Otc - Active Ingredient
Active ingredient (in each chewable tablet)
Dextromethorphan HBr 10 mg
Doxylamine succinate 6.25 mg
The following Structured Product Label (SPL) was submitted to the FDA by Cvs for the product Cvs Dex-dox Kids Nighttime Cough Suppressant (NDC 51316-081). 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 - active ingredient, otc - purpose, indications & usage, warnings, otc - ask doctor, otc - ask doctor/pharmacist, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Active ingredient (in each chewable tablet)
Dextromethorphan HBr 10 mg
Doxylamine succinate 6.25 mg
Purpose
Cough suppressant
Antihistamine
Uses
Warnings
Do not use
Ask a doctor before use if you have
Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers
When using this product
Stop use and ask doctor if
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 (1-800-222-1222) right away.
Directions
adults and children 12 years of age and over - 2 chewable tablets every 4 hours, not to exceed 12 chewable tablets in any 24-hour period
children ages 6 to 12 years - 1 chewable tablet every 4 hours, not to exceed 6 chewable tablets in any 24-hour period
children ages 6 and under - do not use
Other information
Inactive ingredients: Anhydrous citric acid, corn syrup, cranberry juice concentrate, FD&C Blue #1, FD&C Red #40, glycerin, malic acid, medium chain triglycerides, natural & artificial flavors, pectin, sodium chloride, trisodium citrate (anhydrous), sucralose, sucrose, water.
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