Mucosan Severe Multi-symptom

Mucosan Severe Multi-symptom
SPL v2
SPL
SPL Set ID 26a69342-f65f-cb46-e063-6394a90ade10
Route
ORAL
Published
Effective Date 2024-11-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Phenylephrine (10 mg) Dextromethorphan (20 mg) Guaifenesin (400 mg)
Inactive Ingredients
Fd&c Blue No. 1 Glycerin Edetate Disodium Propyl Gallate Propylene Glycol Sodium Benzoate Anhydrous Citric Acid Sorbitol Fd&c Red No. 40 Sucralose Xanthan Gum Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-11-01
Description

Active ingredients (in each 20 mL) Purpose Dextromethorphan HBr, 20 mg...........................Cough suppressant Guaifenesin, 400 mg..........................................Expectorant Phenylephrine HCl, 10 mg.................................Nasal decongestant

Medication Information

Warnings and Precautions

Do not useif you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional condition, 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.

Indications and Usage

Uses

  • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes
  • temporarily relieves these symptoms occuring with a cold:
  • nasal congestion
  • cough due to minor throat and bronquial irritation.
Dosage and Administration

Directions

  • do not take more than 6 doses in any 24 hour period
  • this adult strenght product is not intended for use in children under 12 years of age
  • measure only wih doisng cup provided
  • keep dosing cup with product
  • mL=milliliter

age dose
adults and children 12 years of age and older 20 mL every 4 hours
children under 1 years of age do not use

Description

Active ingredients (in each 20 mL) Purpose Dextromethorphan HBr, 20 mg...........................Cough suppressant Guaifenesin, 400 mg..........................................Expectorant Phenylephrine HCl, 10 mg.................................Nasal decongestant

Section 34088-5

Do not exceed recommended dosage.

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 50566-9

Stop use and ask a doctor if

  • you get nervous, dizzy or sleepless
  • symptoms do not get better within 7 days or are accompanied by fever
  • cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistant headache. These could be signs of a serious condition.
Section 50568-5

Ask a doctor or pharmacist before use if you aretaking any other oral nasal decongestant or stimulant.

Section 50569-3

Ask a doctor before use if you have

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland
  • cough that occurs with too much phlegm (mucus)
  • cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema.
Section 51727-6

Inactive ingredients

anhydrous citric acid, edetate disodium, FD&C blue #1, FD&C red #40, flavors, glycerin, propylene glycol, propyl gallate, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum.

Section 51945-4

Section 53413-1

Questions or comments?

1-800-560-5223Monday to Friday 9am-4pm, Eastern Time

Section 53414-9

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

Section 55105-1

Purposes

Cough suppressant

Expectorant

Nasal descongestant

Section 55106-9

Active ingredients (in each 20 mL) Purpose

Dextromethorphan HBr, 20 mg...........................Cough suppressant

Guaifenesin, 400 mg..........................................Expectorant

Phenylephrine HCl, 10 mg.................................Nasal decongestant

Section 60561-8

Other information

  • each (20mL) dose contains:sodium 10 mg
  • store between 15-30°C (59-86°F)
  • do not refrigerate.

Structured Label Content

Indications and Usage (34067-9)

Uses

  • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes
  • temporarily relieves these symptoms occuring with a cold:
  • nasal congestion
  • cough due to minor throat and bronquial irritation.
Dosage and Administration (34068-7)

Directions

  • do not take more than 6 doses in any 24 hour period
  • this adult strenght product is not intended for use in children under 12 years of age
  • measure only wih doisng cup provided
  • keep dosing cup with product
  • mL=milliliter

age dose
adults and children 12 years of age and older 20 mL every 4 hours
children under 1 years of age do not use

Warnings and Precautions (34071-1)

Do not useif you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional condition, 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.

Section 34088-5 (34088-5)

Do not exceed recommended dosage.

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 50566-9 (50566-9)

Stop use and ask a doctor if

  • you get nervous, dizzy or sleepless
  • symptoms do not get better within 7 days or are accompanied by fever
  • cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistant headache. These could be signs of a serious condition.
Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you aretaking any other oral nasal decongestant or stimulant.

Section 50569-3 (50569-3)

Ask a doctor before use if you have

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland
  • cough that occurs with too much phlegm (mucus)
  • cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema.
Section 51727-6 (51727-6)

Inactive ingredients

anhydrous citric acid, edetate disodium, FD&C blue #1, FD&C red #40, flavors, glycerin, propylene glycol, propyl gallate, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum.

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions or comments?

1-800-560-5223Monday to Friday 9am-4pm, Eastern Time

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Purposes

Cough suppressant

Expectorant

Nasal descongestant

Section 55106-9 (55106-9)

Active ingredients (in each 20 mL) Purpose

Dextromethorphan HBr, 20 mg...........................Cough suppressant

Guaifenesin, 400 mg..........................................Expectorant

Phenylephrine HCl, 10 mg.................................Nasal decongestant

Section 60561-8 (60561-8)

Other information

  • each (20mL) dose contains:sodium 10 mg
  • store between 15-30°C (59-86°F)
  • do not refrigerate.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:08:08.972984 · Updated: 2026-03-14T23:12:18.638181