Honey Works Syrup
FDA Label NDC 68163-774

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Raritan Pharmaceuticals Inc for the product Honey Works (NDC 68163-774). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient (in each 20 ml), purpose, uses, warnings, otc - do not use, ask a doctor before use if you have, otc - stop use, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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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