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  5. Label Information: Acetaminophen

FDA Label for Acetaminophen

View Indications, Usage & Precautions

Table of Contents

    1. DRUG FACTS
    2. ACTIVE INGREDIENT (IN EACH 5ML)
    3. PURPOSE
    4. USES
    5. WARNINGS
    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 DO NOT EXCEED RECOMMENDED DOSE
    10. STOP USE AND ASK A DOCTOR IF
    11. OVERDOSE WARNING:
    12. DIRECTIONS
    13. OTHER INFORMATION
    14. INACTIVE INGREDIENTS
    15. QUESTIONS OR COMMENTS?
    16. INFANT'S ACETAMINOPHEN ORAL SUSPENSIONPAIN RELIEVER/ FEVER REDUCER

Acetaminophen Product Label

The following document was submitted to the FDA by the labeler of this product Healthlife Of Usa. 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.

Drug Facts




Active Ingredient (In Each 5Ml)



Acetaminophen 160mg


Purpose



Fever reducer/ pain reliever


Uses



Temporarily:

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

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 

    • 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.

    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.


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

Ask A Doctor Before Use If Your Child Has



liver disease


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 Dose



(See overdose warning)


Stop Use And Ask A Doctor If



  • new symptoms occur
  • redness or swelling is present
  • pain gets worse or lasts more than 5 days
  • fever gets worse or lasts more than 3 days

    • These could be signs of a serious condition


Overdose Warning:



In case of overdose, get medical help or contact a Poison Control Center right away. 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
  • mL=mililiter
  • find right dose on chart below. If possible, use weight to dose; otherwise, use age.
  • fill to dose level. Do not use any other dosing device
  • dispense liquid slowly into child's mouth, toward inner cheek
  • repeat dose every 4 hours while symptoms last
  • rinse the dosing device after each use
  • do not give more than 5 times in 24 hours
  • shake well before use
  • do not give moer than directed.
    • Weight (lb)Age (year)Dose (mL)*
    Under 24Under 2 years Ask a doctor
    24-352-35mL

    * or as directed by a doctor

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


Other Information



  • Store between 15°-30°C (59°-86°F)
  • Protect from freezing
  • Protect from light

Inactive Ingredients



Acesulfame Potassium, Avicel, Butyl paraben, citric acid, FD&C Red #40, Glycerin, High fructose corn syrup, Nat grape flavor, polysorbate 80, propylene glycol, sodium benzoate, sorbitol, sucralose, Prosweet N and A, Purified water, xanthan gum


Questions Or Comments?



Call 1-844-832-1138


Infant's Acetaminophen Oral Suspensionpain Reliever/ Fever Reducer



Distributed by:

Healthlife of USA

1600 Hart Street,

Rahway, NJ 07065

www.healthlifeofusa.com


* Please review the disclaimer below.