Drug Facts

Composition & Product

Active Ingredients

Ephedrine (25 mg) Guaifenesin (400 mg)

Inactive Ingredients

Water Fd&c Blue No. 1 Fd&c Red No. 40 Potassium Sorbate Sodium Benzoate Sucralose Citric Acid Monohydrate Malic Acid Propylene Glycol

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH FINAL Active Since 2017-11-10

Medication Information

Warnings and Precautions

Warnings

Indications and Usage

Uses for temporary relief of mild symptoms of intermittent asthma: wheezing

tightness of chest , shortness of breath , helps loosen phlegm (mucus) and thin

bronchial secretions to rid bronchial passageways of bothersome mucus, and to make

coughs more productive

Dosage and Administration

Directions do not take more than directed

adults and children 12 years of age and over: take 1

bottle every 4 hours as needed. Do not take more than

6 bottles in 24 hours children under 12 years of age:

do not use

Description

Warnings

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 51727-6

Inactive ingredients Blue #1, Citric Acid,

Filtered Water, Malic Acid, Natural and Artificial Flavors,

Potassium Sorbate, Propylene Glycol, Sodium

Section 51945-4

Section 53414-9

If pregnant or breast-feeding, ask a health

professional before use

Section 55105-1

Purpose: Bronchodilator, Expectorant

Section 55106-9

Ephedrine HCI 25 mg, Bronchodilator

Guaifenesin 400 mg, Expectorant

Structured Label Content

Indications and Usage (34067-9)

Uses for temporary relief of mild symptoms of intermittent asthma: wheezing

tightness of chest , shortness of breath , helps loosen phlegm (mucus) and thin

bronchial secretions to rid bronchial passageways of bothersome mucus, and to make

coughs more productive

Dosage and Administration (34068-7)

Directions do not take more than directed

adults and children 12 years of age and over: take 1

bottle every 4 hours as needed. Do not take more than

6 bottles in 24 hours children under 12 years of age:

do not use

Warnings and Precautions (34071-1)

Warnings

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 51727-6 (51727-6)

Inactive ingredients Blue #1, Citric Acid,

Filtered Water, Malic Acid, Natural and Artificial Flavors,

Potassium Sorbate, Propylene Glycol, Sodium

Section 51945-4 (51945-4)

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health

professional before use

Section 55105-1 (55105-1)

Purpose: Bronchodilator, Expectorant

Section 55106-9 (55106-9)

Ephedrine HCI 25 mg, Bronchodilator

Guaifenesin 400 mg, Expectorant

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"34067-9": "Uses for temporary relief of mild symptoms of intermittent asthma: wheezing tightness of chest , shortness of breath , helps loosen phlegm (mucus) and thin bronchial secretions to rid bronchial passageways of bothersome mucus, and to make coughs more productive", "34068-7": "Directions do not take more than directed adults and children 12 years of age and over: take 1 bottle every 4 hours as needed. Do not take more than 6 bottles in 24 hours children under 12 years of age: do not use", "34071-1": "Warnings", "50565-1": "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.", "51727-6": "Inactive ingredients Blue #1, Citric Acid, Filtered Water, Malic Acid, Natural and Artificial Flavors, Potassium Sorbate, Propylene Glycol, Sodium", "53414-9": "If pregnant or breast-feeding, ask a health professional before use", "55105-1": "Purpose: Bronchodilator, Expectorant", "55106-9": "Ephedrine HCI 25 mg, Bronchodilator Guaifenesin 400 mg, Expectorant"}

Drug Facts

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information