Drug Facts

Drug Facts
SPL v7
SPL
SPL Set ID 39f9feef-4bf2-4f10-9fff-22bbb1d8a471
Route
ORAL
Published
Effective Date 2024-01-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (650 mg) Diphenhydramine (25 mg) Phenylephrine (10 mg)
Inactive Ingredients
Acesulfame Potassium Anhydrous Citric Acid Aspartame D&c Yellow No. 10 Fd&c Blue No. 1 Fd&c Red No. 40 Maltodextrin Silicon Dioxide Sodium Citrate, Unspecified Form Sucrose Tribasic Calcium Phosphate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2018-07-28

Description

Acetaminophen 650 mg Diphenhydramine HCl 25 mg Phenylephrine HCl 10 mg

Purpose

Pain reliever/Fever reducer Antihistamine/cough suppressant Nasal decongestant


Medication Information

Purpose

Pain reliever/Fever reducer Antihistamine/cough suppressant Nasal decongestant

Description

Acetaminophen 650 mg Diphenhydramine HCl 25 mg Phenylephrine HCl 10 mg

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
Purposes

Pain reliever/Fever reducer

Antihistamine/cough suppressant

Nasal decongestant

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.

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.
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.
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.
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

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

Questions Or Comments?

call 1-855-328-5259

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.

Active Ingredients (in Each Pod)

Acetaminophen 650 mg

Diphenhydramine HCl 25 mg

Phenylephrine HCl 10 mg

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

Structured Label Content

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
Purposes

Pain reliever/Fever reducer

Antihistamine/cough suppressant

Nasal decongestant

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.

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.
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.
Other Information (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.
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

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

Questions Or Comments? (Questions or comments?)

call 1-855-328-5259

When Using This Product (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 (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, (If pregnant or breast-feeding,)

ask a health care professional before use.

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.

Active Ingredients (in Each Pod) (Active ingredients (in each pod))

Acetaminophen 650 mg

Diphenhydramine HCl 25 mg

Phenylephrine HCl 10 mg

Ask Doctor Before Use If You Have (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 (Ask a doctor or pharmacist before use if you are)
  • taking sedatives or tranquilizers
  • taking the blood thinning drug warfarin

Advanced Ingredient Data


Raw Label Data

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