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  5. Label Information: Childrens Pain Relief Cold And Cough And Sore Throat

FDA Label for Childrens Pain Relief Cold And Cough And Sore Throat

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENTS (IN EACH 5 ML)
    2. PURPOSES
    3. USES
    4. WARNINGS
    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. KEEP OUT OF REACH OF CHILDREN.
    11. DIRECTIONS
    12. OTHER INFORMATION
    13. INACTIVE INGREDIENTS
    14. QUESTIONS OR COMMENTS?
    15. PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

Childrens Pain Relief Cold And Cough And Sore Throat Product Label

The following document was submitted to the FDA by the labeler of this product Rite Aid Corporation. 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 5 Ml)



Acetaminophen 160 mg

Dextromethorphan HBr 5 mg


Purposes



Pain reliever/fever reducer

Cough suppressant


Uses



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

Warnings



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

    • 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



  • •with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • •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
  • •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


When Using This Product



  • •do not exceed recommended dosage (see overdose warning)

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.

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 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 36

    under 4 years

    do not use

    36-47

    4 to 5 years

    5 mL

    48-95

    6 to 11 years

    10 mL

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


Other Information



  • •each 5 mL contains: sodium 3 mg
  • •store at 20-25°C (68-77°F)
  • •do not use if printed neckband is broken or missing

Inactive Ingredients



anhydrous citric acid, calcium sulfate, carrageenan, D&C red #33, edetate disodium, FD&C red #40, flavor, glycerin, polysorbate 80, purified water, sodium benzoate, sorbitol solution, sucrose, tribasic sodium phosphate, xanthan gum


Questions Or Comments?



1-800-719-9260


Package/Label Principal Display Panel



Compare to the active ingredients of Children’s Tylenol® Cold + Cough + Sore Throat Oral Suspension

children’s pain relief cold & cough & sore throat

fever & sore throat (acetaminophen)

cough (dextromethorphan HBr)

pain reliever/fever reducer

cough suppressant

oral suspension

alcohol free

aspirin free

bubble gum flavor

ibuprofen free

gluten-free

for ages 4-11 years

dosage cup included

4 FL OZ (118 mL)


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