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

Description

Dextromethorphan HBr 5 mg Guaifenesin 100 mg Phenylephrine HCl 2.5 mg

Purpose

Cough suppressant Expectorant Nasal decongestant


Medication Information

Purpose

Cough suppressant

Expectorant

Nasal decongestant

Description

Dextromethorphan HBr 5 mg Guaifenesin 100 mg Phenylephrine HCl 2.5 mg

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)

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
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.

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

Questions?

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

You may also report side effects to this phone number

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

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

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)

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

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.

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

Questions?

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

You may also report side effects to this phone number

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

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

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