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  5. Label Information: Tylenol Cold Plus Flu Severe Day And Tylenol Cold Plus Flu Plus Cough Night 3-pack

FDA Label for Tylenol Cold Plus Flu Severe Day And Tylenol Cold Plus Flu Plus Cough Night 3-pack

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. OTC - PURPOSE
    3. USES
    4. LIVER WARNING
    5. SORE THROAT WARNING
    6. DO NOT USE
    7. ASK A DOCTOR BEFORE USE IF YOU HAVE
    8. ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
    9. WHEN USING THIS PRODUCT
    10. STOP USE AND ASK A DOCTOR IF
    11. OTC - PREGNANCY OR BREAST FEEDING
    12. OTC - KEEP OUT OF REACH OF CHILDREN
    13. OVERDOSE WARNING
    14. DIRECTIONS
    15. OTHER INFORMATION
    16. INACTIVE INGREDIENTS
    17. QUESTIONS OR COMMENTS?
    18. OTC - ASK DOCTOR/PHARMACIST
    19. OTC - WHEN USING
    20. PRINCIPAL DISPLAY PANEL

Tylenol Cold Plus Flu Severe Day And Tylenol Cold Plus Flu Plus Cough Night 3-pack Product Label

The following document was submitted to the FDA by the labeler of this product Johnson & Johnson Consumer Inc.. 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.

Other



Tylenol® Cold plus Flu plus Cough
Night

Drug Facts

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.

    TYLENOL® Cold plus Flu Severe

    Drug Facts

    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.


Otc - Purpose



Active ingredients (in each 15 mL)Purpose
Acetaminophen 325 mgPain reliever/fever reducer
Dextromethorphan HBr 10 mgCough suppressant
Doxylamine Succinate 6.25 mgAntihistamine
Phenylephrine HCl 5 mgNasal decongestant
Active ingredients (in each 15 mL)Purpose
Acetaminophen 325 mgPain reliever/fever reducer
Dextromethorphan HBr 10 mgCough suppressant
Guaifenesin 200 mgExpectorant
Phenylephrine HCl 5 mgNasal decongestant

Uses



  • temporarily relieves these common cold/flu symptoms:
    • minor aches and pains
    • headache
    • sore throat
    • nasal congestion
    • runny nose and sneezing
    • cough
    • sinus congestion and pressure
    • helps clear nasal passages
    • relieves cough to help you sleep
    • temporarily reduces fever
      • temporarily relieves the following cold/flu symptoms:
        • minor aches and pains
        • headache
        • sore throat
        • nasal congestion
        • cough
        • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
        • 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 product

    • 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

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.

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



  • 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.
  • if you have ever had an allergic reaction to this product or any of its ingredients
    • 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.
    • if you have ever had an allergic reaction to this product or any of its ingredients

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
  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • persistent or chronic cough such as occurs with smoking, asthma or emphysema
  • cough that occurs with too much phlegm (mucus)
    • liver disease
    • heart disease
    • high blood pressure
    • thyroid disease
    • diabetes
    • trouble urinating due to an enlarged prostate gland
    • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
    • cough that occurs with too much phlegm (mucus)

Ask A Doctor Or Pharmacist Before Use If You Are



  • taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers

When Using This Product



  • do not exceed recommended dose
  • excitability may occur, especially in children
  • marked drowsiness may occur
  • alcohol, sedatives and tranquilizers may increase drowsiness
  • avoid alcoholic drinks
  • be careful when driving a motor vehicle or operating machinery

Stop Use And Ask A Doctor If



  • nervousness, dizziness, or sleeplessness occur
  • pain, nasal congestion or cough gets worse or lasts more than 7 days
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • new symptoms occur
  • cough comes back or occurs with rash or headache that lasts

    • These could be signs of a serious condition.

    • nervousness, dizziness, or sleeplessness occur
    • pain, nasal congestion or cough gets worse or lasts more than 7 days
    • fever gets worse or lasts more than 3 days
    • redness or swelling is present
    • new symptoms occur
    • cough comes back or occurs with rash or headache that lasts

      • These could be signs of a serious condition.


Otc - Pregnancy Or Breast Feeding



If pregnant or breast-feeding, ask a health professional before use.

If pregnant or breast-feeding, ask a health professional before use.


Otc - Keep Out Of Reach Of Children



Keep out of reach of children.

Keep out of reach of children.


Overdose Warning



In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) Quick 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. (1-800-222-1222) Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.


Directions



  • do not take more than directed (see overdose warning)
  • mL = milliliter
  • use only enclosed dosing cup designed for use with this product. Do not use any other dosing device.
    • adults and children 12 years and over
    • take 30 mL in the dosing cup provided every 4 hours while symptoms last
    • do not take more than 150 mL in 24 hours, unless directed by a doctor
    children under 12 yearsask a doctor
    • do not take more than directed (see overdose warning)
    • mL = milliliter
    • use only enclosed dosing cup designed for use with this product. Do not use any other dosing device.
      • adults and children 12 years and over
      • take 30 mL in the dosing cup provided every 4 hours while symptoms last
      • do not take more than 150 mL in 24 hours, unless directed by a doctor
      children under 12 yearsask a doctor

Other Information



  • each 15 mL contains: sodium 5 mg
  • store between 20-25°C (68-77°F). Do not refrigerate.
  • do not use if neck band imprinted with "TYLENOL COLD+FLU+COUGH" or foil inner seal imprinted with "SAFETY SEAL®" is broken or missing
    • each 15 mL contains: sodium 5 mg
    • store between 20-25°C (68-77°F). Do not refrigerate.
    • do not use if neck band imprinted with "TYLENOL COLD + FLU SEVERE" or foil inner seal imprinted with "SAFETY SEAL®" is broken or missing

Inactive Ingredients



acetic acid, alcohol, anhydrous citric acid, FD&C blue no. 1, FD&C red no. 40, flavors, glycerin, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose

anhydrous citric acid, FD&C blue no. 1, FD&C red no. 40, FD&C yellow no. 6, flavors, glycerin, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose


Questions Or Comments?



call 1-877-895-3665 (toll-free) or 215-273-8755 (collect)

call 1-877-895-3665 (toll-free) or 215-273-8755 (collect)


Otc - Ask Doctor/Pharmacist



Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin


Otc - When Using



When using this product do not exceed recommended dose


Principal Display Panel



NDC 50580-529-01

DAYTIME

DAYTIME

NIGHTTIME

Principal Display Panel - tylenol 01

Principal Display Panel - tylenol 01

30040371
NDC 50580-369-01

TYLENOL®
FOR ADULTS
COLD + FLU + COUGH

Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate, Phenylephrine HCl,
Pain Reliever–Fever Reducer, Cough Suppressant, Antihistamine, Nasal Decongestant

  • HEAD + BODY ACHES
  • FEVER + SORE THROAT
  • COUGH
  • NASAL CONGESTION
  • RUNNY NOSE

    • NIGHT

    WILD BERRY
    BURST

    Alcohol 0.7%
    8 fl oz (240 mL)

    30038514
    NDC 50580-403-08

    TYLENOL®
    FOR ADULTS

    COLD + FLU SEVERE

    Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl, Guaifenesin
    Pain Reliever–Fever Reducer, Cough Suppressant, Nasal Decongestant, Expectorant

    • HEAD + BODY ACHES
    • FEVER + SORE THROAT
    • COUGH
    • NASAL CONGESTION
    • MUCUS + CHEST CONGESTION

      • DAY
      NON-DROWSY

      Warming
      HONEY
      LEMON

      8 fl oz (240 mL)


* Please review the disclaimer below.