childrens multi-symptom cold relief

childrens multi-symptom cold relief
SPL v2
SPL
SPL Set ID 3d09bfea-7f73-45ab-bb62-50e9bae90367
Route
oral
Published
Effective Date 2019-12-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
dextromethorphan (5 mg) guaifenesin (100 mg) phenylephrine (2.5 mg)
Inactive Ingredients
anhydrous citric acid d&c red no. 33 dextrose edetate disodium fd&c blue no. 1 fd&c red no. 40 glycerin methylparaben potassium sorbate propyl gallate propylene glycol propylparaben saccharin sodium water sodium hydroxide sorbitol sucralose xanthan gum

Identifiers & Packaging

Marketing Status
otc monograph final active Since 2014-12-12

Purpose

Cough suppressant Expectorant Nasal decongestant

Description

Dextromethorphan HBr 5 mg Guaifenesin 100 mg Phenylephrine HCl 2.5 mg


Medication Information

Warnings

Do not use in 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 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.

Uses
  • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive
  • temporarily relieves:
  • cough due to minor throat and bronchial irritation as may occur with a cold or inhaled irritants
  • the intensity of coughing
  • the impulse to cough to help your child get to sleep
  • nasal congestion due to a cold
  • stuffy nose
Purpose

Cough suppressant

Expectorant

Nasal decongestant

Directions
  • do not take more than 6 doses in any 24 hour period
  • measure only with dosing cup provided
  • do not use dosing cup with other products
  • dose as follows or as directed by a doctor

 Age Dose 
 children 6 years to under 12 years  10 mL every 4 hours
 children 4 years to under 6 years  5 mL every 4 hours
 children under 4 years  do not use

Other Information
  • each 5 mL contains: potassium 5 mg, sodium 5 mg
  • store between 15-30oC (59-86oF)
  • do not refrigerate
  • dosing cup provided
Inactive Ingredients

citric acid anhydrous, D&C red 33, dextrose, edetate disodium, FD&C blue 1, FD&C red 40, flavor, glycerin, methylparaben, potassium sorbate, propyl gallate, propylene glycol, propylparaben, purified water, saccharin sodium, sodium hydroxide, sorbitol solution, sucralose, xanthan gum

Description

Dextromethorphan HBr 5 mg Guaifenesin 100 mg Phenylephrine HCl 2.5 mg

Questions?

1-800-824-1706 Monday - Friday 9am-4pm MST.

You may also report side effects to this phone number

Pdp

*Compare to the active ingredients in Children's MUCINEX® Multi-symptom cold

Children's Multi-symptom Cold Relief

Dextromethorphan HBr / Cough suppressant

Guaifenesin / Expectorant

Phenylephrine HCl / Nasal decongestant

Relieves:Stuffy Nose, Cough, Chest Congestion

Thins and Loosens Mucus

For Ages 4-12 Years

Ver Berry Flavor

4 FL OZ (118 mL)

When Using This Product
  • do not use more than directed
Stop Use and Ask A Doctor If
  • your child gets nervous, dizzy or sleepless
  • symptoms do not get better within 7 days or occur with fever
  • cough lasts more than 7 days, comes back, or occurs with fever, rash or persistent headache. These could be signs of a serious illness.

keep out of reach of children. In case of overdose, get medical help or contact a poison control center right away.

Active Ingredients (in Each 5 Ml)

Dextromethorphan HBr 5 mg

Guaifenesin 100 mg

Phenylephrine HCl 2.5 mg

Ask A Doctor Before Use If the Child Has
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • persistent or chronic cough such as occurs with asthma
  • cough that occurs with too much phlegm (mucus)

Structured Label Content

Warnings

Do not use in 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 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.

Uses
  • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive
  • temporarily relieves:
  • cough due to minor throat and bronchial irritation as may occur with a cold or inhaled irritants
  • the intensity of coughing
  • the impulse to cough to help your child get to sleep
  • nasal congestion due to a cold
  • stuffy nose
Purpose

Cough suppressant

Expectorant

Nasal decongestant

Directions
  • do not take more than 6 doses in any 24 hour period
  • measure only with dosing cup provided
  • do not use dosing cup with other products
  • dose as follows or as directed by a doctor

 Age Dose 
 children 6 years to under 12 years  10 mL every 4 hours
 children 4 years to under 6 years  5 mL every 4 hours
 children under 4 years  do not use

Other Information (Other information)
  • each 5 mL contains: potassium 5 mg, sodium 5 mg
  • store between 15-30oC (59-86oF)
  • do not refrigerate
  • dosing cup provided
Inactive Ingredients (Inactive ingredients)

citric acid anhydrous, D&C red 33, dextrose, edetate disodium, FD&C blue 1, FD&C red 40, flavor, glycerin, methylparaben, potassium sorbate, propyl gallate, propylene glycol, propylparaben, purified water, saccharin sodium, sodium hydroxide, sorbitol solution, sucralose, xanthan gum

Questions?

1-800-824-1706 Monday - Friday 9am-4pm MST.

You may also report side effects to this phone number

Pdp (PDP)

*Compare to the active ingredients in Children's MUCINEX® Multi-symptom cold

Children's Multi-symptom Cold Relief

Dextromethorphan HBr / Cough suppressant

Guaifenesin / Expectorant

Phenylephrine HCl / Nasal decongestant

Relieves:Stuffy Nose, Cough, Chest Congestion

Thins and Loosens Mucus

For Ages 4-12 Years

Ver Berry Flavor

4 FL OZ (118 mL)

When Using This Product (When using this product)
  • do not use more than directed
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • your child gets nervous, dizzy or sleepless
  • symptoms do not get better within 7 days or occur with fever
  • cough lasts more than 7 days, comes back, or occurs with fever, rash or persistent headache. These could be signs of a serious illness.

keep out of reach of children. In case of overdose, get medical help or contact a poison control center right away.

Active Ingredients (in Each 5 Ml) (Active ingredients (in each 5 mL))

Dextromethorphan HBr 5 mg

Guaifenesin 100 mg

Phenylephrine HCl 2.5 mg

Ask A Doctor Before Use If the Child Has (Ask a doctor before use if the child has)
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • persistent or chronic cough such as occurs with asthma
  • cough that occurs with too much phlegm (mucus)

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)