SANATOS CHILDREN COUGH AND CONGESTION CHERRY (DEXTROMETHORPHAN HBR AND GUAIFENESIN) LIQUID [PHARMADEL LLC]

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SANATOS CHILDREN COUGH AND CONGESTION CHERRY (DEXTROMETHORPHAN HBR AND GUAIFENESIN) LIQUID [PHARMADEL LLC]
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NDC 55758-013-04
Set ID 60437d86-9e13-8d8a-e053-2991aa0a2317
Category HUMAN OTC DRUG LABEL
Packager Pharmadel LLC
Generic Name
Product Class
Product Number
Application Number PART341
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  • Drug Facts

  • Active Ingredients & Purposes

    Active Ingredients
    (in each 5 mL teaspoonful)     		Purposes
    Dextromethorphan HBr 5 mgCough Suppressant
    Guaifenesin 100 mgExpectorant
  • Uses

    • temporarily relieves cough due to minor throat and bronchial irritation as may occur with a common cold
    • helps loosen phlegm (mucus) and thin bronchial secretions to drain the bronchial tubes
  • 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.

    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 a

    • cough that is accompanied by excessive phlegm (mucus)
    • persistent or chronic cough such as occurs with asthma

    Stop use and ask a doctor, if the child has a

    • cough lasts more than 7 days, tends to come back, or accompained by 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 Poison Control Center right away.

  • Directions

    do not give a child more than 6 doses in any 24-hour period

    AgeDose
    Children 6 to under 12 years of age1-2 teaspoonful s (tsps) every 4 hours
    Children 2 to under 6 years of age½-1 teaspoonful (tsp) every 4 hours
    Children under 2 years of ageconsult a doctor
  • Other information

    • sodium: 3 mg per teasponful
    • store at 20- 25º C (68- 77º F)
    • do not refrigerate
    • dosage cup included

    TAMPER EVIDENT: DO NOT USE IF PRINTED SEAL UNDER CAP IS TORN OR MISSING.

  • Inactive ingredients

    Anhydrous citric acid, D&C red #33, dextrose monohydrate, FD&C red #40, flavors, glycerin, maltitol, propylene glycol, purified water, saccharin sodium, sodium benzoate, sucralose, xanthan gum.

  • Questions?

    1-866-359-3478 (M-F) 9 AM to 5 PM EST or www.pharmadel.com

  • Distributed by:

    PHARMDEL®
    Seaford, DE 19973

  • Principal Display Panel

    SanaTos®

    Children


    Cough & Chest Congestion

    Cherry Flavor

    COUGH SUPPRESANT• EXPECTORANT

    Dextromethorphan HBr • Guafenesin

    Helps Loosen Chest Congestion

    • ALCOHOL FREE
    • NON-DROWSY


    For Ages 2 to 12

    4 FL OZ (118 mL)

    Sanatos Children

  • INGREDIENTS AND APPEARANCE
    SANATOS CHILDREN COUGH AND CONGESTION CHERRY 
    dextromethorphan hbr and guaifenesin liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55758-013
    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
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    DEXTROSE MONOHYDRATE (UNII: LX22YL083G)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    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
    ColorredScore    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55758-013-041 in 1 BOX01/01/2016
    1118 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34101/01/2016
    Labeler - Pharmadel LLC (030129680)
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