Label: CHILDRENS HONEYWORKS PLUS NIGHTTIME COUGH SYRUP- dextromethorphan hbr, doxylamine succinate solution
- NDC Code(s): 68163-661-04
- Packager: RARITAN PHARMACEUTICALS INC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated February 17, 2023
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- ACTIVE INGREDIENT
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INDICATIONS & USAGE
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- Uses
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- temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
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- temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
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- runny nose
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- sneezing
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- itchy, watery eyes
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- itching of the nose or throat
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- controls the impulse to cough to help you sleep
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WARNINGS
Warnings
Do not use
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- to sedate a child or to make a child sleepy
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- 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
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- trouble urinating due to an enlarged prostate gland
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- glaucoma
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- a cough that occurs with too much phlegm (mucus)
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- a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysema
When using this product
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- do not use more than directed
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- marked drowsiness may occur
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- avoid alcoholic drinks
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- alcohol, sedatives, and tranquilizers may increase drowsiness
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- be careful when driving a motor vehicle or operating machinery
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- excitability may occur, especially in children
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DOSAGE & ADMINISTRATION
Directions
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- measure only with dosing cup provided
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- keep dosing cup with product
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- ml = milliliter
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- 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
- INACTIVE INGREDIENT
- QUESTIONS
- SPL UNCLASSIFIED SECTION
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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
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- NO PARABENS
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- NO DYES
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- NO HIGH FRUCTOSE CORN SYRUP
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- NO ARTIFICIAL FLAVORS
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- NON-GMO
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- SOY-FREE
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- GLUTEN FREE
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- DAIRY-FREE
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- PEANUT-FREE
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- TREE NUT-FREE
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- 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.
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INGREDIENTS AND APPEARANCE
CHILDRENS HONEYWORKS PLUS NIGHTTIME COUGH SYRUP
dextromethorphan hbr, doxylamine succinate solutionProduct 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)