Drug Facts

Drug Facts
SPL v8
SPL
SPL Set ID 711d1dae-3af4-46af-a3a8-cd827356a81a
Route
ORAL
Published
Effective Date 2020-02-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dextromethorphan (15 mg)
Inactive Ingredients
Aspartame Honey Potassium Sorbate Propylene Glycol Propylparaben Methylparaben Water Sodium Chloride

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 1997-02-01 Until 2023-05-16
Description

Active Ingredient: (In each teaspoonful 5 mls)                   Purpose Dextromethorphan HBr 15 mg (USP)................................................Cough Suppressant

Medication Information

Warnings and Precautions

Warnings

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

Indications and Usage

Temporarily relieves cough as may occur with the common cold or inhaled irritants.

Dosage and Administration

Directions:

Shake well immediately before use.

Do not exceed 4 doses in any 24 hour period.

Adults and Children 12 years and over - 10 ml (2 tsps) every 6 to 8 hours



Children 6 to under 12 years of age - 5 ml (1 tsp) every 6 to 8 hours



Children under 6 years of age - Consult a doctor

Description

Active Ingredient: (In each teaspoonful 5 mls)                   Purpose Dextromethorphan HBr 15 mg (USP)................................................Cough Suppressant

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

Do not use

  • this product for persistent or chronic cough such as occurs with smoking, asthma, or emphysema, or if cough is accompanied by excessive phlegm (mucus) unless directed by a doctor.
  • if you are now 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 a doctor or pharmacist before taking this product.

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.
Section 51727-6

Inactive Ingredients: Aspartame, Flavor, Honey,

Methylparaben, Potassium Sorbate, Propylene

Glycol, Propylparaben, Purified Water and Sodium

Chloride.

Section 51945-4

Section 53413-1

Questions or Comments?

305.805.3456 Monday-Friday 9AM to 5PM EST

www.efficientlabs.com



Section 53414-9

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

Section 55105-1

Cough Suppressant

Section 55106-9

Active Ingredient: (In each teaspoonful 5 mls)                   Purpose

Dextromethorphan HBr 15 mg (USP)................................................Cough Suppressant

Structured Label Content

Indications and Usage (34067-9)

Temporarily relieves cough as may occur with the common cold or inhaled irritants.

Dosage and Administration (34068-7)

Directions:

Shake well immediately before use.

Do not exceed 4 doses in any 24 hour period.

Adults and Children 12 years and over - 10 ml (2 tsps) every 6 to 8 hours



Children 6 to under 12 years of age - 5 ml (1 tsp) every 6 to 8 hours



Children under 6 years of age - Consult a doctor

Warnings and Precautions (34071-1)

Warnings

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

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)

Do not use

  • this product for persistent or chronic cough such as occurs with smoking, asthma, or emphysema, or if cough is accompanied by excessive phlegm (mucus) unless directed by a doctor.
  • if you are now 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 a doctor or pharmacist before taking this product.

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.
Section 51727-6 (51727-6)

Inactive Ingredients: Aspartame, Flavor, Honey,

Methylparaben, Potassium Sorbate, Propylene

Glycol, Propylparaben, Purified Water and Sodium

Chloride.

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



Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Cough Suppressant

Section 55106-9 (55106-9)

Active Ingredient: (In each teaspoonful 5 mls)                   Purpose

Dextromethorphan HBr 15 mg (USP)................................................Cough Suppressant

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:47.696760 · Updated: 2026-03-14T23:04:04.169402