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  5. Label Information: Theraflu Severe Cold Relief Daytime And Theraflu Severe Cold Relief Nighttime

FDA Label for Theraflu Severe Cold Relief Daytime And Theraflu Severe Cold Relief Nighttime

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENTS (IN EACH PACKET)
    2. PURPOSES
    3. USES
    4. WARNINGS
    5. DO NOT USE
    6. ASK A DOCTOR BEFORE USE IF YOU HAVE
    7. ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
    8. WHEN USING THIS PRODUCT
    9. STOP USE AND ASK A DOCTOR IF
    10. IF PREGNANT OR BREAST-FEEDING,
    11. KEEP OUT OF REACH OF CHILDREN.
    12. DIRECTIONS
    13. OTHER INFORMATION
    14. INACTIVE INGREDIENTS
    15. QUESTIONS OR COMMENTS?
    16. ADDITIONAL INFORMATION
    17. PRINCIPAL DISPLAY PANEL

Theraflu Severe Cold Relief Daytime And Theraflu Severe Cold Relief Nighttime 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
        • •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

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.

      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 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.
    • AgeDoseadults and children 12 years of age and overone packetchildren under 12 years of agedo not use
     
     
     
     
     
     
    • •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.
      • •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.
        • AgeDoseadults and children 12 years of age and overone packetchildren under 12 years of agedo not use
         
         
         
         
         
         
        • •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, soy lecithin, 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, soy lecithin, sucrose, tribasic calcium phosphate


Questions Or Comments?



call 1-855-328-5259

call 1-855-328-5259


Additional Information



DO NOT TAKE THE THERAFLU SEVERE COLD RELIEF DAYTIME AND THERAFLU SEVERE COLD RELIEF 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

©2022 GSK group of companies or its licensor.

Trademarks are owned by or licensed to the GSK group of companies.

READ ALL WARNINGS AND DIRECTIONS ON CARTON BEFORE USE.

KEEP CARTON FOR REFERENCE. DO NOT DISCARD.

DO NOT TAKE THE THERAFLU SEVERE COLD RELIEF DAYTIME AND THERAFLU SEVERE COLD RELIEF 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 SEVERE COLD RELIEF NIGHTTIME PRODUCT SOONER THAN 4 HOURS AFTER THE LAST DOSE OF SEVERE COLD RELIEF DAYTIME PRODUCT UNLESS DIRECTED BY YOUR DOCTOR.


Principal Display Panel



NDC 0067-6804-02

THERAFLU

SEVERE COLD RELIEF

COMBO PACK

6 x DAYTIME

Acetaminophen Pain Reliever/Fever Reducer

Dextromethorphan HBr Cough Suppressant

Phenylephrine HCl Nasal Decongestant

6 x NIGHTTIME

Acetaminophen Pain Reliever/Fever Reducer

Diphenhydramine HCl Antihistamine/Cough Suppressant

Phenylephrine HCl Nasal Decongestant

Hot liquid therapy that relieves:

Nasal and sinus congestion

Sore throat / Cough / Fever

Runny nose (Nighttime only)

6 DAYTIME PACKETS

6 NIGHTTIME PACKETS

12 TOTAL PACKETS

Honey Lemon

CM20326

THERAFLU

SEVERE COLD RELIEF

DAYTIME FORMULA

Acetaminophen

Pain Reliever/Fever Reducer

Dextromethorphan HBr

Cough Suppressant

Phenylephrine HCl

Nasal Decongestant

Hot liquid therapy that relieves:

Nasal and sinus congestion

Cough

Sore throat pain

Headache

Fever

Honey Lemon

6 PACKETS

62000000075408 – Front Carton

THERAFLU

SEVERE COLD RELIEF

NIGHTTIME

HELPS YOU REST

Acetaminophen

Pain Reliever/Fever Reducer

Diphenhydramine HCl

Antihistamine/Cough Suppressant

Phenylephrine HCl

Nasal Decongestant

Hot liquid therapy that relieves:

Nasal and sinus congestion

Cough

Sore throat pain

Headache

Runny nose

Fever

Honey Lemon

6 PACKETS

62000000075405 – Front Carton


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