Excinol Night (acetaminophen)
FDA Label NDC 49638-105

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 Night (acetaminophen) (NDC 49638-105). 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 night (acetaminophen)500 mg, active ingredient, purpose, uses, warnings, do not use, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Excinol Night (Acetaminophen)500 Mg

Drug Facts

Active Ingredient

Acetaminophen 500 mg

Diphenhydramine HCl 25 mg

Purpose

Pain reliever

Night time sleep aid

Uses

  • temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness

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 nonprescription).
  • If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • with any other product containing diphenhydramine, even one used on skin
  • in children under 12 years of age
  • if you have ever had an allergic reaction to this product or any of its ingredients.

Directions

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

Adults and children 12 years and over:

  • take 2 caplets at bedtime
  • do not take more than 2 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)
  • do not use if neck wrap is broken or missing
  • see end panel for lot number and expiration date

Inactive Ingredients

Carnauba wax, FD&C blue# 1 al lake, FD&C blue# 2 al lake, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, stearic acid, titanium dioxide, triacetin.

Questions Or Comments?

call toll free 1-855-470-6722

* Please review the disclaimer below.