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  5. Label Information: Childrens Pain Relief

FDA Label for Childrens Pain Relief

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT (IN EACH TABLET)
    2. PURPOSE
    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. PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 160 MG (24 CHEWABLE TABLETS)

Childrens Pain Relief Product Label

The following document was submitted to the FDA by the labeler of this product Aurohealth Llc. 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 Ingredient (In Each Tablet)



Acetaminophen USP 160 mg


Purpose



Pain reliever/fever reducer


Uses




  • temporarily relieves minor aches and pains due to:
    • the common cold
    • flu
    • headache
    • sore throat
    • toothache
    • 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.
  •  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 dosage.


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.


Keep Out Of Reach Of Children.



Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt 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)
  • find right dose on chart below. If possible, use weight to dose; otherwise, use age
  • chew before swallowing; this product will soften in mouth for ease of chewing
  • repeat dose every 4 hours while symptoms last
  • do not give more than 5 times in 24 hours

    • Weight (lb)
    		Age (yr)
    		Dose (tablets)*
    * or as directed by a doctor
    under 24
    		under 2 years
    		ask a doctor
    24-35
    		2-3 years
    		1 tablet
    36-47
    		4-5 years
    		1½ tablets
    48-59
    		6-8 years
    		2 tablets
    60-71
    		9-10 years
    		2½ tablets
    72-95
    		11 years
    		3 tablets


Other Information




  • store at 20° to 25°C (68° to 77°F). Avoid high humidity.
  • Tamper Evident: Do not use if carton is open or if printed seal on blister is broken or missing.

Inactive Ingredients



citric acid anhydrous, colloidal silicon dioxide, copovidone, crospovidone, D&C red No.27 lake, D&C red 30 aluminum lake, dextrose monohydrate, ethylcellulose, FD &C Blue No.1 lake, flavor, magnesium stearate, mannitol, sodium starch glycolate, stearic acid, sucralose.


Questions or comments?

Call 1-855-274-4122


* This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Children's Tylenol® Chewables.

DO NOT USE WITH OTHER MEDICINES CONTAINING ACETAMINOPHEN

Distributed by:
AUROHEALTH LLC
2572 Brunswick Pike
Lawrenceville, NJ 08648


Package Label-Principal Display Panel - 160 Mg (24 Chewable Tablets)



AUROHEALTH
NDC 58602-765-76
Ages 2-11
Children's Pain Relief
Acetaminophen 160 mg
Pain reliever/Fever reducer
 

* Please review the disclaimer below.