Alt-altipresped 103

Drug Facts

Composition & Product

Active Ingredients

Dextromethorphan (5 mg) Guaifenesin (75 mg) Phenylephrine (2.5 mg)

Inactive Ingredients

Sucralose Citric Acid Monohydrate Methylparaben Propylene Glycol Propylparaben Water Sodium Citrate

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2013-05-01

Medication Information

Warnings and Precautions

Warnings

Ask a doctor before use if your child has

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

When using this product, do not exceed recommended dosage

Stop use and ask doctor if

your child gets 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 headache. These could be signs of a serious condition

Indications and Usage

Indications

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

Dosage and Administration

Directions Do not exceed more than 6 doses in any 24-hour period

adults and children 12 years of age and over	take 4 teaspoonfuls (20 mL) every 4 hours
children 6 to under 12 years of age	take 2 teaspoonful (10 mL) every 4 hours
children 2 years to under 6 years of age	take 1 teaspoonful (5 mL) every 4 hours
children under 2 years of age	ask a doctor

Description

Active Ingredients (in each 5 mL tsp.) Purpose Dextromethorphan HBr ............... 5 mg ................ Cough Suppressant Guaifenesin .............................. 75 mg ................ Expectorant Phenylephrine HCl ..................... 2.5 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 right away.

Section 50570-1

Do not usein a child who is 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 child's prescription drug contains an MAOI; ask a doctor or pharmacist before taking this product -Do not use- in a child under 2 years of age.

Section 51727-6

Inactive ingredients citric acid, flavor, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate and sucralose

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

Purpose

Cough Suppressant

Expectorant

Nasal Decongestant

Section 55106-9

Active Ingredients (in each 5 mL tsp.) Purpose

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

Guaifenesin .............................. 75 mg ................ Expectorant

Phenylephrine HCl ..................... 2.5 mg ................... Nasal Decongestant

Structured Label Content

Indications and Usage (34067-9)

Indications

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

Dosage and Administration (34068-7)

Directions Do not exceed more than 6 doses in any 24-hour period

adults and children 12 years of age and over	take 4 teaspoonfuls (20 mL) every 4 hours
children 6 to under 12 years of age	take 2 teaspoonful (10 mL) every 4 hours
children 2 years to under 6 years of age	take 1 teaspoonful (5 mL) every 4 hours
children under 2 years of age	ask a doctor

Warnings and Precautions (34071-1)

Warnings

Ask a doctor before use if your child has

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

When using this product, do not exceed recommended dosage

Stop use and ask doctor if

your child gets 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 headache. These could be signs of a serious condition

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)

Do not usein a child who is 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 child's prescription drug contains an MAOI; ask a doctor or pharmacist before taking this product -Do not use- in a child under 2 years of age.

Section 51727-6 (51727-6)

Inactive ingredients citric acid, flavor, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate and 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 health professional before use.

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 ............... 5 mg ................ Cough Suppressant

Guaifenesin .............................. 75 mg ................ Expectorant

Phenylephrine HCl ..................... 2.5 mg ................... Nasal Decongestant

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"34067-9": "Indications Temporarily relieves cough due to minor throat and bronchial irritation as may occur with common cold helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes temporarily relieves nasal congestion due to the common cold", "34068-7": "Directions Do not exceed more than 6 doses in any 24-hour period adults and children 12 years of age and over take 4 teaspoonfuls (20 mL) every 4 hours children 6 to under 12 years of age take 2 teaspoonful (10 mL) every 4 hours children 2 years to under 6 years of age take 1 teaspoonful (5 mL) every 4 hours children under 2 years of age ask a doctor", "34071-1": "Warnings Ask a doctor before use if your child has heart disease high blood pressure thyroid disease diabetes trouble urinating due to the enlargement of the prostate gland a cough that occurs with too much phlegm (mucus) cough that lasts or is chronic as occurs with smoking, asthma, chronic bronchitis or emphysema When using this product, do not exceed recommended dosage Stop use and ask doctor if your child gets 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 headache. These could be signs of a serious condition", "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": "Do not use in a child who is 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 child's prescription drug contains an MAOI; ask a doctor or pharmacist before taking this product -Do not use- in a child under 2 years of age.", "51727-6": "Inactive ingredients citric acid, flavor, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate and sucralose", "53413-1": "Questions or comments? 1-305-403-3788", "53414-9": "If pregnant or breast-feeding, ask a health professional before use.", "55105-1": "Purpose Cough Suppressant Expectorant Nasal Decongestant", "55106-9": "Active Ingredients (in each 5 mL tsp.) Purpose Dextromethorphan HBr ............... 5 mg ................ Cough Suppressant Guaifenesin .............................. 75 mg ................ Expectorant Phenylephrine HCl ..................... 2.5 mg ................... Nasal Decongestant"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information