CHILDRENS HONEYWORKS PLUS NIGHTTIME COUGH SYRUP- dextromethorphan hbr, doxylamine succinate solution

Childrens HoneyWorks Plus Nighttime Cough Syrup by

Drug Labeling and Warnings

Childrens HoneyWorks Plus Nighttime Cough Syrup by is a Otc medication manufactured, distributed, or labeled by RARITAN PHARMACEUTICALS INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

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

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

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.

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

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

age	dose
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,

QUESTIONS

Questions or comments?

1-866-467-2748

SPL UNCLASSIFIED SECTION

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.

INGREDIENTS AND APPEARANCE

CHILDRENS HONEYWORKS PLUS NIGHTTIME COUGH SYRUP 
dextromethorphan hbr, doxylamine succinate solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68163-661
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	15 mg  in 10 mL
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL)	DOXYLAMINE SUCCINATE	6.25 mg  in 10 mL

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
HONEY (UNII: Y9H1V576FH)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)

Product Characteristics
Color		Score
Shape		Size
Flavor	GRAPE	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68163-661-04	1 in 1 CARTON	02/01/2023
1		118 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	02/01/2023

Labeler - RARITAN PHARMACEUTICALS INC (127602287)