Childrens Non Aspirin
FDA Label NDC 67510-0508

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Kareway Product, Inc. for the product Childrens Non Aspirin (NDC 67510-0508). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient (in each 5 ml = 1 teaspoon), purpose, uses, warnings, do not use, stop use and ask a doctor if, keep out of reach of children., overdose warning:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient (In Each 5 Ml = 1 Teaspoon)


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

Warnings

Sore throat warning: If sore throat is severe, persists for more than 2 days, occurs with or is followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Do Not Use

  • with any other product containing acetaminophen

Stop Use And Ask A Doctor If

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

Keep Out Of Reach Of Children.

Enter section text here

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. Quick medical attention is critical even if you do not notice any signs or symptoms.

Directions

do not give more than directed (see overdose warning)
  • shake well before using
  • find right dose on chart below. If possible use weight to dose; otherwise, use age.
  • if needed, repeat dose every 4 hours
  • do not give more than 5 times in 24 hours
    • Weight (lb)
    		Age (yr)
    		Dose (tsp or mL)
    under 24
    		under 2
    		ask a doctor
    24-35
    		2-3
    		1 tsp or 5 mL
    36-47
    		4-5
    		1 1/2 tsp or 7.5 mL
    48-59
    		6-8
    		2 tsp or 10 mL
    60-71
    		9-10
    		2 1/2 tsp or 12.5 mL
    72-95
    		11
    		3 tsp or 15 mL
    Attention:use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.

Other Information

  • each teaspoon contains: sodium 1 mg
  • do not use if bottle wrap, or foil inner seal imprinted "SEALED for YOUR PROTECTION" is broken or missing
  • store between 20-25°C (68-77°F)
  • see bottom panel for lot number and expiration date

Inactive Ingredients

propylparaben, carboxymethylcellulose sodium, citric acid, corn syrup, FD and C red #40, flavors, glycerin, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, sucrose, xanthan gum

Package Label

Children's Non-Aspirin

Image Of Bottle Label (Childnonasp.carton)

Image Of Bottle Label (Childnonasp.carton)

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