Otc - Purpose
Active ingredients (in each 30 mL) | Purposes |
| Acetaminophen 650 mg | Pain reliever/ fever reducer |
| Dextromethorphan HBr 30 mg | Cough suppressant |
| Doxylamine succinate 12.5 mg | Antihistamine |
The following Structured Product Label (SPL) was submitted to the FDA by Pharmadel Llc for the product Sanatos (NDC 55758-416). 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 - purpose, uses, warnings, do not use, ask a doctor before use if user, ask a doctor or pharmacist before use if user is, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Active ingredients (in each 30 mL) | Purposes |
| Acetaminophen 650 mg | Pain reliever/ fever reducer |
| Dextromethorphan HBr 30 mg | Cough suppressant |
| Doxylamine succinate 12.5 mg | Antihistamine |
Temporarily relieves common cold/flu symptoms associated with
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
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.
These could be signs of a serious condition.
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.
| adults & children 12 years & over | 30 mL every 4 hours, do not exceed (child) 3 doses and (adult) 4 doses in 24 hours |
| children under 12 years | ask a doctor |
citric acid, D&C yellow#10, FD&C Green# 3, FD&C yellow# 6, flavor, glycerin, polythylene glycol, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium citrate, sucrose
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