last more than 7 days, comes back, or is accompanied by fever, rash or persistent headache. A persistent cough could be a sign of a serious condition.

Section 51727-6 (51727-6)

Inactive ingredients astificial and natural flavor, citric acid, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate, and sucralos

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions or Comments?1-866-595-5598

Section 55105-1 (55105-1)

Purpose

Cough Suppressant

Expectorant

Nasal Decongestant

Section 55106-9 (55106-9)

Active Ingredients(in each 5 ml tsp.) Purpose

Dextromethorphan HBr........5mg..................................................Cough Suppressant

Guaifenesin........................50mg................................................Expectorant

Pseudoephedrine HCl..........15mg..................................................Nasal Decongestant

Advanced Ingredient Data

[{"name": "CITRIC ACID MONOHYDRATE", "unii": "2968PHW8QP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "METHYLPARABEN", "unii": "A2I8C7HI9T", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLPARABEN", "unii": "Z8IX2SC1OH", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM CITRATE", "unii": "1Q73Q2JULR", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SUCRALOSE", "unii": "96K6UQ3ZD4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DEXTROMETHORPHAN", "unii": "7355X3ROTS", "classCode": "ACTIB", "strengthNumerator": "5", "strengthDenominator": "5", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "GUAIFENESIN", "unii": "495W7451VQ", "classCode": "ACTIB", "strengthNumerator": "50", "strengthDenominator": "5", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "PSEUDOEPHEDRINE", "unii": "7CUC9DDI9F", "classCode": "ACTIB", "strengthNumerator": "15", "strengthDenominator": "5", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"34067-9": "Uses helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive temporarily relieves these symptoms occurring with a cold: nasal congestions, cough due to minor throat and bronchial irritation.", "34068-7": "Directions Do not exceed more than 4 doses in any 24-hour period or as directed by a doctor. Age Weight Dose Children 6 to under 12 years of age 45 lbs to under 95 lbs Take 2 teaspoonfuls (10 mL) every 4 to 6 hours Children 2 to under 6 years of age 25 lbs to under 45 lbs Take 1 teaspoonful (5mL) every 4 to 6 hours Children under 2 years of age Under 25 lbs ask a doctor", "34071-1": "Warnings 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.", "50565-1": "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.", "50570-1": "Ask a doctor before use if your child has heart disease high blood pressure thyroid disease diabetes a cough that occurs with too much phlegm (mucus) a persistent or chronic cough such as occurs with asthma When using this product do not exceed recommended dosage Stop use and ask a doctor if nervousness, dizziness or sleeplessness occurs symptoms do not get better within 7 days or accompanied by fever cough last more than 7 days, comes back, or is accompanied by fever, rash or persistent headache. A persistent cough could be a sign of a serious condition.", "51727-6": "Inactive ingredients astificial and natural flavor, citric acid, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate, and sucralos", "53413-1": "Questions or Comments? 1-866-595-5598", "55105-1": "Purpose Cough Suppressant Expectorant Nasal Decongestant", "55106-9": "Active Ingredients(in each 5 ml tsp.) Purpose Dextromethorphan HBr........5mg..................................................Cough Suppressant Guaifenesin........................50mg................................................Expectorant Pseudoephedrine HCl..........15mg..................................................Nasal Decongestant"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information