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

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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HoneyWorks Children’s Cough Syrup Drug facts

Active ingredients (in each 10 ml)Purposes

Dextromethorphan HBr, USP 15 mg

Cough suppressant

Doxylamine Succinate, USP 6.25 mg

Antihistamine

▪
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

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.

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

Other information

•
each 10 ml contains: sodium 2 mg
•
store at room temperature

Inactive ingredients

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

Questions or comments?

1-866-467-2748

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.

Childrens Honeyworks NT cough DM 4 fl oz (118 ml)
CHILDRENS HONEYWORKS PLUS NIGHTTIME COUGH SYRUP 
dextromethorphan hbr, doxylamine succinate solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68163-661
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE15 mg  in 10 mL
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE6.25 mg  in 10 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
HONEY (UNII: Y9H1V576FH)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
Product Characteristics
Color    Score    
ShapeSize
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68163-661-041 in 1 CARTON02/01/2023
1118 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34102/01/2023
Labeler - RARITAN PHARMACEUTICALS INC (127602287)

Revised: 2/2023
Document Id: 43230b3b-2984-4924-b46d-dc73a8194d23
Set id: 43230b3b-2984-4924-b46d-dc73a8194d23
Version: 1
Effective Time: 20230217
 
RARITAN PHARMACEUTICALS INC