Honey Works Syrup
FDA Label NDC 68163-771

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 68163-771). 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 5 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.

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

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
  • ▪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 (Image 01)

      Kids Honey Cough Syrup (Image 01)

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