Otc - Active Ingredient
Menthol 10mg
Dentemp Nightmelt
FDA Label NDC 73653-220
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Doc Brands for the product Dentemp Nightmelt (NDC 73653-220). 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, inactive ingredient, otc - ask doctor, otc - stop use, otc - questions, otc - pregnancy or breast feeding, otc - keep out of reach of children, warnings, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Inactive Ingredient
Xylitol, Polyvinylpyrrolidone K90, Steviol glycosides, Natural Cherry Flavoring, Carbopol 71G, Silicon Dioxide, Magnesium Stearate, Natural Red Color, Stearic Acid
Otc - Ask Doctor
Ask a doctor before use if you have: • persistent or chronic cough such as occurs with smoking, asthma, or emphysema • cough accompanied by excessive phlegm (mucus)
Otc - Stop Use
Stop use and ask a doctor if: • cough persists more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition. • sore mouth does not improve in 7 days • irritation, pain, or redness persists or worsens
Otc - Questions
Questions or comments? 833-362-2763 or [email protected]
Otc - Pregnancy Or Breast Feeding
If pregnant or breastfeeding, ask a health care professional before use. Keep out of reach of children
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Warnings
Sore throat warning: if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever. headache, rash, swelling, nausea, or vomiting, consult a doctor promptly. These symptoms may be serious.
Instructions For Use
Directions • adults and children 5 years of age and older, apply 1 tablet and allow it to slowly dissolve. Repeat every 2 hours as needed. Place the tablet on a clean, dry finger with the colored, curved side up. Place the colored, curved side against the roof of the mouth and hold in place for 10 seconds. The tablet will begin to slowly dissolve and provide soothing relief for more than an hour. Do not remove the tablet before it dissolves. In case of discomfort, the tablet may be removed by gently peeling the tablet from the sides while washing with warm water. Do not use any instrument to remove the tablet.
Otc - Purpose
Purpose to aid as a cough suppressant and provide sore throat relief
Indications & Usage
For the temporary relief of cough due to minor throat irritaion and occasional minor sore throat
Dosage & Administration
adults and children 5 years of age and older, apply 1 tablet and allow it to slowly dissolve. Repeat every 2 hours as needed up to 7 days.
* Please review the disclaimer below.
