Label: CHILDRENS COLD, COUGH AND SORE THROAT- acetaminophen, guaifenesin, dextromethorphan hbr, phenylephrine hcl liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 April 12, 2013

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

  • Active ingredients

    Drug Facts

    Active ingredients

    (in each 10 mL or 2 teaspoons)

    Acetaminophen 325 mg
    Dextromethorphan HBr 10 mg
    Guaifenesin 200 mg
    Phenylephrine HCL 5 mg

  • Purpose

    Purpose

    Pain reliever/fever reducer
    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

    • temporarily relieves these common cold and flu symptoms:
    • nasal congestion
    • minor aches and pains
    • headache
    • stuffy nose
    • sore throat
    • fever
    • cough due to minor throat and bronchial irritation
    • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes
  • Warnings

    Liver warning: This product contains acetaminophen. Sever liver damage may occur if your child if your child takes

    • more than 5 doses in 24 hours, which is the maximum daily amount
    • with other drugs containing acetaminophen


    Sore throat warning: if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea or vomiting, consult a doctor promptly.

  • Do not use

    • with any other drugs containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
    • 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 if your child has



    • liver disease
    • high blood pressure
    • diabetes
    • heart disease
    • thyroid disease
    • a breathing problem such as chronic bronchitis
    • persistent or chronic cough such as occurs with asthma
    • cough that occurs with too much phlegm (mucus)
  • Ask a doctor or pharmacist before use if

    • your child is taking the blood  thinning drug warfarin
  • Stop use and ask a doctor if

    • redness or swelling is present
    • nervousness, dizziness or sleeplessness occur
    • new symptoms occur
    • pain, nasal congestion or cough gets worse or lasts more that 5 days
    • fever gets worse or lasts more than 3 days
    • cough comes back, or occurs with rash or headache that lasts.


    These could be signs of a serious condition.

  • Directions

    Directions


    • do not use more than directed (see Overdose warning)
    • shake well before using
    • do not use more than 5 doses in any 24-hour period
    • if needed, repeat dose every 4 hours while symptoms last
    • do not use more than 5 days unless directed by a doctor
    • use dose cup


    Age                                                                       Dose
    Children 6 to under 12 years of age                          2 teaspoonfuls
    Children under 6 years of age                                  do not use

  • Other information

    • each 10 mL (2 tsp)  contains: sodium 5 mg
    • store between 15-30 ° C (59-86° F)
    • do not refrigerate
    • dosing cup provided
  • Overdose warning

    When using this product

    • do not use more than directed (see Overdose warning)
    • Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical even if you do not notice any signs or symptoms.
  • Inactive ingredients

    anhydrous citric acid,edetate disodium,  FD and C Blue #1, FD and C Red # 40, flavors, glycerin, propylene glycol, propyl gallate, purified water,  sodium benzoate, sorbitol, sucralose, xanthan gum

  • Questions?

     1-877-798-5944

  • Product Label

    NDC 68016-224-00

    COMPARE TO THE ACTIVE INGREDIENTS IN CHILDREN’S MUCINEX® COLD, COUGH, and SORE THROAT LIQUID

    Premier Value®
    Children's Cold, Cough, and Sore Throat

    Acetaminophen / Guaifenesin / Dextromethorphan HBr / Phenylephrine HCL

    PAIN RELIEVER / FEVER REDUCER
    EXPECTORANT
    COUGH SUPPRESSANT
    NASAL DECONGESTANT

    Guaifenesin 100 mg
    Dextromethorphan HBr 5 mg
    Phenylephrine HCL 2.5 mg

        * Cough
        * Sore Throat
        * Nasal Congestion
        * Chest Congestion


    For ages 6 to 12

    Mixed Berry Flavor
    4 FL OZ (118mL)

    DO NOT USE IF PRINTED SEAL UNDER CAP IS TORN OR MISSING

    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® Cold, Cough and Sore Throat Liquid
    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
    BX028

    AptaPharma ChildColdCoughSoreThroat  Label

  • INGREDIENTS AND APPEARANCE
    CHILDRENS COLD, COUGH AND SORE THROAT 
    acetaminophen, guaifenesin, dextromethorphan hbr, phenylephrine hcl liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-224
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg  in 10 mL
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg  in 10 mL
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg  in 10 mL
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg  in 10 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYL GALLATE (UNII: 8D4SNN7V92)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SORBITOL (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorBERRY (MIXED BERRY) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68016-224-00118 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34301/01/2013
    Labeler - Chain Drug Consortium, LLC (101668460)
    Registrant - AptaPharma Inc. (790523323)
    Establishment
    NameAddressID/FEIBusiness Operations
    AptaPharma Inc.790523323manufacture(68016-224)