FDA Label for Dentemp Nightmelt
View Indications, Usage & Precautions
Dentemp Nightmelt Product Label
The following document was submitted to the FDA by the labeler of this product Doc Brands. 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.
Otc - Active Ingredient
Menthol 10mg
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.
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