Drug Facts
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The following Structured Product Label (SPL) was submitted to the FDA by Pharmadel Llc for the product Sanatos (NDC 55758-510). 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, otc - purpose, 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) | Purposes |
| Acetaminophen 325 mg.............. | Pain reliever/ fever reducer |
| Dextromethorphan HBr 15 mg ...... | Cough suppressant |
| Doxylamine succinate 6.25 mg ..... | Antihistamine |
Temporarily relieves cough-cold symptoms
Liver warning:This product contains acetaminophen. Severe liver damage may occur if you take
Allergy alert: Acetaminophenmay cause severe skin reactions. Symptoms may include:
If a skin reaction occurs, stop use and seek medical help right away.
These could be signs of a serious condition.
ask a health professional before use.
In case of accidental 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 | 2 softgels every 6 hours, do not exceed 8 softgels in a 24 hour period |
| children 4 to under 12 years | consult a doctor |
| children under 4 years | do not use |
D&C yellow #10, FD&C blue #1, gelatin, glycerin, polyethylene glycol 400, povidone k-30, propylene glycol, sorbitol sorbitan solution, water
+1-866-359-3478(M-F) 9 AM - 5 PM EST or www.pharmadel.com
PHARMADEL LLC
New Castle, DE 19720
www.pharmadel.com
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