Acetaminophen Suspension
FDA Label NDC 69729-028

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Opmx Llc for the product Acetaminophen (NDC 69729-028). 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                         purpose, uses, warnings, do not use, directions, other information, inactive ingredients, principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Active Ingredient                         Purpose

Acetaminophen 160 mg............. Pain reliever/fever reducer

Uses

temporarily:

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

Warnings

Liver warning: This product contains acetaminophen.
Severe liver damage may occur if your child takes 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
    • blister
    • 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 (prescnption or non-prescription). 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.

Directions

  • this product does not contain directions or complete warnings for adult use
  • do not give more than directed (see overdose warning)
  • shake well before using
  • mL= millilitar
  • find right dose on chart below, if possible, use weight to dose; otherwise, use age
  • only use enclosed measuring syringe
  • repeat dose every 4 hours while symptoms last
  • do not give more than 5 times in 24 hours
  • Weight (Ib)

    Age (yr)

    Dose (mL)

    or as directed by doctor

    under 24

    under 2 years

    ask a doctor

    24-35

    2-3 years

    5 mL

Other Information

  • store between 20°-25°C (68°-77°F)
  • protect from freezing
  • protect from light
  • Questions or comments?
    Call toll free 619-600-5632
    Monday through Fnday 9AM - 5PM EST

Inactive Ingredients

acesulfame potassium, avicel, citric acid, FD&C red no. 40, flavor, glycerine, high fructose corn syrup, polysorbate, propylene glycol, prosweet N&AK, purified water, sodium benzoate, sucralose, sorbitol, xanthan gum.

Principal Display Panel

Containerlabel-028 (Containerlabel 028)

Containerlabel-028 (Containerlabel 028)

Containerlabel-047 (Containerlabel 047)

Containerlabel-047 (Containerlabel 047)

Containerlabel-068 (Containerlabel 068)

Containerlabel-068 (Containerlabel 068)

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