Active Ingredients (In Each Packet)
Acetaminophen 500 mg
Diphenhydramine HCl 25 mg
Phenylephrine HCl 10 mg
Theraflu Severe Cold Relief Nighttime Powder
FDA Label NDC 0067-6801
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Haleon Us Holdings Llc for the product Theraflu Severe Cold Relief Nighttime (NDC 0067-6801). 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 a 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.
Label Section Quick Index
Purposes
Pain reliever/Fever reducer
Antihistamine/cough suppressant
Nasal decongestant
Uses
- temporarily relieves these symptoms due to a cold:
- minor aches and pains
- minor sore throat pain
- headache
- nasal and sinus congestion
- runny nose
- sneezing
- itchy nose or throat
- itchy, watery eyes due to hay fever
- cough due to minor throat and bronchial irritation
- temporarily reduces fever
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
- more than 4,000 mg of acetaminophen in 24 hours
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks every day while using this product
- skin reddening
- blisters
- rash
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
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
- in a child under 12 years of age
- if you are allergic to acetaminophen
- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
- with any other product containing diphenhydramine, even one used on the skin
- if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
Ask A Doctor Before Use If You Have
- liver disease
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- glaucoma
- trouble urinating due to an enlarged prostate gland
- a breathing problem such as emphysema or chronic bronchitis
- cough that occurs with too much phlegm (mucus)
- cough that lasts or is chronic such as occurs with smoking, asthma or emphysema
Ask A Doctor Or Pharmacist Before Use If You Are
- taking sedatives or tranquilizers
- taking the blood thinning drug warfarin
When Using This Product
- do not exceed recommended dosage
- avoid alcoholic drinks
- marked drowsiness may occur
- alcohol, sedatives and tranquilizers may increase drowsiness
- be careful when driving a motor vehicle or operating machinery
- excitability may occur, especially in children
Stop Use And Ask A Doctor If
- nervousness, dizziness, or sleeplessness occurs
- fever gets worse or lasts more than 3 days
- redness or swelling is present
- new symptoms occur
- pain, cough or nasal congestion gets worse or last more than 7 days
- cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.
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 right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Directions
- do not use more than directed
- take every 4 hours, while symptoms persist. Do not take more than 6 packets in 24 hours unless directed by a doctor
- dissolve contents of one packet into 8 oz. hot water; sip while hot. Consumer entire drink within 10-15 minutes.
- if using a microwave, add contents of one packet to 8 oz. of cool water; stir briskly before and after heating. Do not overheat.
Other Information
- each packet contains: potassium 10 mg, sodium 23 mg
- phenylketonurics: contains phenylalanine 13 mg per packet
- store at controlled room temperature 20-25°C (68-77°F). Protect product from heat and moisture.
Inactive Ingredients
acesulfame potassium, anhydrous citric acid, aspartame, FD&C yellow no. 6, flavors, maltodextrin, silicon dioxide, sodium citrate, soy lecithin, sucrose, tribasic calcium phosphate
Questions Or Comments?
call 1-800-328-5259
Generic Section
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. 62000000075407
HOT LIQUID THERAPY
that relieves:
Nasal and sinus congestion Cough
Sore throat pain Headache
Runny nose Fever
PARENTS:
Learn about teen medicine abuse
www.StopMedicineAbuse.com
*Temporarily controls cough to help you rest. This is not a sleep aid
CARTON
RECYCLE
Principal Display Panel
NDC 0067-6801-02
MULTI-SYMPTOM COLD RELIEF
THERAFLU
SEVERE
COLD RELIEF
NIGHTTIME
ACETAMINOPHEN
PAIN RELIEVER/FEVER REDUCER
DIPHENHYDRAMINE HCl
ANTIHISTAMINE/COUGH SUPPRESSANT
PHENYLEPHRINE HCl
NASAL DECONGESTANT
HELPS YOU REST*
Hot liquid therapy
that relieves:
/ Nasal and sinus congestion
/ Cough
/ Sore throat pain
/ Headache
/ Runny nose
/ Fever
Citrus & Green Tea
6 PACKETS
* Please review the disclaimer below.
