Acetaminophen Syrup
FDA Label NDC 63868-809

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 63868-809). 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.

Label Section Quick Index

Active Ingredient                         Purpose

(In each 15 mL)

in Acetaminophen 500 mg............. Pain reliever/fever reducer

Uses

  • temporarily relieves minor aches and pains due to:
    • the common cold
    • headache
    • backache
    • minor pain of arthritis
    • toothache
    • muscular aches
    • premenstrual and menstrual cramps
    • temporarily reduces fever

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:

  • more than 4,000 mg of acetaminophen in 24 hours
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product

    • Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

    • skin reddening
    • blisters
    • rash

      • if skin reaction occurs, stop use and seek medical help right away.

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 any of the inactive ingredients in this product.

Directions

  • do not take more than directed (see Overdose warning)
  • do not take more than 4 doses in any 24-hour period
  • measure only with dosing cup provided. Do not use any other dosing device.
  • mL=milliliter
  • keep dosing cup with product
  • adults and children 12 years and over
  • 30 mL every 6 hours while symptoms last
  • do not take more than 10 days unless directed by a doctor
  • children under 12 years: do not use

Other Information

  • each 15 mL contains: sodium 10 mg
  • store between 20-25°C (68-77°F). Do not refrigerate.
  • protect from light.

    • Questions or comments
    1-800-935-2362 (Mon-Fri 9am-5pm EST)

Inactive Ingredients

citric acid, D&C red #33, FD&C red #40, flavor, high fructose corn syrup, polyethylene glycol, propylene glycol, purified water, saccharin sodium,
sodium benzoate, sorbitol

Principal Display Panel

Containerlabel (Containerlabel)

Containerlabel (Containerlabel)

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