Acetaminophen Pm Tablet, Film Coated
FDA Label NDC 73057-352

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Ulai Health Llc for the product Acetaminophen Pm (NDC 73057-352). 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 ingredients (in each caplet), purpose, uses, warnings, do not use, ask a doctor before use if you have, when using this product, ask a doctor or pharmacist before use if you are, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients (In Each Caplet)

Acetaminophen 500 mg

Diphenhydramine HCl 25 mg

Purpose

Pain reliever

Nighttime 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

    • 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.

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 a 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

Ask A Doctor Before Use If You Have

  • liver disease
  • a breathing problem such as emphysema or chronic bronchitis
  • trouble urinating due to an enlarged prostate gland
  • glaucoma

When Using This Product

  • drowsiness will occur
  • avoid alcoholic drinks
  • do not drive a motor vehicle or operating machinery

Ask A Doctor Or Pharmacist Before Use If You Are

  • taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers

Stop Use And Ask A Doctor If

  • sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness.
  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • new symptoms occur

    • These could be signs of a serious condition.

If Pregnant Or Breast-Feeding,

ask a health professional before use.

Keep Out Of Reach Of Children.

Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

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

Other Information

  • store at 20-250C (68-770F)

Inactive Ingredients

colloidal silicon dioxide, croscarmellose sodium, FD&C Blue #1, hypromellose, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized corn starch, purified water, stearic acid, titanium dioxide

Questions Or Comments?

(866) 562-2756 (Mon - Fri 8 AM to 4 PM EST)

Package Label.Principal Display Panel

PHARBEST

NDC 73057-352-03

Manufactured in the USA

Extra Strength

*COMPARE TO the active ingredients in TYLENOL® PM

ACETAMINOPHEN

PM

Pain Reliever

Nighttime Sleep Aid

Acetaminophen,

Diphenhydramine HCl

Non-habit forming

24 Caplets

* Please review the disclaimer below.