Active Ingredients (In Each Softgels)
Acetaminophen 325 mg
Dextromethorphan HBr 15 mg
Doxylamine succinate 6.25 mg
The following Structured Product Label (SPL) was submitted to the FDA by Health Pharma Usa Llc for the product Nighttime Cold And Flu (NDC 71679-102). 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 ingredients (in each softgels), purpose, uses, warnings, other, keep out of reach of children, direction, other information, 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
Antihistamine
temporarily relieves 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, lasts for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.
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
These could be signs of a serious condition.
If pregnant or breast-feeding,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.
| adults & children 12 yrs & over | 2 softgels with water every 6 hrs |
| children 4 to under 12 yrs | ask a doctor |
| children under 4 yrs | do not use |
D&C yellow# 10, FD&C Blue #1, Gelatin, Glycerin, Polyethylene Glycol 400, Povidone K30, Propylene Glycol, Purified Water, Sorbitol Sorbitan Solution
1-844-832-1138
M-F 9am-5pm EST
Health Pharma USA LLC
Rahway, NJ 07065
www.health-Pharma.us
NDC 71679-102-50
50 Softgels
Nighttime Cold & Flu
Acetaminophen, Doxylamine Succinate, Dextromethorphan HBr
*Compare to the active ingredients in LiquiCaps®
* Please review the disclaimer below.