Childrens Acetaminophen Suspension
FDA Label NDC 82568-0010

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Aarna Usa Inc. for the product Childrens Acetaminophen (NDC 82568-0010). 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, uses, warnings, ask a doctor or pharmacist before use if the child has, ask  doctor or pharmacist before use if your child is, stop use and ask a doctor if, overdose warning:, keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Active Ingredient

Active ingredient(in each 5mL)                                             Purpose
Acetaminophen 160 mg ………………………….........Pain reliever/fever reducer

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 then 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, persist or 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 anyof the inactive ingredients in this product.

Ask A Doctor Or Pharmacist Before Use If The Child Has

liver disease.

Ask  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

  • pain gets worse or lasts for more then 5 days
  • fever gets worse or last for more then 3 days
  • new symptoms occur redness or swelling is present. These could be signs of a serious condition. 

Overdose Warning:

In case of overdose, get medical help to contact Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical even if you do not notice any signs or symptoms.

Keep Out Of Reach Of Children

Other Information

  • Store at room temperature 20°-25°C (68°-77°F). Protect from freezing. Protect from light.

Inactive Ingredients

Anhydrous Citric Acid, D&C Red #33, FD&C Blue #1, Grape Flavor, Glycerin, Microcrystalline cellulose and Sodium Methyl Cellulose, Potassium Sorbate, Purified Water, Sorbitol, Sucralose, Sucrose, Xanthan gum.

Questions Or Comments?

Call toll-free 1-877-225-6999

Manufactured for:

AARNA USA INC.

Leland, NC-28451

Package Label.Principal Display Panel

1 (4oz 1)

1 (4oz 1)

2 (4oz 2)

2 (4oz 2)

3 (8oz 1)

3 (8oz 1)

4 (8oz 2)

4 (8oz 2)

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