THERAFLU POWERPODS NIGHTTIME SEVERE COLD ACETAMINOPHEN DIPHENHYDRAMINE HCL PHENYLEPHRINE HCL HALEON US HOLDINGS LLC FDA Approved 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
FunFoxMeds box
Substance Acetaminophen
Route
ORAL
Applications
M012

Drug Facts

Composition & Profile

Active Ingredients
Active ingredients (in each pod) Acetaminophen 650 mg Diphenhydramine HCl 25 mg Phenylephrine HCl 10 mg
Inactive Ingredients
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
Strengths
650 mg 25 mg 10 mg
Quantities
13020 count
Treats Conditions
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

Identifiers & Packaging

Container Type BOX
UNII
362O9ITL9D TC2D6JAD40 04JA59TNSJ
Packaging

Principal Display NDC 0067-6095-01 NEW THERAFLU POWERPODS NIGHTTIME SEVERE COLD ACETAMINOPHEN – PAIN RELIEVER/FEVER REDUCER DIPHENHYDRAMINE HCl – ANTIHISTAMINE/COUGH SUPPRESSANT PHENYLEPHRINE HCl – NASAL DECONGESTANT Nasal Congestion Sore Throat Pain Cough Headache Body Ache Fever Runny Nose Sneezing HONEY LEMONINFUSED WITH CHAMOMILE & WHITE TEA FLAVORS 8 PODS FOR USE ONLY WITH COMPATIBLE SINGLE SERVE BREWING MACHINES INCLUDING KEURIG AND MR. COFFEE* * This product is not affiliated with Keurig Incorporated or Mr. Coffee. READ ALL WARNINGS AND DIRECTIONS ON CARTON BEFORE USE. KEEP CARTON FOR REFERENCE. DO NOT DISCARD. TAMPER EVIDENT POUCH. PRODUCT IS PACKAGED IN INDIVIDUAL SEALED POUCHES. DO NOT USE IF POUCH IS TORN OR BROKEN. DO NOT OPEN POUCH UNTIL TIME OF USE. POWERFUL RELIEF FOR COLD SYMPTOMS PRESS Press the 8 oz. setting on your machine to brew. SIP Sip while hot. Consume entire drink within 10-15 minutes. Remove used pod and flush brewer after use with a minimum of 8 oz. of water. CAUTION: PRODUCT LIQUID AND POD WILL BE HOT. RELIEF Prepare to experience powerful cold & flu multi-symptom relief. 1-855-328-5259 Distributed by: GSK Consumer Healthcare, Warren, NJ 07059 ©2018 GSK group of companies or its licensor. Trademarks are owned by or licensed to the GSK group of companies. 13020 13020_Theraflu Powerpods Nighttime Severe Cold_8 pods.JPG

Package Descriptions
  • Principal Display NDC 0067-6095-01 NEW THERAFLU POWERPODS NIGHTTIME SEVERE COLD ACETAMINOPHEN – PAIN RELIEVER/FEVER REDUCER DIPHENHYDRAMINE HCl – ANTIHISTAMINE/COUGH SUPPRESSANT PHENYLEPHRINE HCl – NASAL DECONGESTANT Nasal Congestion Sore Throat Pain Cough Headache Body Ache Fever Runny Nose Sneezing HONEY LEMONINFUSED WITH CHAMOMILE & WHITE TEA FLAVORS 8 PODS FOR USE ONLY WITH COMPATIBLE SINGLE SERVE BREWING MACHINES INCLUDING KEURIG AND MR. COFFEE* * This product is not affiliated with Keurig Incorporated or Mr. Coffee. READ ALL WARNINGS AND DIRECTIONS ON CARTON BEFORE USE. KEEP CARTON FOR REFERENCE. DO NOT DISCARD. TAMPER EVIDENT POUCH. PRODUCT IS PACKAGED IN INDIVIDUAL SEALED POUCHES. DO NOT USE IF POUCH IS TORN OR BROKEN. DO NOT OPEN POUCH UNTIL TIME OF USE. POWERFUL RELIEF FOR COLD SYMPTOMS PRESS Press the 8 oz. setting on your machine to brew. SIP Sip while hot. Consume entire drink within 10-15 minutes. Remove used pod and flush brewer after use with a minimum of 8 oz. of water. CAUTION: PRODUCT LIQUID AND POD WILL BE HOT. RELIEF Prepare to experience powerful cold & flu multi-symptom relief. 1-855-328-5259 Distributed by: GSK Consumer Healthcare, Warren, NJ 07059 ©2018 GSK group of companies or its licensor. Trademarks are owned by or licensed to the GSK group of companies. 13020 13020_Theraflu Powerpods Nighttime Severe Cold_8 pods.JPG

Overview

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

Indications & Usage

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

Dosage & Administration

Directions do not use more than directed take every 4 hours, while symptoms persist. Do not take more than 5 pods in 24 hours unless directed by a doctor. Age Dose adults and children 12 years of age and over one pod children under 12 years of age do not use do not remove the foil seal as the pod will not work properly and could result in hot water burns place pod in compatible brewer use a minimum of 8 oz. of water when finished, the pod will be hot and may drip. Tilt the pod during removal to avoid dripping. remove used pod and flush brewer after each use with a minimum of 8 oz. of water sip while hot. Consume entire drink within 10-15 minutes.

Warnings & Precautions
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 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. 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 a 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 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 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 care 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.
Purpose

Purposes Pain reliever/Fever reducer Antihistamine/cough suppressant Nasal decongestant

Do Not Use

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 a 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.

When Using

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 & Ask a Doctor

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.

Keep Out of Reach of Children

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.

Storage & Handling

Other information each pod contains : potassium 10 mg, sodium 23 mg phenylketonurics : contains phenylalanine 13 mg per pod do not open pouch until time of use store at controlled room temperature 20°-25°C (68°-77°F). Protect product from heat and moisture.

Questions

Questions or comments? call 1-855-328-5259


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