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  5. Label Information: Childrens Honeyworks Plus Nighttime Cough Syrup

FDA Label for Childrens Honeyworks Plus Nighttime Cough Syrup

View Indications, Usage & Precautions

Table of Contents

    1. OTC - PURPOSE
    2. INDICATIONS & USAGE
    3. WARNINGS
    4. DO NOT USE
    5. ASK A DOCTOR BEFORE USE IF YOU HAVE
    6. OTC - ASK DOCTOR/PHARMACIST
    7. WHEN USING THIS PRODUCT
    8. OTC - STOP USE
    9. OTC - PREGNANCY OR BREAST FEEDING
    10. OTC - KEEP OUT OF REACH OF CHILDREN
    11. DOSAGE & ADMINISTRATION
    12. STORAGE AND HANDLING
    13. INACTIVE INGREDIENT
    14. OTC - QUESTIONS
    15. OTHER
    16. PRINCIPAL DISPLAY PANEL - 118 ML BOTTLE CARTON

Childrens Honeyworks Plus Nighttime Cough Syrup 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.

Otc - Purpose



Active ingredients (in each 10 ml)Purposes

Dextromethorphan HBr, USP 15 mg

Cough suppressant

Doxylamine Succinate, USP 6.25 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
    • agedose

    children under 6 years

    do not use

    children 6 to under 12 years

    10 ml every 6 hours

    adults and children 12 years and older

    20 ml every 6 hours


Storage And Handling



Other information

  • •each 10 ml contains: sodium 2 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 68163-661-04

HONEYWORKS™ Plus

Children’s

COUGH SYRUP

Dextromethorphan HBr
(COUGH SUPPRESSANT)
Doxylamine Succinate (ANTIHISTAMINE)

NIGHTTIME FORMULA

GRAPE FLAVOR

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 6 YEARS & OLDER

    ALSO TRY HONEYWORKS™ KIDS SOOTHING THROAT SPRAY

    4 FL OZ (118 mL)

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


* Please review the disclaimer below.