FDA Label for Honey Works Kids Honey Cough Syrup
View Indications, Usage & Precautions
- ACTIVE INGREDIENT (IN EACH 5 ML)
- PURPOSE
- USES
- WARNINGS
- OTC - DO NOT USE
- ASK A DOCTOR BEFORE USE IF YOU HAVE
- OTC - STOP USE
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
- QUESTIONS OR COMMENTS?
- PRINCIPAL DISPLAY PANEL - 118 ML BOTTLE LABEL
Honey Works Kids Honey Cough Syrup Product Label
The following document was submitted to the FDA by the labeler of this product Raritan Pharmaceuticals Inc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredient (In Each 5 Ml)
Dextromethorphan HBr, USP 5 mg
Purpose
▪ Cough suppressant
Uses
▪ temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold▪ helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes
Warnings
Warnings
Otc - Do Not Use
Do not use 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
▪ cough that occurs with too much phlegm (mucus)▪ cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema
Otc - Stop Use
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.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222.
Dosage & Administration
Directions
▪ shake well before use▪ do not take more than 6 doses in any 24-hour period▪ measure only with dosing cup provided▪ do not use dosing cup with other products▪ ml = milliliter▪ doses as follows or as directed by doctor
| age | dose |
|---|---|
children under 6 years | do not use |
children 6 years to under 12 years | 5-10 mL every 4 hours |
Storage And Handling
Other information
▪ store at room temperature. Do not refrigerate▪ alcohol free
Inactive Ingredient
Inactive ingredients
Natural citric acid, natural flavor, organic honey, purified water
Questions Or Comments?
1-866-467-2748
Principal Display Panel - 118 Ml Bottle Label
NDC# 68163-771-04
Kids Honey Works™
HONEY
Cough Syrup
Plus Dextromethorphan HBr
Cough Suppressant
• 100% U.S. Sourced Natural Honey• For Ages 6 years +• No Artificial Colors• GMO-Free• No Artificial Flavors• Gluten-Free• Soy-Free• Dairy-Free• Peanut-Free• Tree Nut-Free• Zero Trans Fat
Up to 6 Hours Relief
Clinically Proven Ingredient
Great Tasting Syrup
4 FL OZ (118 ml)
This great-tasting product offers fast & effective cough relief and is made with 100% U.S. sourced natural, dark honey.
Also try HoneyWorks™ Kids Soothing Throat Spray
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Made in USA with domestic and foreign components
Distributed by: Lifelab Health LLC
6574 N. State Road 7 #361
Coconut Creek, FL 33073
IMPORTANT: Keep this carton for future reference on full labeling. |
* Please review the disclaimer below.
