Children Acetaminophen Oral Solution Liquid
FDA Label NDC 83939-0010

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Verityrx. Llc for the product Children Acetaminophen Oral Solution (NDC 83939-0010). 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 otc - active ingredient, otc - purpose, warnings, indications & usage, otc - pregnancy or breast feeding, otc - keep out of reach of children, dosage & administration, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active ingredient (per 5 mL teaspoonful)

Acetaminophen 160 mg

Otc - Purpose

Purpose

Pain Reliever/Fever Reducer

Warnings

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 thoat 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 acetaminophe or any of the inactive indreadients in this product.

        • Ask a doctor before use if your child hasliver disease.

        Ask a doctor before use if your child istaking the blood thinning drug warfarin.

        When using this product: Do not exceed recommended dose.

        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.

Indications & Usage

Uses

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

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. In case of overdose, get medical help or contact a Paoison Control Center right away. Quick medical attention is critical for adults/children even if you do not notice any signs or symptoms.

Dosage & Administration

Directions

  • do not take more than directed
  • find dose in chart below
  • if possible, use weight to dose, otherwise use age
  • dosage may be repeasted every 4 hours, or as directed by a doctor
  • do not give more than 5 doses in 24 hours
    • Weight (lbs)under 2424-3536-4748-5960-7172-95
    Age (years)under 22 to 34 to 56 to 89 to 1011
    Dosage Teaspoonful (tsp)consult Physician1 tsp (5 mL)1 1/2 tsp (7.5 mL)2 tsp (10 mL)2 1/2 tsp (12.5 mL)3 tsp (15 mL)

Inactive Ingredient

Inactive ingredients: artificial and natural cherry flavor, citric acid, FD&C Red #40, methylparaben, polyethylene glycol, propylene glycol, propylparaben, purified water, sodium citrate, sucralose

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