Drug Facts
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The following Structured Product Label (SPL) was submitted to the FDA by Pharmadel Llc for the product Sanatos Nighttime Relief (NDC 55758-515). 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 drug facts, active ingredients and purposes, purposes, uses, warnings, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
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Active ingredients(in each softgel) Purpose
Acetaminophen 325mg ...........................................................Pain reliever/ fever reducer
Dextromethorphan HBr 20mg....................................................Cough suppressant
Doxylamine succinate 12.5mg.................................................... Antihistamine
Temporarily relieves the common cold/flu symptoms associated with
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
Allergy Alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied, or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.
ask a health professional before use.
In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
| Age | Dose |
| adults and children 12 years and older | two (2) softgels every 6 hours, do not exceed 8 softgels in 24 hours |
| children 4 to under 12 years | ask a doctor |
| children under 4 years | do not use |
D&C yellow #10, FD&C blue #1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution, titanium dioxide
+1-866-359-3478 (M-F) 9AM – 5PM EST or www.pharmadel.com
Pharmadel LLC
New Castle, DE 19947
+1-866-359-3478
†This product is not manufactured or distributed by Procter & Gamble, owner of the registered trademark Vicks® Nyquil® Liquicap
* Please review the disclaimer below.