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  5. Label Information: Childrens Tylenol Cold Plus Flu

FDA Label for Childrens Tylenol Cold Plus Flu

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 YOUR CHILD HAS
    8. ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOUR CHILD IS
    9. WHEN USING THIS PRODUCT
    10. STOP USE AND ASK A DOCTOR IF
    11. OTC - KEEP OUT OF REACH OF CHILDREN
    12. OVERDOSE WARNING
    13. DIRECTIONS
    14. OTHER INFORMATION
    15. INACTIVE INGREDIENTS
    16. QUESTIONS OR COMMENTS?
    17. PRINCIPAL DISPLAY PANEL

Childrens Tylenol Cold Plus Flu 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



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 5 mL)Purpose
Acetaminophen 160 mgPain reliever/fever reducer
Chlorpheniramine maleate 1 mgAntihistamine
Dextromethorphan HBr 5 mgCough suppressant
Phenylephrine HCl 2.5 mgNasal decongestant

Uses



  • temporarily relieves the following cold/flu symptoms:
    • minor aches and pains
    • headache
    • sore throat
    • cough
    • stuffy nose
    • sneezing and runny nose
    • temporarily reduces fever

Liver Warning



This product contains acetaminophen. Severe liver damage may occur if your child takes

  • more than 5 doses in 24 hours, which is the maximum daily amount
  • with other drugs containing acetaminophen

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



  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • to make a child sleepy
  • in a child who is 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 child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.
  • if your child is allergic to any of the ingredients in this product

Ask A Doctor Before Use If Your Child Has



  • liver disease
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • persistent or chronic cough such as occurs with asthma
  • cough that occurs with too much phlegm (mucus)
  • a breathing problem such as chronic bronchitis
  • glaucoma

Ask A Doctor Or Pharmacist Before Use If Your Child Is



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

When Using This Product



  • do not exceed recommended dose (see overdose warning)
  • excitability may occur, especially in children
  • marked drowsiness may occur
  • sedatives and tranquilizers may increase drowsiness

Stop Use And Ask A Doctor If



  • nervousness, dizziness or sleeplessness occur
  • pain, nasal congestion or cough gets worse or lasts more than 5 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 - 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.


Directions



  • this product does not contain directions or complete warnings for adult use.
  • do not give more than directed (see overdose warning)
  • shake well before using
  • mL = milliliter
  • find right dose on chart below. If possible, use weight to dose; otherwise, use age.
  • remove the child protective cap and squeeze your child's dose into the dosing cup
  • repeat dose every 4 hours while symptoms last
  • do not give more than 5 times in 24 hours
    • Weight (lb) Age (yr)Dose (mL)

    or as directed by a doctor

    under 36under 4 yearsdo not use
    36-474 to 5 yearsdo not use unless directed by a doctor
    48-956 to 11 years10 mL

    Attention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.


Other Information



  • store between 20-25°C (68-77°F)
  • do not use if carton is opened or if carton tape or bottle wrap imprinted "TYLENOL" is broken or missing

Inactive Ingredients



anhydrous citric acid, D&C red no. 33, FD&C blue no. 1, FD&C red no. 40, flavors, glycerin, microcrystalline cellulose and carboxymethylcellulose sodium, purified water, sodium benzoate, sorbitol solution, sucrose, xanthan gum


Questions Or Comments?



call 1-800-458-1635 (toll-free) or 215-273-8755 (collect)


Principal Display Panel



NDC 50580-299-01

Children's
TYLENOL®

COLD +
FLU

Acetaminophen, Pain Reliever-Fever Reducer
Chlorpheniramine Maleate, Antihistamine
Dextromethorphan HBr, Cough Suppressant
Phenylephrine HCl, Nasal Decongestant

Oral Suspension

Ages 6-11 Years

* Please review the disclaimer below.