Pain Relief Pm
FDA Label NDC 63548-0065

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Avema Pharma Solutions for the product Pain Relief Pm (NDC 63548-0065). 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, ask a doctor or pharmacist before use if you are, when using this product, 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, minor aches, and pains accompanying sleeplessness.

Warnings

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

  • more than 2 caplets in 24 hours, which is the maximum daily amount
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product


Do Not Use

  • with other products containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • 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
  • asthma
  • breathing problems such as emphysema or chronic bronchitis
  • glaucoma
  • difficulty in urinating due to an enlargement of the prostate gland

Ask A Doctor Or Pharmacist Before Use If You Are

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

When Using This Product

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

Stop Use And Ask A Doctor If

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

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health care professional before use.

Otc - Keep Out Of Reach Of Children

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
  • 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 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 at room temperature 15°-30°C (59°-86°F), avoid high humidity and excessive heat
  • do not use if imprinted safety seal under cap is broken or missing
  • **This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered
    trademark Tylenol® PM

Inactive Ingredients

Colloidal silicon dioxide*, croscarmellose sodium*, Dand C Yellow No. 10 Aluminum Lake*, FDandC Blue No.1 Aluminum Lake, FDandC Blue No. 2 Aluminum Lake, hypromellose, magnesium silicate*, magnesium stearate*, microcrystalline cellulose, mineral oil*, polyethylene glycol,polyvinyl alcohol*, povidone, pregelatinized starch, silica*, sodium starch glycolate*, stearic acid, talc*, titanium dioxide, triacetin*, and yellow iron oxide**contains one or more of these ingredients

Product Labeling

**Compare to the active
ingredients in Tylenol® PM®


EXTRA STRENGTH

Pain Relief PM

Acetaminophen 500 mg, Diphenhydramine HCl 25 mg

Pain reliever /
Nighttime Sleep-Aid

24 CAPLETS


Do not use if imprinted safety seal under cap is broken or missing


Pain Relief Pm (Avema Painreliefpm)

Pain Relief Pm (Avema Painreliefpm)

Pain Relief Pm (Avema Painreliefpm0)

Pain Relief Pm (Avema Painreliefpm0)

* Please review the disclaimer below.