Active Ingredient & Purposes
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Sanatos Lozenge
FDA Label NDC 55758-518
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Pharmadel Llc for the product Sanatos (NDC 55758-518). 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 active ingredient & purposes, otc - purpose, uses, warnings, ask a doctor before use if you have, when using this product, stop use and ask a doctor if, if pregnant or breastfeeding,, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
| Active ingredient (in each lozenge) | Purposes |
| Menthol 5.4 mg................................................ | Cough suppressant / oral anesthetic |
Uses
For the temporary relief of
- occasional minor irritation, pain, sore mouth and sore throat
- cough as may occur with a cold
Warnings
Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by high fever, headache, rash, nausea or vomiting, consult a doctor promptly. These may be serious.
Ask A Doctor Before Use If You Have
- a persistent or chronic cough such as occurs with smoking, asthma or emphysema
- a cough that is accompanied by excessive phlegm (mucus)
When Using This Product
do not exceed recommended dosage
Stop Use And Ask A Doctor If
- sore mouth symptoms do not improve in 7 days
- irritation, pain or redness persist or worsens
- cough persists for more than 7 days, tends to recur, or is accompanied by fever, rash or persistent headache. These could be signs of a serious condition.
If Pregnant Or Breastfeeding,
ask a health professional before use.
Keep Out Of The Reach Of Children.
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Directions
- adults and children 4 years of age and older:
- dissolve (1) lozenge slowly in mouth
- repeat every 2 hours as needed or as directed by a doctor
- children under 4 years of age: consult a doctor
Other Information
- store in cool dry place below 77°F (25°C)
- protect from heat and light
- do not use if package is torn or punctured
Inactive Ingredients
anhydrous citric acid, corn syrup, eucalyptus oil, FD&C blue #1, FD&C red #40, flavors, hypromellose, sucralose, sucrose
Questions Or Comments?
+1-866-359-3478 (M-F) 9 AM to 5 PM EST or www.pharmadel.com
Dist By/ Por:
PHARMADEL LLC
New Castle, DE 19720
Made in India/ Hecho en India
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