Label: CHILDRENS MULTI-SYMPTOM COLD- guaifenesin, dextromethorphan hydrobromide, phenylephrine hydrochloride liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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.

Drug Label Information

Updated February 28, 2013

If you are a consumer or patient please visit this version.

  • Active ingredients

    Drug Facts

    Active ingredients

    (in each 5 mL teaspoon)

    Guaifenesin 100 mg
    Dextromethorphan HBr 5 mg
    Phenylephrine HCL 2.5 mg

  • Purpose

    Purpose

     Cough suppressant
     Expectorant
     Nasal decongestant

  • Keep out of reach of children

    Keep out of reach of children.

    In case of overdose, get medical help or contact a Poison Control center right away.

  • Uses

    Uses

    • helps to loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passage ways of bothersome mucus and make coughs more productive
    • temporarily relieves these symptoms occurring with a cold:
    • cough due to minor throat and bronchial irritation
    • nasal congestion
    • stuffy nose
  • Warnings

    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 two weeks after stopping the MAOI drug. If you do not know if your child’s prescription drug contains an MAOI, ask a doctor or a pharmacist before taking this product.

  • Ask a doctor before use

    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


    When using this product

    • do not use more than directed
  • Stop use and ask a doctor

    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.

  • Directions

    Directions

    • do not take more than 6 doses in any 24-hour period

    Age                                                                                             Dose
    Children 6 years to under 12 years                                                 2 teaspoons every 4 hours
    Children 4 years to under 6 years                                                   1 teaspoon every 4 hours
    Children under 4 years                                                                  Do not use

  • Other information

    Other information

    • each 5 mL teaspoon contains: sodium 3 mg
    • store between 15-30 ° C (59-86° F)
    • do not refrigerate
    • dosing cup provided
  • Inactive ingredients

    Inactive ingredients
    citric acid anhydrous, D and C red #33,dextrose, FD and C blue #1, FD and C red # 40, flavors, glycerin, maltitol, propylene glycol, purified water, saccharin sodium, sodium benzoate, sucralose, xanthan gum

  • Questions?

    Questions?

    Call weekdays from 9:30 AM to 4:30 PM EST at

    1-877-798-5944

  • Product Label

    NDC 68016-134-00

    *COMPARE TO THE ACTIVE INGREDIENTS IN CHILDREN’S MUCINEX®Multisymptom Cold

    Premier Value®
    CHILDREN’S MULTI- SYMPTOM COLD

    EXPECTORANT
    COUGH SUPPRESSANT
    NASAL DECONGESTANT

    Guaifenesin 100 mg
    Dextromethorphan HBr 5 mg
    Phenylephrine HCL 2.5 mg

    * Stuffy Nose
    * Cough
    * Chest Congestion
    * Breaks up Mucus

    Alcohol free

    For ages 4 to 12

    Very Berry Flavor
    4 FL OZ (118mL)

    INDEPENDENTLY TESTED SATISFACTION GUARANTEED PV
    DO NOT USE IF PRINTED SEAL UNDER CAP IS TORN OR MISSING

    *This product is not manufactured or distributed by Reckitt Benckiser Inc. distributor of Children’s Mucinex® Multisymptom Cold
    If for Any reason you are not satisfied with this product, lease return it to the store where purchased for a full refund.
    DISTRIBUTED BY
    CHAIN DRUG CONSORTIUM
    3301 NW BOCA RATON BLVD
    SUITE 101, BOCA RATON, FL 33431
    BX-010

    AptaPharma hildrens MSCold Label

  • INGREDIENTS AND APPEARANCE
    CHILDRENS MULTI-SYMPTOM COLD 
    guaifenesin, dextromethorphan hydrobromide, phenylephrine hydrochloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-134
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN100 mg  in 5 mL
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE5 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)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    DEXTROSE (UNII: IY9XDZ35W2)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MALTITOL (UNII: D65DG142WK)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorBERRY (VERY BERRY) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68016-134-00118 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34109/27/2012
    Labeler - Chain Drug Consortium, LLC (101668460)
    Registrant - AptaPharma Inc. (790523323)
    Establishment
    NameAddressID/FEIBusiness Operations
    AptaPharma Inc.790523323manufacture(68016-134)