Pain Relief Pm Tablet
FDA Label NDC 76168-119

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Velocity Pharma for the product Pain Relief Pm (NDC 76168-119). 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, keep out of reach of children., directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

(in each tablet)

Acetaminophen 500mg

Diphenhydramine HCl 25mg

Purpose

pain reliever/fever reducer

Nighttime sleep aid

Uses

  • temporarily 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 4000 mg of acetaminophen in 24 hours
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks everyday while using this product

    • Overdose warning: Taking more than recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

      • do not use

      • with any other drug containing acetaminophen (prescription or not prescription). 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
      • With other products containing diphenhydramine, even one used on skin.

        • ask a doctor before use if you have

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

          • ask your doctor or pharmacist before use if you are

          • taking the blood thinning drug warfarin
          • taking sedative or tranquilizers.

            • When using this product

            • avoid alcoholic drinks
            • do not drive a motor vehicle or operate machinery, this product will cause drowsiness

              • 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.

Keep Out Of Reach Of Children.

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

Directions

  • do not exceed recommended dose
  • 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 at 25 °C (77°F) excursions permitted between 15-30°C(59-86°F)
  • 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, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, hypromellose, microcrystalline cellulose, polyethylene glycol, povidone,  pregelatinized starch, purified water, Sodium metabisulfite, Sodium starch glycolate, stearic acid, Titanium Dioxide, Talc

Questions Or Comments

Call toll free 1-855-314-1850

Package Label.Principal Display Panel

NDC: 76168-119-25   50 COUNT

* Please review the disclaimer below.