FDA Label for Theraflu Powerpods Daytime Severe Cold
View Indications, Usage & Precautions
- ACTIVE INGREDIENTS (IN EACH POD)
- PURPOSES
- USES
- WARNINGS
- DO NOT USE
- ASK 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
Theraflu Powerpods Daytime Severe Cold 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 Pod)
Acetaminophen 650 mg
Dextromethorphan HBr 20 mg
Phenylephrine HCl 10 mg
Purposes
Pain reliever/Fever reducer
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
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:
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.
Ask 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
Ask A Doctor Or Pharmacist Before Use If You Are
• taking the blood thinning drug warfarin
When Using This Product
• do not exceed recommended dosage
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 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 5 pods in 24 hours unless directed by a doctor.• 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 use with a minimum of 8 oz. of water• sip while hot. Consume entire drink within 10-15 minutes.
Age | Dose |
adults and children 12 years of age and over | one pod |
children under 12 years of age | do not use |
Other Information
• each pod contains: potassium 10 mg, sodium 20 mg• phenylketonurics: contains phenylalanine 14 mg per pod• do not open pouch until time of use• store at controlled room temperature 20o-25oC (68o-77oF). Protect product from heat and moisture.
Inactive Ingredients
acesulfame potassium, anhydrous citric acid, aspartame, 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
Principal Display
NDC 0067-6094-01
NEW
THERAFLU
POWERPODS
DAYTIME
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
BERRY INFUSED WITH MENTHOL & GREEN 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.
PARENTS:
Learn about teen medicine abuse
www.StopMedicineAbuse.org
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.
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* Please review the disclaimer below.