Active Ingredient (In Each 15 Ml Tablespoon)
Acetaminophen 325 mg
Dextromethorphan HBr 15 mg
Doxylamine succinate 6.25 mg
The following Structured Product Label (SPL) was submitted to the FDA by We Care Distributor Inc. for the product Nite Time (NDC 70005-046). 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 active ingredient (in each 15 ml tablespoon), 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, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Acetaminophen 325 mg
Dextromethorphan HBr 15 mg
Doxylamine succinate 6.25 mg
Pain reliever/fever reducer
Cough suppressant
Nasal decongestant
temporarily relieves common cold/flu symptoms:
Liver warning: This product contains acetaminophen. The maximum daily dose of this product is 4 doses. Severe liver damage may occur if adult/child takes:
Sore throat warning: If sore throat is severe, persists for more than two 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.
Overdose warning: Taking more than recommended dose may 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 | 30 mL every 6 hours |
| children 4 to under 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, purified water, saccharin sodium, sodium citrate, sodium benzoate
1-888-705-WECARE (Mon-Fri 9am-5pm EST) or www.wecaredistributor.com
See New Warnings Information
Compare to NyQuil® Cold & Flu Active Ingredients
NiteTime
Cold & Flu
Pain Reliever, Fever Reducer, Cough Suppressant, Antihistamine
Multi-Symptom Relief
Aches, Fever - Acetaminophen
Cough - Dextromethorphan HBr
Sneezing, Runny Nose - Doxylamine Succinate
Original Flavor
10% Alcohol
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