Excinol Extra (acetaminophen)
FDA Label NDC 49638-111

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by America Medic & Science, Llc for the product Excinol Extra (acetaminophen) (NDC 49638-111). 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 excinol extra 1000 mg, active ingredient, purpose, uses, warnings, do not use, overdose warning, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Excinol Extra 1000 Mg

Drug Facts

Active Ingredient

Acetaminophen 1000 mg

Purpose

Pain reliever/fever reducer

Uses

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

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.

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 you have ever had an allergic reaction to acetaminophen or any of the inactive ingredients in this product.

Overdose Warning

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

do not take more than directed (see overdose warning).

Adults and children 12 years and over:

  • take 1 caplet every 6 to 8 hours
  • Do not take more than 4 caplets of this product in 24 hours.

    • Children under 12 years:

    • do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage.

Other Information

  • store between 20-25°C (68-77°F)
  • see end panel for lot number and expiration date

Inactive Ingredients

  • Carnauba wax, hypromellose, polyethylene glycol, propylene glycol, povidone, pregelatinized starch, stearic acid, titanium dioxide

Questions Or Comments?

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