Active Ingredients (In Each Packet)
Acetaminophen 650 mg
Diphenhydramine HCl 25 mg
Phenylephrine HCl 10 mg
The following Structured Product Label (SPL) was submitted to the FDA by Haleon Us Holdings Llc for the product Theraflu (NDC 0067-8212). 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 packet), purposes, uses, warnings, do not use, ask 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 650 mg
Diphenhydramine HCl 25 mg
Phenylephrine HCl 10 mg
Pain reliever/Fever reducer
Antihistamine/Cough suppressant
Nasal decongestant
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.
ask a health care professional before use.
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.
Age | Dose |
adults and children | one packet |
children under 12 years of age | do not use |
acesulfame potassium, acetic acid, aspartame, citric acid, elderberry juice concentrate, FD&C blue no. 1, FD&C red no. 40, honey solids, isomalt, maltodextrin, natural flavors, silicon dioxide, sodium citrate, soy lecithin, sucrose, sunflower lecithin, triacetin, tribasic calcium phosphate
1-855-328-5259
READ ALL WARNINGS AND DIRECTIONS ON CARTON BEFORE USE.
KEEP CARTON FOR REFERENCE. DO NOT DISCARD.
TAMPER EVIDENT INNER UNIT
DO NOT USE IF SEALED THERAFLU PACKET IS TORN OR BROKEN
1-855-328-5259
Distributed by: GSK Consumer Healthcare
Warren, NJ 07059
©2022 GSK group of companies or its licensor.
Trademarks are owned by or licensed to the GSK group of companies.
THERAFLU
NEW FLAVOR
MULTI - SYMPTOM COLD RELIEF
SEVERECOLD RELIEF
NIGHTTIME
HELPS YOU REST
Acetaminophen
Pain Reliever/Fever Reducer
Diphenhydramine HCl
Antihistamine/Cough Suppressant
Phenylephrine HCl
Nasal Decongestant
Hot liquid therapy
that relieves:
/ Nasal and sinus congestion
/ Cough
/ Sore throat pain
/ Headache
/ Runny nose
/ Fever
Honey Elderberry
6 PACKETS
PA 62000000200565 – Carton Front
* Please review the disclaimer below.