Mucosan Multi-symptom Honey

Mucosan Multi-symptom Honey
SPL v2
SPL
SPL Set ID 2669c620-ab70-abaa-e063-6394a90a58e7
Route
ORAL
Published
Effective Date 2024-11-08
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
Anhydrous Citric Acid Fd&c Yellow No. 6 Sucralose Sodium Benzoate Honey Water Xanthan Gum Glycerin Propylene Glycol Sorbitol Solution

Identifiers & Packaging

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

Description

Active ingredients (in each 5 mL or 1 teaspoon) Purposes Dextromethorphan HBr, 10 mg............................Cough suppressant Guaifenesin, 100 mg...........................................Expectorant Phenylephrine HCl, 5 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, psychiatrixm or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescroption 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
  • this adul strength product is not intended for use in children under 12 years of age
  • measure only with dosing cup provided
  • keep dosing cup with product
  • TSP = teaspoon

age dose
adults and children 12 years and over 2 teaspoons (10mL) every 4 hours
children undre 12 years do not use

Description

Active ingredients (in each 5 mL or 1 teaspoon) Purposes Dextromethorphan HBr, 10 mg............................Cough suppressant Guaifenesin, 100 mg...........................................Expectorant Phenylephrine HCl, 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 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 (musus)
  • cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema
Section 51727-6

anhydrous citric acid, FD&C yellow #6, flavor, glycerin, honey, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose, xanthan gum

Section 51945-4

Section 53413-1

Questions or comments?

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

Section 53414-9

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

Section 55105-1

Purposes

Cough suppressant

Expectorant

Nasal decongestant

Section 55106-9

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

Dextromethorphan HBr, 10 mg............................Cough suppressant

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

Phenylephrine HCl, 5 mg....................................Nasal decongestant

Section 60561-8

Other information

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

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
  • this adul strength product is not intended for use in children under 12 years of age
  • measure only with dosing cup provided
  • keep dosing cup with product
  • TSP = teaspoon

age dose
adults and children 12 years and over 2 teaspoons (10mL) every 4 hours
children undre 12 years 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, psychiatrixm or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescroption 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 (musus)
  • cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema
Section 51727-6 (51727-6)

anhydrous citric acid, FD&C yellow #6, flavor, glycerin, honey, propylene glycol, purified water, sodium benzoate, sorbitol solution, 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 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Purposes

Cough suppressant

Expectorant

Nasal decongestant

Section 55106-9 (55106-9)

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

Dextromethorphan HBr, 10 mg............................Cough suppressant

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

Phenylephrine HCl, 5 mg....................................Nasal decongestant

Section 60561-8 (60561-8)

Other information

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

Advanced Ingredient Data


Raw Label Data

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