Otc - Purpose
| Active ingredients (in each 15 mL tablespoon) | Purpose |
|---|---|
| Acetaminophen 325 mg | Pain reliever/fever reducer |
| Dextromethorphan HBr, 15 mg | Cough suppressant |
| Doxylamine succinate 6.25 mg | Antihistamine |
The following Structured Product Label (SPL) was submitted to the FDA by Rij Pharmaceutical Corporation for the product Nite Time (NDC 53807-521). 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, liver warning, sore throat warning, 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, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
| Active ingredients (in each 15 mL tablespoon) | Purpose |
|---|---|
| Acetaminophen 325 mg | Pain reliever/fever reducer |
| Dextromethorphan HBr, 15 mg | Cough suppressant |
| Doxylamine succinate 6.25 mg | Antihistamine |
temporarily relieves common cold/flu symptoms:
This product contains acetaminophen. Severe liver damage may occur if you take
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.
If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children.
Taking more than the recommended dose can cause serious health problems. 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 and children 12 years and over | 2 TBSP (30 ml) every 6 hrs |
| Children 4 to 12 years | Ask a doctor |
| Children under 4 years | Do not use |
alcohol, citric acid, D&C Yellow No. 10, FD&C Green No. 3, FD& C Yellow No. 6, flavor, high fructose corn syrup, polyethylene glycol, propylene glycol, saccharin sodium, sodium citrate, sodium benzoate, water
* Please review the disclaimer below.