Drug Facts

Drug Facts
SPL v12
SPL
SPL Set ID 89ea23a5-0da7-407e-83d9-77a0b562f3af
Route
ORAL
Published
Effective Date 2019-12-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Guaifenesin (200 mg)
Inactive Ingredients
Glycerin Sucralose Caulophyllum Thalictroides Root Echinacea, Unspecified Eucalyptus Globulus Leaf Ginkgo Goldenseal Honey Glycyrrhiza Glabra Menthol Methylparaben Verbascum Densiflorum Leaf Myrrh Asclepias Tuberosa Root Potassium Sorbate Propylene Glycol Propylparaben Water Ulmus Rubra Bark Sodium Chloride Prunus Serotina Bark Zinc Sulfate Horehound

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2015-01-01
Description

Active Ingredients: (in each teaspoonful 5 ml.) Purpose Guaifenesin 200 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 bronchial passageways of bothersome mucus.
Dosage and Administration

Directions

  • do not exceed more than 6 doses in any 24 hour period
  • mL=milliliter
  • this adult product is not intended for use in children under 12 years
Age Dose
adults and children 12 years and over 10 mL (2 teaspoonful) every 4 hours
children under 12 years of age do not use
Description

Active Ingredients: (in each teaspoonful 5 ml.) Purpose Guaifenesin 200 mg ................................................................... Expectorant

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

Stop use and ask a doctor if

  • cough persists for more than 1 week, tends to recur, or is accompanied by a fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition.
Section 51727-6

Inactive Ingredients:

Blue Cohosh root extract, Echinacea root extract, Eucalyptus Oil, Ginkgo Biloba leaf extract, glycerin, Golden Seal Root extract,

Honey, Horehound (flower, leaf, stem) extract, Licorice Root extract, Menthol, Methylparaben, Mullein leaf extract, Myrrh gum extract, 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 to 5PM EST) or 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 Ingredients:(in each teaspoonful 5 ml.) Purpose

Guaifenesin 200 mg ................................................................... Expectorant

Section 60561-8

Other information

  • each 10 mL contains: potassium 5 mg
  • store between 15° - 30°C (59° - 86°F). Do not refrigerate
  • product color & flavor may vary due to natural honey

TAMPER - EVIDENT FEATURE: Do not use this product if printed safety seal over cap is torn, broken or missing.

Structured Label Content

Indications and Usage (34067-9)

Uses:

  • Helps loosen phlegm (mucus) and thin bronchial secretions to rid bronchial passageways of bothersome mucus.
Dosage and Administration (34068-7)

Directions

  • do not exceed more than 6 doses in any 24 hour period
  • mL=milliliter
  • this adult product is not intended for use in children under 12 years
Age Dose
adults and children 12 years and over 10 mL (2 teaspoonful) every 4 hours
children under 12 years of age do not use
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 overdose, get medical help or contact a 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 accompanied by a fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition.
Section 51727-6 (51727-6)

Inactive Ingredients:

Blue Cohosh root extract, Echinacea root extract, Eucalyptus Oil, Ginkgo Biloba leaf extract, glycerin, Golden Seal Root extract,

Honey, Horehound (flower, leaf, stem) extract, Licorice Root extract, Menthol, Methylparaben, Mullein leaf extract, Myrrh gum extract, 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 to 5PM EST) or 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 Ingredients:(in each teaspoonful 5 ml.) Purpose

Guaifenesin 200 mg ................................................................... Expectorant

Section 60561-8 (60561-8)

Other information

  • each 10 mL contains: potassium 5 mg
  • store between 15° - 30°C (59° - 86°F). Do not refrigerate
  • product color & flavor may vary due to natural honey

TAMPER - EVIDENT FEATURE: Do not use this product if printed safety seal over cap is torn, broken or missing.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:26.011682 · Updated: 2026-03-14T23:05:09.820545