The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.
Active Ingredients (In Each Pod)
Acetaminophen 650 mgDiphenhydramine HCl 25 mgPhenylephrine HCl 10 mg
Pain reliever/Fever reducerAntihistamine/cough suppressantNasal decongestant
- •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
- 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 productAllergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include: •skin reddening •blisters •rashIf 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.
- •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.AgeDoseadults and children 12 years of age and overone podchildren under 12 years of agedo 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.
- •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.
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
- NDC 0067-6095-01NEWTHERAFLUPOWERPODSNIGHTTIMESEVERE COLDACETAMINOPHEN – PAIN RELIEVER/FEVER REDUCERDIPHENHYDRAMINE HCl – ANTIHISTAMINE/COUGH SUPPRESSANTPHENYLEPHRINE HCl – NASAL DECONGESTANT •Nasal Congestion •Sore Throat Pain •Cough •Headache •Body Ache •Fever •Runny Nose •SneezingHONEY LEMONINFUSED WITH CHAMOMILE & WHITE TEA FLAVORS8 PODSFOR 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 SYMPTOMSPRESSPress the 8 oz. setting on your machine to brew.SIPSip 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.RELIEFPrepare to experience powerful cold & flu multi-symptom relief. 1-855-328-5259Distributed 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
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