Active Ingredients (In Each Packet) (Daytime)
Acetaminophen 500 mg
Dextromethorphan HBr 20 mg
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 0067-0101). 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) (daytime), purposes (daytime), active ingredients (in each packet) (nighttime), purposes (nighttime), uses (daytime), uses (nighttime), warnings (daytime), do not use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Acetaminophen 500 mg
Dextromethorphan HBr 20 mg
Pain reliever/Fever reducer
Cough suppressant
Acetaminophen 650 mg
Diphenhydramine HCl 25 mg
Pain reliever/Fever reducer
Antihistamine/Cough suppressant
• temporarily relieves these symptoms due to a cold:
• temporarily reduces fever
• temporarily relieves these symptoms due to a cold:
• temporarily reduces fever
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
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.
• 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.
• 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.
• 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.
• liver disease
• cough that occurs with too much phlegm (mucus)
• cough that lasts or is chronic such as occurs with smoking, asthma or emphysema
• liver disease • 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
• taking the blood thinning drug warfarin
• taking sedatives or tranquilizers
• taking the blood thinning drug warfarin
• fever gets worse or lasts more than 3 days
• redness or swelling is present
• new symptoms occur
• pain or cough gets worse or lasts more than 7 days
• cough comes back or occurs with rash or headache that lasts
These could be signs of a serious condition.
• fever gets worse or lasts more than 3 days • redness or swelling is present
• new symptoms occur • cough comes back or occurs with rash or headache that lasts
• pain or cough gets worse or lasts more than 7 days
These could be signs of a serious condition.
ask a health professional before use.
ask a health 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.
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.
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
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.
• 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
• 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.
Age | Dose |
adults and children 12 years of age and over | one packet |
children under 12 years of age | do not use |
• dissolve contents of one packet into 8 oz. hot water; sip while hot. Consume 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.
• do not use more than directed
• take every 4 hours, while symptoms persist. Do not take more than 5 packets in 24 hours unless directed by a doctor.
Age | Dose |
adults and children 12 years of age and over | one packet |
children under 12 years of age | do not use |
• dissolve contents of one packet into 8 oz. hot water; sip while hot. Consume 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.
• each packet contains: potassium 10 mg, sodium 20 mg
• phenylketonurics: contains phenylalanine 20 mg per packet
• store at controlled room temperature 20-25°C (68-77°F). Protect product from heat and moisture.
• 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.
acesulfame potassium, anhydrous citric acid, aspartame, D&C yellow no. 10, FD&C blue no. 1, FD&C red no. 40, maltodextrin, natural and artificial flavors, silicon dioxide, sodium citrate, soy lecithin, sucrose, tribasic calcium phosphate
acesulfame potassium, anhydrous citric acid, aspartame, D&C yellow no. 10, FD&C blue no. 1, FD&C red no. 40, maltodextrin, natural and artificial flavors, silicon dioxide, sodium citrate, soy lecithin, sucrose, tribasic calcium phosphate
1-855-328-5259
1-855-328-5259
DO NOT TAKE THE THERAFLU SEVERE COLD RELIEF DAYTIME AND THERAFLU
SEVERE COLD RELIEF NIGHTTIME PRODUCTS AT THE SAME TIME.
DO NOT TAKE MORE THAN 5 DOSES IN TOTAL IN ANY 24 HOUR PERIOD.
PARENTS:
Learn about teen medicine abuse
www.StopMedicineAbuse.org
READ ALL WARNINGS AND DIRECTIONS ON CARTON BEFORE USE.
KEEP CARTON FOR REFERENCE. DO NOT DISCARD.
DO NOT TAKE THE THERAFLU SEVERE COLD RELIEF DAYTIME AND THERAFLU
SEVERE COLD RELIEF NIGHTTIME PRODUCTS AT THE SAME TIME.
DO NOT TAKE MORE THAN 5 DOSES IN TOTAL IN ANY 24 HOUR PERIOD.
DO NOT TAKE A DOSE OF THE SEVERE COLD RELIEF NIGHTTIME PRODUCT
SOONER THAN 4 HOURS AFTER THE LAST DOSE OF SEVERE COLD RELIEF
DAYTIME PRODUCT UNLESS DIRECTED BY YOUR DOCTOR.
TAMPER EVIDENT INNER UNIT
DO NOT USE IF SEALED THERAFLU PACKET IS TORN OR BROKEN
1-855-328-5259
Distributed by: Haleon, Warren, NJ 07059
©2023 Haleon group of companies or its licensor.
Trademarks are owned by or licensed to the Haleon group of companies.
Pat. Info www.productpats.com
207735
MULTI-SYMPTOM COLD RELIEF
NEW FORMULA
THERAFLU
SEVERE
COLD RELIEF
MULTI-SYMPTOM COLD RELIEF
Hot liquid therapy that relieves:
/Cough /Sore throat pain /Head and body ache
/Fever /Runny nose (Nighttime only)
/Sneezing (Nighttime only)
Honey Lemon Flavor
USE AS DIRECTED
DAYTIME
Acetaminophen Pain Reliever/Fever Reducer
Dextromethorphan HBr Cough suppressant
NIGHTTIME
Acetaminophen Pain Reliever/Fever Reducer
Diphenhydramine HCl Antihistamine/Cough Suppressant
DAYTIME
18 PACKETS
24 TOTAL PACKETS
NIGHTTIME
6 PACKETS
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