Acetaminophen Pm Tablet
FDA Label NDC 17714-133

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Advance Pharmaceutical Inc. for the product Acetaminophen Pm (NDC 17714-133). 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 caplet)

Acetaminophen 500 mg

Diphenhydramine HCl 25 mg

Purpose

Pain Reliever / Night time 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 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.
    • with any other drug containing diphenhydramine, even one used on skin
    • in children under 12 years of age

      • Ask a doctor before use if the you have

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

        • Ask a doctor or pharmacist before use if you are

        • taking the blood thinning drug warfarin
        • taking sedative 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 serious underlying medical illness.
            • Any new symptoms appear
            • redness or swelling is present
            • pain gets worse or lasts more than 10 days
            • fever gets worse or lasts more than 3 days

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

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 if needed or as directed by a doctor
  • 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 15-30 °C (59-86 °F)

Inactive Ingredients

crosscarmellose sodium, FD&C blue # 1, hypromellose, microcrystalline cellulose, polyethylene glycol 400, povidone, silicon dioxide, starch, stearic acid, titanium dioxide

Questions Or Comments

Call 631-981-4600 8.30 am- 4.30 pm ET, Monday-Friday

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Manufactured by: Advance Pharmaceutical, Inc. Holtsville, NY 11742

Package Label.Principal Display Panel

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NDC: 17714-133-50 – 50 COUNT CAPLETS

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