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  5. Label Information: Honey Works Organic Honey

FDA Label for Honey Works Organic Honey

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT (IN EACH 20 ML)
    2. PURPOSE
    3. USES
    4. WARNINGS
    5. OTC - DO NOT USE
    6. ASK A DOCTOR BEFORE USE IF YOU HAVE
    7. OTC - STOP USE
    8. OTC - PREGNANCY OR BREAST FEEDING
    9. OTC - KEEP OUT OF REACH OF CHILDREN
    10. DOSAGE & ADMINISTRATION
    11. STORAGE AND HANDLING
    12. INACTIVE INGREDIENT
    13. QUESTIONS OR COMMENTS?
    14. PRINCIPAL DISPLAY PANEL - 118 ML BOTTLE LABEL

Honey Works Organic Honey Product Label

The following document was submitted to the FDA by the labeler of this product Raritan Pharmaceuticals Inc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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


Otc - Do Not Use



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

Otc - Stop Use



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.


Otc - Pregnancy Or Breast Feeding



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


Otc - 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 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.

    Honey Works Organic Honey Cough Syrup - image 01

    Honey Works Organic Honey Cough Syrup - image 01


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