FDA Label for Theraflu Multi-symptom Severe Cold And Theraflu Nighttime Severe Cold And Cough
View Indications, Usage & Precautions
- 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
- STOP USE AND ASK A DOCTOR IF
- IF PREGNANT OR BREAST-FEEDING,
- KEEP OUT OF REACH OF CHILDREN.
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- PRINCIPAL DISPLAY PANEL
Theraflu Multi-symptom Severe Cold And Theraflu Nighttime Severe Cold And Cough Product Label
The following document was submitted to the FDA by the labeler of this product Haleon Us Holdings Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredients (In Each Packet)
Acetaminophen 500 mg
Dextromethorphan HBr 20 mg
Phenylephrine HCl 10 mg
Acetaminophen 650 mg
Diphenhydramine HCl 25 mg
Phenylephrine HCl 10 mg
Purposes
Pain Reliever/fever reducer
Cough suppressant
Nasal decongestant
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• cough due to minor throat and bronchial irritation• temporarily reduces fever• temporarily relieves these symptoms due to a cold:• minor aches and pains• headache• runny nose• itchy nose or throat• cough due to minor throat and bronchial irritation• minor sore throat pain• nasal and sinus congestion• sneezing• itchy watery eyes due to hay fever
• 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• 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:
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.
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.
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.• 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
Ask A Doctor Before Use If You Have
• liver disease• heart disease• high blood pressure• thyroid disease• diabetes• trouble urinating due to an enlarged prostate gland• cough that occurs with too much phlegm (mucus)• cough that lasts or is chronic such as occurs with smoking, asthma or emphysema• 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 the blood thinning drug warfarin• taking sedatives or tranquilizers• taking the blood thinning drug warfarin
When Using This Product
• do not exceed recommended dosage• 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 lasts more than 7 days• cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.• 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 lasts 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.
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.
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.• 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.• 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.
Other Information
• each packet contains: potassium 10 mg, sodium 19 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.
Inactive Ingredients
acesulfame potassium, anhydrous citric acid, aspartame, D&C yellow no. 10, FD&C blue no.1, FD&C red no. 40, flavors, maltodextrin, silicon dioxide, sodium citrate, 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, flavors, maltodextrin, silicon dioxide, sodium citrate, sucrose, tribasic calcium phosphate
Questions Or Comments?
call 1-855-328-5259
Call 1-855-328-5259
Principal Display Panel
THERAFLU
MULTI-SYMPTOM SEVERE COLD
ACETAMINOPHEN – PAIN RELIEVER/FEVER REDUCER
DEXTROMETHORPHAN HBr – COUGH SUPPRESSANT
PHENYLEPHRINE HCl – NASAL DECONGESTANT
• NASAL CONGESTION• SORE THROAT PAIN• COUGH• HEADACHE• BODY ACHE• FEVER• NASAL CONGESTION• SORE THROAT PAIN• COUGH• HEADACHE• BODY ACHE• FEVER• RUNNY NOSE• SNEEZING
TEA INFUSIONS
GREEN TEA & HONEY LEMON FLAVORS
6 MULTI-SYMPTOM PACKETS
NIGHTTIME SEVERE COLD & COUGH
ACETAMINOPHEN – PAIN RELIEVER/FEVER REDUCER
DIPHENHYDRAMINE HCl - ANTIHISTAMINE/COUGH SUPRESSSANT
PHENYLEPHRINE HCl – NASAL DECONGESTANT
Honey Lemon, Chamomile & White Tea Flavors
6 NIGHTTIME PACKETS
12 TOTAL PACKETS
READ ALL WARNINGS AND DIRECTIONS ON CARTON BEFORE USE. KEEP CARTON FOR REFERENCE. DO NOT DISCARD.
DO NOT TAKE THE MULTI-SYMPTOM AND 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 NIGHTTIME PRODUCT SOONER THAN 4 HOURS AFTER THE LAST DOSE OF MULTI-SYMPTOM PRODUCT UNLESS DIRECTED BY YOUR DOCTOR.
DO NOT TAKE THE MULTI-SYMPTOM AND 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
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
©2017 GSK group of companies or its licensor.
13215
* Please review the disclaimer below.