Label: HONEY WORKS ORGANIC HONEY- dextromethorphan hbr syrup

  • 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 July 22, 2022

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  • INDICATIONS & USAGE

    Active Ingredient (in each 20 mL)

    Dextromethorphan HBr, USP 20 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
    ▪
    keep dosing cup with product
    ▪
    ml = milliliter
    ▪
    doses as follows or as directed by doctor
    agedose

    children 12 years

    Do not use

    Adults and children 12 years and over

    20 mL every 4 hours
  • STORAGE AND HANDLING

    Other information

    ▪
    store at room temperature
    ▪
    alcohol free
  • INACTIVE INGREDIENT

    Inactive ingredients

    citric acid, natural and artificial flavors, organic honey, purified water, sodium benzoate.

    Questions or comments?

    1-866-467-2748

  • PRINCIPAL DISPLAY PANEL - 118 ml Bottle Label

    NDC# 68163-774-04

    Honey Works™

    ORGANIC HONEY

    COUGH SYRUP

    PLUS DEXTROMETHORPHAN HBr

    COUGH SUPPRESSANT

    UP TO 6 HOURS OF RELIEF 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 CERTIFIED-ORGANIC DARK HONEY.

    •
    NO ARTIFICIAL COLORS
    •
    NON-GMO
    •
    NO ARTIFICIAL FLAVOR
    •
    SOY-FREE
    •
    GLUTEN-FREE
    •
    DAIRY-FREE
    •
    PEANUT-FREE
    •
    TREE NUT-FREE
    •
    ZERO TRANS FAT

    FOR AGES 12 YEARS & OLDER

    ALSO TRY HONEYWORKS™ ADULTS SOOTHING THROAT SPRAY

    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.

    Organinc Honey Cough Syrup
  • INGREDIENTS AND APPEARANCE
    HONEY WORKS  ORGANIC HONEY
    dextromethorphan hbr syrup
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68163-774
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE20 mg  in 20 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    HONEY (UNII: Y9H1V576FH)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68163-774-041 in 1 CARTON05/20/2019
    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 finalpart34105/20/2019
    Labeler - RARITAN PHARMACEUTICALS INC (127602287)
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