Label: HONEY WORKS KIDS HONEY COUGH SYRUP- dextromethorphan hbr syrup

  • NDC Code(s): 68163-771-04
  • Packager: RARITAN PHARMACEUTICALS INC
  • 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 January 7, 2023

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  • INDICATIONS & USAGE

    Active Ingredient (in each 5 mL)

    Dextromethorphan HBr, USP 5 mg

    Purpose

    ▪
    Cough suppressant

    Uses

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

    Warnings

    Do not use if you are now 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 taking this product.

    Ask a doctor before use if you have

    ▪
    cough that occurs with too much phlegm (mucus)
    ▪
    cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema

    Stop use and ask a doctor if cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.

    If pregnant or breast-feeding, ask a health professional before use.

    Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222.

  • DOSAGE & ADMINISTRATION

    Directions

    ▪
    shake well before use
    ▪
    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
    ▪
    ml = milliliter
    ▪
    doses as follows or as directed by doctor
    agedose

    children under 6 years

    do not use

    children 6 years to under 12 years

    5-10 mL every 4 hours
  • STORAGE AND HANDLING

    Other information

    ▪
    store at room temperature. Do not refrigerate
    ▪
    alcohol free
  • INACTIVE INGREDIENT

    Inactive ingredients

    Natural citric acid, natural flavor, organic honey, purified water

    Questions or comments?

    1-866-467-2748

  • PRINCIPAL DISPLAY PANEL - 118 ml Bottle Label

    NDC# 68163-771-04

    Kids Honey Works™

    HONEY

    Cough Syrup

    Plus Dextromethorphan HBr

    Cough Suppressant

    •
    100% U.S. Sourced Natural Honey
    •
    For Ages 6 years +

    Up to 6 Hours Relief

    Clinically Proven Ingredient

    Great Tasting Syrup

    4 FL OZ (118 ml)

    This great-tasting product offers fast & effective cough relief and is made with 100% U.S. sourced natural, dark honey.

    Also try HoneyWorks™ Kids Soothing Throat Spray

    •
    No Artificial Colors
    •
    GMO-Free
    •
    No Artificial Flavors
    •
    Gluten-Free
    •
    Soy-Free
    •
    Dairy-Free
    •
    Peanut-Free
    •
    Tree Nut-Free
    •
    Zero Trans Fat

    Follow us on Facebook and Twitter for coupons & special offers.

    Made in USA with domestic and foreign components

    Distributed by: Lifelab Health LLC

    6574 N. State Road 7 #361

    Coconut Creek, FL 33073

    IMPORTANT: Keep this carton for future reference on full labeling.

    Kids Honey Cough Syrup
  • INGREDIENTS AND APPEARANCE
    HONEY WORKS  KIDS HONEY COUGH SYRUP
    dextromethorphan hbr syrup
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68163-771
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE5 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    HONEY (UNII: Y9H1V576FH)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68163-771-041 in 1 CARTON12/26/2022
    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 finalpart34112/26/2022
    Labeler - RARITAN PHARMACEUTICALS INC (127602287)
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