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  5. Label Information: Childrens Tylenol Cold Plus Cough Plus Runny Nose

FDA Label for Childrens Tylenol Cold Plus Cough Plus Runny Nose

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. OTC - PURPOSE
    3. USES
    4. LIVER WARNING
    5. DO NOT USE
    6. ASK A DOCTOR BEFORE USE IF YOUR CHILD HAS
    7. ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOUR CHILD IS
    8. WHEN USING THIS PRODUCT
    9. STOP USE AND ASK A DOCTOR IF
    10. OTC - KEEP OUT OF REACH OF CHILDREN
    11. OVERDOSE WARNING
    12. DIRECTIONS
    13. OTHER INFORMATION
    14. INACTIVE INGREDIENTS
    15. QUESTIONS OR COMMENTS?
    16. PRINCIPAL DISPLAY PANEL

Childrens Tylenol Cold Plus Cough Plus Runny Nose 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.

    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.


Otc - Purpose



Active ingredients (in each 5 mL)Purposes
Acetaminophen 160 mgPain reliever/fever reducer
Chlorpheniramine maleate 1 mgAntihistamine
Dextromethorphan HBr 5 mgCough suppressant

Uses



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

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 has ever had an allergic reaction to this product or any of its ingredients

Ask A Doctor Before Use If Your Child Has



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

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)
  • marked drowsiness may occur
  • sedatives and tranquilizers may increase drowsiness
  • excitability may occur, especially in children

Stop Use And Ask A Doctor If



  • pain or cough gets worse or lasts more than 5 days
  • fever gets worse or lasts more than 3 days
  • new symptoms occur
  • redness or swelling is present
  • 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)
    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 50580-245-01

Children's
TYLENOL®

COLD + COUGH +
RUNNY NOSE

Acetaminophen, Pain Reliever-Fever Reducer
Dextromethorphan HBr, Cough Suppressant
Chlorpheniramine Maleate, Antihistamine

Oral Suspension

Ages 6-11 Years

* Please review the disclaimer below.