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  5. Label Information: Dye Freeinfants Pain And Fever

FDA Label for Dye Freeinfants Pain And Fever

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. ACTIVE INGREDIENT (IN EACH 5 ML)
    3. PURPOSE
    4. USES
    5. LIVER WARNING
    6. DO NOT USE
    7. OTC - ASK DOCTOR
    8. OTC - ASK DOCTOR/PHARMACIST
    9. OTC - WHEN USING
    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?
    17. PRINCIPAL DISPLAY PANEL

Dye Freeinfants Pain And Fever Product Label

The following document was submitted to the FDA by the labeler of this product Walgreen Company. 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.

    Attention: use only enclosed syringe specifically designed for use with this product.

    Do not use any other dosing device.


Active Ingredient (In Each 5 Ml)



Acetaminophen 160 mg


Purpose



Pain reliever/fever reducer


Uses



temporarily:

  • ▪reduces fever
  • ▪relieves minor aches and pains due to:
    • ▪the common cold
    • ▪flu
    • ▪headache
    • ▪sore throat
    • ▪toothache

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.
  • •if your child is allergic to acetaminophen or any of the inactive ingredients in this product

Otc - Ask Doctor



Ask a doctor before use if your child has liver disease


Otc - Ask Doctor/Pharmacist



Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin


Otc - When Using



When using this product do not exceed recommended dose (see overdose warning)


Stop Use And Ask A Doctor If



  • ▪pain 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

    • 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 (seeoverdose warning)
  • ▪shake well before using
  • ▪mL = milliliter
  • ▪find right dose on chart. If possible, use weight to dose; otherwise, use age.
  • ▪push air out of syringe. Insert syringe tip into bottle opening
  • ▪flip bottle upside down. Pull yellow part of syringe to correct dose
  • ▪dispense liquid slowly into child's mouth, toward inner cheek
  • ▪repeat dose every 4 hours while symptoms last
  • ▪do not give more than 5 times in 24 hours
  • ▪replace cap tightly to maintain child resistance
    • mL
    Dosing Chart
    Weight (lb)Age (yr)Dose (mL) **

    under 24

    under 2 years

    ask a doctor

    24-35 lbs

    2-3 years

    5

Other Information



  • ▪store at room temperature
  • ▪Each 5 mL contains: sodium 2 mg

Inactive Ingredients



anhydrous citric acid, carboxymethylcellulose sodium, flavors, glycerin, microcrystalline cellulose, sodium benzoate, purified water, sodium citrate dihydrate, sorbitol liquid, sucralose, xanthan gum


Questions?



1-866-467-2748


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