Honeyworks Plus Adult Nighttime Cough Syrup Solution
FDA Label NDC 68163-660

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 Honeyworks Plus Adult Nighttime Cough Syrup (NDC 68163-660). 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 otc - purpose, indications & usage, warnings, do not use, ask a doctor before use if you have, otc - ask doctor/pharmacist, when using this product, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Purpose

Active ingredients (in each 20 ml)Purposes

Dextromethorphan HBr, USP 20 mg

Cough suppressant

Doxylamine Succinate, USP 12.5 mg

Antihistamine

Indications & Usage

  • ▪Uses
  • ▪temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
  • ▪temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
    • ▪runny nose
    • ▪sneezing
    • ▪itchy, watery eyes
    • ▪itching of the nose or throat
    • ▪controls the impulse to cough to help you sleep

Warnings

Warnings

Do Not Use

  • ▪to sedate a child or to make a child sleepy
  • ▪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

  • ▪trouble urinating due to an enlarged prostate gland
  • ▪glaucoma
  • ▪a cough that occurs with too much phlegm (mucus)
  • ▪a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysema

Otc - Ask Doctor/Pharmacist

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers

When Using This Product

  • ▪do not use more than directed
  • ▪marked drowsiness may occur
  • ▪avoid alcoholic drinks
  • ▪alcohol, sedatives, and tranquilizers may increase drowsiness
  • ▪be careful when driving a motor vehicle or operating machinery
  • ▪excitability may occur, especially in children

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.

Dosage & Administration

Directions

  • ▪measure only with dosing cup provided
  • ▪keep dosing cup with product
  • ▪ml = milliliter
  • ▪do not take more than 4 doses in any 24-hour period
  • ▪this adult products is not intended for use in children under 12 years of age
    • agedose

    adults and children 12 years and older

    20 ml every 6 hours

    children under 12 years

    Do not use

Storage And Handling

Other information

  • each 20 ml contains: sodium 3 mg
  • store at room temperature

Inactive Ingredient

Inactive ingredients

citric acid, natural flavor, organic honey, purified water, sodium benzoate,

Otc - Questions

Questions or comments?

1-866-467-2748

Other

Made in the U.S.A. with domestic and foreign ingredients

Distributed by Lifelab Health LLC

5300 W Hillsboro Blvd, Suite 202,

Coconut Creek, FL 33073

Principal Display Panel - 118 Ml Bottle Carton

NDC 68163-660-08

HONEYWORKS™ Plus

Adult

COUGH SYRUP

Dextromethorphan HBr
(COUGH SUPPRESSANT)
Doxylamine Succinate (ANTIHISTAMINE)

NIGHTTIME FORMULA

THIS GREAT-TASTING PRODUCT OFFERS FAST & EFFECTIVE COUGH RELIEF NAD IS MADE WITH ORGANIC DARK HONEY

  • NO PARABENS
  • NO DYES
  • NO HIGH FRUCTOSE CORN SYRUP
  • NO ARTIFICIAL FLAVORS
  • NON-GMO
  • SOY-FREE
  • GLUTEN FREE
  • DAIRY-FREE
  • PEANUT-FREE
  • TREE NUT-FREE
  • ZERO TRANS FAT

    • FOR AGES 12 YEARS & OLDER

    ALSO TRY HONEYWORKS™ KIDS SOOTHING THROAT SPRAY

    8 FL OZ (236 mL)

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

* Please review the disclaimer below.