Otc - Purpose
| Active ingredients (in each 10 ml) | Purposes |
|---|---|
Dextromethorphan HBr, USP 15 mg | Cough suppressant |
Doxylamine Succinate, USP 6.25 mg | Antihistamine |
The following Structured Product Label (SPL) was submitted to the FDA by Raritan Pharmaceuticals Inc for the product Childrens Honeyworks Plus Nighttime Cough Syrup (NDC 68163-661). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - purpose, indications & usage, warnings, do not use, ask a doctor before use if you have, otc - ask doctor/pharmacist, when using this product, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
| Active ingredients (in each 10 ml) | Purposes |
|---|---|
Dextromethorphan HBr, USP 15 mg | Cough suppressant |
Doxylamine Succinate, USP 6.25 mg | Antihistamine |
Warnings
Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers
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
| 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 |
Other information
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
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
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.
* Please review the disclaimer below.