Drug Facts

Drug Facts
SPL v26
SPL
SPL Set ID 96c4dee1-6e66-4442-a7e3-56e874414c17
Route
ORAL
Published
Effective Date 2019-12-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dextromethorphan (10 mg) Guaifenesin (100 mg) Phenylephrine (5 mg)
Inactive Ingredients
Horehound Sucralose Caulophyllum Thalictroides Root Echinacea, Unspecified Eucalyptus Globulus Leaf Ginkgo Goldenseal Honey Glycyrrhiza Glabra Menthol Methylparaben Verbascum Densiflorum Leaf Myrrh Potassium Sorbate Propylene Glycol Propylparaben Water Ulmus Rubra Bark Sodium Chloride Prunus Serotina Bark Zinc Sulfate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 2007-10-01 Until 2027-03-31
Description

Active Ingredients: (in each teaspoonful 5 ml.)                                Purpose Dextromethorphan HBr 10 mg ...................................... Cough Suppressant Guaifenesin 100 mg ................................................................... Expectorant Phenylephrine HCL  5 mg .................................................... Nasal Decongestant

Medication Information

Warnings and Precautions

Warnings

Do not exceed recommended dosage.

Do not use

  • If you are 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 your doctor or pharmacist before taking this product.

Indications and Usage

Uses

  • temporarily relieves cough and nasal congestion as may occur with the common cold
  • 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 more than 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 (2 tsps) 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 Ingredients: (in each teaspoonful 5 ml.)                                Purpose Dextromethorphan HBr 10 mg ...................................... Cough Suppressant Guaifenesin 100 mg ................................................................... Expectorant Phenylephrine HCL  5 mg .................................................... Nasal Decongestant

Section 50565-1

Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away.

Section 50570-1





Ask a doctor before use if you have

• heart disease

• high blood pressure

• thyroid disease

• diabetes

• trouble urinating due to an enlarged prostate gland

• a persistant or chronic cough

  • a cough that is accompanied by excessive phlegm (mucus)

• a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema.



Stop use and ask doctor if

  • symptoms do not improve within 7 days or is accompanied by a fever, rash, or persistent headache. A persistent cough may be sign of a serious condition.
  • nervousness, dizziness, or sleeplessness occurs
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, 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

www.efficientlabs.com



Distributed by

Efficient Laboratories, Inc., Miami, Fl 33166

Made in U.S.A.

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 teaspoonful 5 ml.)                                Purpose

Dextromethorphan HBr 10 mg ...................................... Cough Suppressant

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

Phenylephrine HCL  5 mg .................................................... Nasal Decongestant

Structured Label Content

Indications and Usage (34067-9)

Uses

  • temporarily relieves cough and nasal congestion as may occur with the common cold
  • 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 more than 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 (2 tsps) 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.

Do not use

  • If you are 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 your doctor or pharmacist before taking this product.

Section 50565-1 (50565-1)

Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away.

Section 50570-1 (50570-1)





Ask a doctor before use if you have

• heart disease

• high blood pressure

• thyroid disease

• diabetes

• trouble urinating due to an enlarged prostate gland

• a persistant or chronic cough

  • a cough that is accompanied by excessive phlegm (mucus)

• a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema.



Stop use and ask doctor if

  • symptoms do not improve within 7 days or is accompanied by a fever, rash, or persistent headache. A persistent cough may be sign of a serious condition.
  • nervousness, dizziness, or sleeplessness occurs
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, 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

www.efficientlabs.com



Distributed by

Efficient Laboratories, Inc., Miami, Fl 33166

Made in U.S.A.

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 teaspoonful 5 ml.)                                Purpose

Dextromethorphan HBr 10 mg ...................................... Cough Suppressant

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

Phenylephrine HCL  5 mg .................................................... Nasal Decongestant

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:58.382977 · Updated: 2026-03-14T23:10:05.459246