Mucosan Childrens Multi-symptom Grape

Mucosan Childrens Multi-symptom Grape
SPL v2
SPL
SPL Set ID 266c8cce-cdf9-557d-e063-6394a90a9bc3
Route
ORAL
Published
Effective Date 2024-11-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Guaifenesin (50 mg) Dextromethorphan (5 mg) Phenylephrine (2.5 mg)
Inactive Ingredients
Citric Acid Xanthan Gum Sodium Benzoate Fd&c Red No. 40 Water Fd&c Blue No. 1 Glycerin Sorbitol Sucralose Propylene Glycol

Identifiers & Packaging

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

Active ingredients (in each 5 mL, 1 teaspoon) Purposes Dextromethorphan HBr, 5 mg...............................Cough suppressant Guaifenesin, 50 mg...............................................Expectorant Phenylephrine HCl, 2.5 mg...................................Nasal decongestant

Medication Information

Warnings and Precautions

Do not usein a child who is taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 week after stopping the MAOI drug. If you do not know if your child's prescritpion 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 occurring with a cold:
  • nasal congestion
  • cough due to minor throat and bronchial irritation
Dosage and Administration

Directions

  • do not take more than 6 doses in any 24 hour period
  • measure only with dosing cup provided
  • keep dosing cup with product
  • TSP=teaspoon

age dose
children 6 to under 12 years 2 teaspoons (10mL) every 4 hours
children 4 to under 6 years 1 teaspoon (5mL) every 4 hours
children under 4 years do not use

Description

Active ingredients (in each 5 mL, 1 teaspoon) Purposes Dextromethorphan HBr, 5 mg...............................Cough suppressant Guaifenesin, 50 mg...............................................Expectorant Phenylephrine HCl, 2.5 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 (1-800-222-1222) immediately.

Section 50566-9

Stop use and ask a doctor if

  • nervousness, dizziness, or sleeplessness occurs
  • 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 persistent headache.

These could be signs of a serious condition.

Section 50568-5

Ask a doctor or pharmacist before use if the child istaking any other oral nasal decongestant or stimulant.

Section 50569-3

Ask a doctor before use if the child has

  • heart disease
  • diabetes
  • high blood pressure
  • thyroid disease
  • cough that lasts or is chronic such as occurs with asthma
  • cough that occurs with too much phlegm (mucus)
Section 51727-6

Inactive ingredients

citric acid, FD&C blue #1, FD&C red #40, flavor, glycerin, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum.

Section 51945-4

Section 53413-1

Questions or comments?

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

Section 55105-1

Purpose

Cough suppressant

Expectorant

Nasal decongestant

Section 55106-9

Active ingredients (in each 5 mL, 1 teaspoon) Purposes

Dextromethorphan HBr, 5 mg...............................Cough suppressant

Guaifenesin, 50 mg...............................................Expectorant

Phenylephrine HCl, 2.5 mg...................................Nasal decongestant

Section 60561-8

Other information

  • each teaspoon (5mL) contains:sodium 3 mg
  • store at 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 occurring with a cold:
  • nasal congestion
  • cough due to minor throat and bronchial irritation
Dosage and Administration (34068-7)

Directions

  • do not take more than 6 doses in any 24 hour period
  • measure only with dosing cup provided
  • keep dosing cup with product
  • TSP=teaspoon

age dose
children 6 to under 12 years 2 teaspoons (10mL) every 4 hours
children 4 to under 6 years 1 teaspoon (5mL) every 4 hours
children under 4 years do not use

Warnings and Precautions (34071-1)

Do not usein a child who is taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 week after stopping the MAOI drug. If you do not know if your child's prescritpion 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 (1-800-222-1222) immediately.

Section 50566-9 (50566-9)

Stop use and ask a doctor if

  • nervousness, dizziness, or sleeplessness occurs
  • 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 persistent headache.

These could be signs of a serious condition.

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if the child istaking any other oral nasal decongestant or stimulant.

Section 50569-3 (50569-3)

Ask a doctor before use if the child has

  • heart disease
  • diabetes
  • high blood pressure
  • thyroid disease
  • cough that lasts or is chronic such as occurs with asthma
  • cough that occurs with too much phlegm (mucus)
Section 51727-6 (51727-6)

Inactive ingredients

citric acid, FD&C blue #1, FD&C red #40, flavor, glycerin, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum.

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions or comments?

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

Section 55105-1 (55105-1)

Purpose

Cough suppressant

Expectorant

Nasal decongestant

Section 55106-9 (55106-9)

Active ingredients (in each 5 mL, 1 teaspoon) Purposes

Dextromethorphan HBr, 5 mg...............................Cough suppressant

Guaifenesin, 50 mg...............................................Expectorant

Phenylephrine HCl, 2.5 mg...................................Nasal decongestant

Section 60561-8 (60561-8)

Other information

  • each teaspoon (5mL) contains:sodium 3 mg
  • store at 15-30°C (59-86°F). Do not refrigerate.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:08:08.967491 · Updated: 2026-03-14T23:12:18.638181