Active Ingredients (In Each 30 Ml)
Acetaminophen 650 mg
Diphenhydramine HCl 25 mg
Phenylephrine HCl 10 mg
The following Structured Product Label (SPL) was submitted to the FDA by Top Care (topco Associates Llc) for the product Flu Relief Therapy (NDC 36800-317). 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 30 ml), purposes, uses, warnings, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are taking, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Acetaminophen 650 mg
Diphenhydramine HCl 25 mg
Phenylephrine HCl 10 mg
Pain reliever/fever reducer
Antihistamine/Cough suppressant
Nasal decongestant
Liver warnings: 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.
These could be signs of a serious condition.
ask a health professional before use.
Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. 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 as well as for children even if you do not notice any signs or symptoms.
acesulfame potassium, alcohol, citric acid, edetate disodium, FD&C blue #1, FD&C red #40, flavors, glycerin, maltitol, propylene glycol, purified water, sodium benzoate, sodium citrate
NIGHTTIME
Flu Relief Therapy
Severe Cold
Pain Reliever / Fever Reducer - Acetaminophen
Anthihistamine / Cough Suppressant - Diphenhydramine HCl
Nasal Decongestant - Phenylephrine HCl
•Aches • Fever • Sore Throat • Runny Nose • Sneezing • Cough • Itchy Nose or Throat • Itchy, Watery Eyes • Nasal Congestion
Alcohol Content: 10 %
Cherry Flavor
FL OZ (mL)
COMPARE TO THERAFLU® Nighttime Severe Cold & Cough active ingredients*
*This product is not manufactured or distributed by Novartis Consumer Healthcare, Inc., Distributor of Theraflu® Nighttime Severe Cold & Cough.
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND OR UNDER CAP IS BROKEN OR MISSING
DISTRIBUTED BY TOPCO ASSOCIATES LLC
ELK GROVE VILLAGE, IL 60007©TOPCO
QUESTIONS? 1-888-423-0139
* Please review the disclaimer below.