Kinray, LLC Children’s Mucus Relief Multi-Symptom Cold Drug Facts

preferred plus childrens mucus relief multi symptom cold by

Drug Labeling and Warnings

preferred plus childrens mucus relief multi symptom cold by is a Otc medication manufactured, distributed, or labeled by Kinray. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PREFERRED PLUS CHILDRENS MUCUS RELIEF MULTI SYMPTOM COLD- dextromethorphan hbr, guaifenesin, phenylephrine hcl solution 
Kinray

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.

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Kinray, LLC Children’s Mucus Relief Multi-Symptom Cold Drug Facts

Active ingredients (in each 5 mL)

Dextromethorphan HBr 5 mg

Guaifenesin 100 mg

Phenylephrine HCl 2.5 mg

Purposes

Cough suppressant

Expectorant

Nasal decongestant

Uses

  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
  • temporarily relieves:
  • cough due to minor throat and bronchial irritation as may occur with the common 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 child’s 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
  • cough that occurs with too much phlegm (mucus)
  • persistent or chronic cough such as occurs with asthma

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 condition.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

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
  • mL = milliliter

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: sodium 3 mg
  • do not use if printed neckband is broken or missing
  • store at 20-25°C (68-77°F)
  • do not refrigerate
  • dosing cup provided

Inactive ingredients

anhydrous citric acid, edetate disodium, FD&C red #40, flavor, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose, xanthan gum

Questions or comments?

1-800-719-9260

Package/Label Principal Display Panel

Compare to the active ingredients in Children’s Mucinex® Multi-Symptom Cold

Children’s

Mucus Relief Multi-Symptom Cold

Guaifenesin 100 mg – Expectorant

Dextromethorphan HBr 5 mg – Cough Suppressant

Phenylephrine HCl 2.5 mg – Nasal Decongestant

Stuffy Nose

Cough

Chest Congestion

Breaks Up Mucus

Very Berry Flavor Liquid

Age 4+

4 FL OZ (118 mL)

Preferred Plus Children's Mucus Relief Multi-Symptom Cold image 1
Preferred Plus Children's Mucus Relief Multi-Symptom Cold image 2
PREFERRED PLUS CHILDRENS MUCUS RELIEF MULTI SYMPTOM COLD 
dextromethorphan hbr, guaifenesin, phenylephrine hcl solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 61715-138
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE5 mg  in 5 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN100 mg  in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE2.5 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
SORBITOL (UNII: 506T60A25R)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Product Characteristics
ColorRED (clear) Score    
ShapeSize
FlavorBERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 61715-138-041 in 1 CARTON07/01/201509/14/2018
1118 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34105/08/201509/14/2018
Labeler - Kinray (012574513)

Revised: 11/2019
 
Kinray