Honeyworks Adult Cough Syrup Drug Facts

Honeyworks Adult Cough Syrup Drug Facts
SPL v3
SPL
SPL Set ID 778ec0df-2baa-4ae3-8072-38ab4e3bf2be
Route
ORAL
Published
Effective Date 2023-02-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dextromethorphan (20 mg) Doxylamine (12.5 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 20 ml) Purposes Dextromethorphan HBr, USP 20 mg Cough suppressant Doxylamine Succinate, USP 12.5 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
  • this adult products is not intended for use in children under 12 years of age
age dose

adults and children 12 years and older

20 ml every 6 hours

children under 12 years

Do not use

Description

Active ingredients (in each 20 ml) Purposes Dextromethorphan HBr, USP 20 mg Cough suppressant Doxylamine Succinate, USP 12.5 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 20 ml contains: sodium 3 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 20 ml) Purposes

Dextromethorphan HBr, USP 20 mg

Cough suppressant

Doxylamine Succinate, USP 12.5 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 68163-660-08

HONEYWORKS™ Plus

Adult

COUGH SYRUP

Dextromethorphan HBr

(COUGH SUPPRESSANT)

Doxylamine Succinate (ANTIHISTAMINE)

NIGHTTIME FORMULA

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 12 YEARS & OLDER

ALSO TRY HONEYWORKS™ KIDS SOOTHING THROAT SPRAY

8 FL OZ (236 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
  • this adult products is not intended for use in children under 12 years of age
age dose

adults and children 12 years and older

20 ml every 6 hours

children under 12 years

Do not use

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 20 ml contains: sodium 3 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 20 ml) Purposes

Dextromethorphan HBr, USP 20 mg

Cough suppressant

Doxylamine Succinate, USP 12.5 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 68163-660-08

HONEYWORKS™ Plus

Adult

COUGH SYRUP

Dextromethorphan HBr

(COUGH SUPPRESSANT)

Doxylamine Succinate (ANTIHISTAMINE)

NIGHTTIME FORMULA

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 12 YEARS & OLDER

ALSO TRY HONEYWORKS™ KIDS SOOTHING THROAT SPRAY

8 FL OZ (236 mL)

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


Advanced Ingredient Data


Raw Label Data

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