Drug Facts

Drug Facts
SPL v15
SPL
SPL Set ID 31ff48fc-9603-413c-ab7c-2598b3e08f9c
Route
ORAL
Published
Effective Date 2020-02-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Guaifenesin (100 mg)
Inactive Ingredients
Sucralose Caulophyllum Thalictroides Root Citric Acid Monohydrate Echinacea, Unspecified Eucalyptus Oil Ginkgo Glycerin Goldenseal Horehound Glycyrrhiza Glabra Menthol Methylparaben Verbascum Densiflorum Leaf Myrrh Potassium Citrate Potassium Sorbate Propylene Glycol Propylparaben Water Ulmus Rubra Bark Sodium Chloride Zinc Sulfate Prunus Serotina Bark

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 1999-03-01 Until 2023-05-16
Description

Active Ingredient (In each 5ml teaspoonful)................. Purpose Guaifenesin 100 mg ...................................................... Expectorant

Medication Information

Warnings and Precautions

Warnings

Do not exceed recommended dosage.

Ask a doctor before use if you have

  • a persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema or where cough is accompanied by excessive phlegm (mucus)
Indications and Usage



Uses



• Helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome

mucus

Dosage and Administration

Directions:Shake well before use. Do not exceed 6 doses in any 24 hour period or as directed by a doctor

 Age Dose
adults and children 12 years of age and over  10 mL (2tsps) every 4 hours
children 6 to under 12 years of age  5 mL (1 tsp) every 4 hours 
children under 6 years of age  consult a doctor 

Description

Active Ingredient (In each 5ml teaspoonful)................. Purpose Guaifenesin 100 mg ...................................................... Expectorant

Section 50565-1



Keep out of reach of children.

In case of accidental overdose, get medical help or contact the Poison Control Center right away.

Section 50570-1

Stop use and ask a doctor if

• cough persists for more than 1 week, tends to recur, or is accompainied by a fever, rash or persistent headache. A persistent cough may be a sign of serious condition.

Section 51727-6

Inactive Ingredients:

Blue Cohosh root extract, Citric Acid, Echinacea root extract, Eucalyptus Oil, Ginkgo Biloba leaf extract, Glycerin, Golden Seal Root extract, Honey Flavor, Horehound, Licorice Root extract, Menthol, Methylparaben, Mullein Leaf extract, Myrrh gum extract, Potassium Citrate, Potassium Sorbate, Propylene Glycol, Propylparaben, Slippery Elm Bark extract, Sodium Chloride, Sucralose, Water, Wild Cherry Bark extract and Zinc Sulfate.

Section 51945-4

Section 53413-1

Questions or Comments?



305-805-3456 Monday-Friday 9AM-5PM EST

www.efficientlabs.com

Section 53414-9


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

Section 55105-1



Purpose

Expectorant

Section 55106-9



Active Ingredient (In each 5ml teaspoonful)................. Purpose



Guaifenesin 100 mg ...................................................... Expectorant

Structured Label Content

Indications and Usage (34067-9)



Uses



• Helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome

mucus

Dosage and Administration (34068-7)

Directions:Shake well before use. Do not exceed 6 doses in any 24 hour period or as directed by a doctor

 Age Dose
adults and children 12 years of age and over  10 mL (2tsps) every 4 hours
children 6 to under 12 years of age  5 mL (1 tsp) every 4 hours 
children under 6 years of age  consult a doctor 

Warnings and Precautions (34071-1)

Warnings

Do not exceed recommended dosage.

Ask a doctor before use if you have

  • a persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema or where cough is accompanied by excessive phlegm (mucus)
Section 50565-1 (50565-1)



Keep out of reach of children.

In case of accidental overdose, get medical help or contact the Poison Control Center right away.

Section 50570-1 (50570-1)

Stop use and ask a doctor if

• cough persists for more than 1 week, tends to recur, or is accompainied by a fever, rash or persistent headache. A persistent cough may be a sign of serious condition.

Section 51727-6 (51727-6)

Inactive Ingredients:

Blue Cohosh root extract, Citric Acid, Echinacea root extract, Eucalyptus Oil, Ginkgo Biloba leaf extract, Glycerin, Golden Seal Root extract, Honey Flavor, Horehound, Licorice Root extract, Menthol, Methylparaben, Mullein Leaf extract, Myrrh gum extract, Potassium Citrate, Potassium Sorbate, Propylene Glycol, Propylparaben, Slippery Elm Bark extract, Sodium Chloride, Sucralose, Water, Wild Cherry Bark extract and Zinc Sulfate.

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions or Comments?



305-805-3456 Monday-Friday 9AM-5PM EST

www.efficientlabs.com

Section 53414-9 (53414-9)


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

Section 55105-1 (55105-1)



Purpose

Expectorant

Section 55106-9 (55106-9)



Active Ingredient (In each 5ml teaspoonful)................. Purpose



Guaifenesin 100 mg ...................................................... Expectorant

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:47.677845 · Updated: 2026-03-14T23:13:02.501548