Honeyworks Children’s Cough Syrup Drug Facts

SPL v3

SPL

SPL Set ID 43230b3b-2984-4924-b46d-dc73a8194d23

Route

ORAL

Published

Effective Date 2023-02-17

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Dextromethorphan (15 mg) Doxylamine (6.25 mg)

Inactive Ingredients

Anhydrous Citric Acid Honey Water Sodium Benzoate

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2023-02-01

Description

Active ingredients (in each 10 ml) Purposes Dextromethorphan HBr, USP 15 mg Cough suppressant Doxylamine Succinate, USP 6.25 mg Antihistamine

Medication Information

Warnings and Precautions

Warnings

Indications and 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

Dosage and 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

Description

Active ingredients (in each 10 ml) Purposes Dextromethorphan HBr, USP 15 mg Cough suppressant Doxylamine Succinate, USP 6.25 mg Antihistamine

Section 42229-5

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

Section 44425-7

Other information

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

Section 50565-1

Keep out of reach of children.In case of overdose, get medical help or contact a Poison Control Center right away.

Section 50566-9

Stop use and ask a doctor ifcough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.

Section 50568-5

Ask a doctor or pharmacist before use if you aretaking sedatives or tranquilizers

Section 51727-6

Inactive ingredients

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

Section 53413-1

Questions or comments?

1-866-467-2748

Section 53414-9

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

Section 55105-1

Active ingredients (in each 10 ml)	Purposes
Dextromethorphan HBr, USP 15 mg	Cough suppressant
Doxylamine Succinate, USP 6.25 mg	Antihistamine

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.

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

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

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.

Structured Label Content

Indications and Usage (34067-9)

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

Dosage and Administration (34068-7)

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

Warnings and Precautions (34071-1)

Warnings

Section 42229-5 (42229-5)

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

Section 44425-7 (44425-7)

Other information

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

Section 50565-1 (50565-1)

Keep out of reach of children.In case of overdose, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor ifcough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you aretaking sedatives or tranquilizers

Section 51727-6 (51727-6)

Inactive ingredients

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

Section 53413-1 (53413-1)

Questions or comments?

1-866-467-2748

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Active ingredients (in each 10 ml)	Purposes
Dextromethorphan HBr, USP 15 mg	Cough suppressant
Doxylamine Succinate, USP 6.25 mg	Antihistamine

Do Not Use (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.

When Using This Product (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

Ask A Doctor Before Use If You Have (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

Principal Display Panel 118 Ml Bottle Carton (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.

Advanced Ingredient Data

[{"name": "ANHYDROUS CITRIC ACID", "unii": "XF417D3PSL", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HONEY", "unii": "Y9H1V576FH", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM BENZOATE", "unii": "OJ245FE5EU", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DEXTROMETHORPHAN", "unii": "7355X3ROTS", "classCode": "ACTIB", "strengthNumerator": "15", "strengthDenominator": "10", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "DOXYLAMINE", "unii": "95QB77JKPL", "classCode": "ACTIB", "strengthNumerator": "6.25", "strengthDenominator": "10", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"34067-9": "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", "34068-7": "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", "34071-1": "Warnings", "42229-5": "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", "44425-7": "Other information each 10 ml contains: sodium 2 mg store at room temperature", "50565-1": "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.", "50566-9": "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.", "50568-5": "Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers", "51727-6": "Inactive ingredients citric acid, natural flavor, organic honey, purified water, sodium benzoate,", "53413-1": "Questions or comments? 1-866-467-2748", "53414-9": "If pregnant or breast-feeding, ask a health professional before use.", "55105-1": "Active ingredients (in each 10 ml) Purposes Dextromethorphan HBr, USP 15 mg Cough suppressant Doxylamine Succinate, USP 6.25 mg Antihistamine", "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.", "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", "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", "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."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:40.853128 · Updated: 2026-03-14T23:13:02.501548