Other
Drug Facts
Distributed by:
Advanced Rx
1942 NE 163rd St,
North Miami Beach, FL 33162 U.S.A.
*This product is not manufactured or distributed by the owner of the registered trademark Vicks ®NyQuil ®Cold & Flu LiquiCaps ®
The following Structured Product Label (SPL) was submitted to the FDA by Advanced Rx Llc for the product Nighttime Cold And Flu Relief (NDC 80513-304). 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 other, active ingredients (in each softgel), purpose, uses, warnings, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Drug Facts
Distributed by:
Advanced Rx
1942 NE 163rd St,
North Miami Beach, FL 33162 U.S.A.
*This product is not manufactured or distributed by the owner of the registered trademark Vicks ®NyQuil ®Cold & Flu LiquiCaps ®
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
• more than 4 doses in 24 hours, which is the maximum daily amount for this product
• with other drugs containing acetaminophen
• 3 or more alcoholic drinks every day while using this product
Allergy alert:Acetaminophen may cause severe skin reactions.
Symptoms may include:
• skin reddening
• blisters
• rash
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.
If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children.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 No. 10, FD&C Blue No. 1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution, titanium dioxide.
1-800-630-8895
* Please review the disclaimer below.