Otc - Purpose
| Active ingredients (in each 30 mL dose cup) | 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 Nighttime Multi Symptoms (NDC 55758-056). 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 you have, ask a doctor or pharmacist before use if you are, 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 dose cup) | Purposes |
| Acetaminophen 650 mg..... | Pain reliever/ fever reducer |
| Dextromethorphan HBr 30 mg..... | Cough suppressant |
| Doxylamine succinate 12.5 mg..... | Antihistamine |
temporarily relieves these common cold/flu symptoms:
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:
If a skin reaction occurs, stop use and seek medical help right away.
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. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
| age | dose |
| adults & children 12 years & over | 30 mL(2TBSP) every 6 hours |
| children 4 to under 12 years | ask a doctor |
| children under 4 years | do not use |
Tamper Evident: Do not use if imprinted shrink band is missing or broken.
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
call 1-866-359-3478
Pharmadel LLC
Seaford, DE 19973
www.sanatos.com
* Please review the disclaimer below.