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 Advanced Rx Llc for the product Multi-symptom Nighttime Cold And Flu Relief (NDC 80513-316). 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, otc - pregnancy or breast feeding, 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 and 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
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 (1-800-222-1222) right away. Quick medical attention is critical for adults and for children even if you do not notice any signs or symptoms.
| adults and children 12 years and over | take 2 softgels with water every 6 hours |
| children 4 to under 12 years | ask a doctor |
| children under 4 years | do not use |
D&C Yellow No10, FD&C Blue No 1, gelatin, glycerin, polyethylene glycol 400, povidone K30, propylene glycol, purified water, sorbitol sorbitan solution.
call toll-free 1-800-630-8895
Advanced Rx
1942 NE 163rd St,
North Miami Beach, FL 33162 U.S.A.
NDC 80513-316-50
*Compare to the active ingredients in Vicks ®NyQuil ®Cold & Flu LiquiCaps ®
50 Softgels
MULTI-SYMPTOM NIGHTTIME COLD & FLU RELIFE
Acetaminophen,
Dextromethorphan HBr,
Doxylamine Succinate
• Pain Reliever
• Fever Reducer
• Cough Suppressant
• Antihistamine
*This product is not manufactured or distributed by the owner of the registered trademark Vicks ®NyQuil ®Cold & Flu LiquiCaps ®
* Please review the disclaimer below.