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Childrens Tussnex Multi-symptom cold

Medically reviewed on Jun 4, 2018

Dosage form: liquid
Ingredients: DEXTROMETHORPHAN HYDROBROMIDE 5mg in 5mL, GUAIFENESIN 100mg in 5mL, PHENYLEPHRINE HYDROCHLORIDE 2.5mg in 5mL
Labeler: Guardian Drug Company
NDC Code: 53041-615

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Childrens Tussnex Multi-symptom cold

Active ingredients (in each 5 mL)

Dextromethorphan HBr 5 mg

Guaifenesin 100 mg

Phenylephrine HCl 2.5 mg

Purpose

Cough suppressant

Expectorant

Nasal decongestant

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.

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)

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.

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

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

PDP

compare to active ingredients in Mucinex children's Multi-symptom cold

Children's Tussnex Multi-symptom cold

Dextromethorphan HBr

Cough suppressant

Guaifenesin

Expectorant

Phenylephrine HCl

Nasal decongestant

Relieves nasal and chest chest congestion

Thins and loosens mucus

Soothes cough

Alcohol free

CHILDRENS TUSSNEX MULTI-SYMPTOM COLD 
dextromethorphan hbr, guaifenesin, phenylephrine hcl liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53041-615
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE5 mg  in 5 mL
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN100 mg  in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE2.5 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
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 
Product Characteristics
ColorredScore    
ShapeSize
FlavorBERRYImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:53041-615-031 BOTTLE in 1 CARTON
1118 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34112/01/2012
Labeler - Guardian Drug Company (119210276)

 
Guardian Drug Company

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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