Acetaminophen Suspension
FDA Label NDC 63868-677

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Chain Drug Marketing Association Inc for the product Acetaminophen (NDC 63868-677). 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(in each 5 ml), uses temporarily:, warnings, do not use, otc - ask doctor, otc - ask doctor/pharmacist, stop use and ask a doctor if, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Active Ingredient                         Purpose(In Each 5 Ml)

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

  • 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.

      When using this product do not exceed recommended dose (see overdose warning)

Do Not Use

  • with any other drug containing acetaminophen (prescription 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

Otc - Ask Doctor

Ask a doctor before use if your child has liver disease

Otc - Ask Doctor/Pharmacist

Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin

Stop Use And Ask A Doctor If

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

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

Overdosage

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 right away 1-800-222-1222. Quick 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)
  • shake well before using
  • ml= milliliter
  • 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?
    1-800-935-2362 (Mon-Fri 9am-5pm EST)

Inactive Ingredients

acesulfame potassium, avicel, citric acid, FD&C blue no. 1, FD&C red no. 33, flavor, glycerine, high fructose corn syrup, polysorbate, propylene glycol, prosweet N & AK, purified water, sodium benzoate, sucralose, sorbitol, xanthan gum

Principal Display Panel

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