Acetaminophen Pm
FDA Label NDC 42912-0154

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Tds Pharm Co., Ltd. for the product Acetaminophen Pm (NDC 42912-0154). 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, liver warning:, do not use, ask a doctor before use if you have, 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 500mg

Diphenhydramine HCl 25mg

Purpose

Pain reliever

Sleep aid

Uses

temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessnes

Warnings

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Liver Warning:

This product contains acetaminophen.  Severe liver damage may occur if you take

  • more than 4,000ms 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 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

Ask A Doctor Before Use If 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 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 serious underlying medical illness
  • pain gets worse or lasts more than 10 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.

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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.  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 (see overdose warning)

    • adults and children under 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

  • do not use if safety seal under cap is broken or missing
  • store between 20-25°C (68-77°F)
  • see end panel for lot number and expiration date

Inactive Ingredients

corn starch, cydroxypropyl cellulose, hypromellose 2910, blue no.1, magnesium stearate, microcrystalline cellulose, polyethylene glycol 6000, sodium starch glycolate, titanium dioxide


Package Label.Principal Display Panel

non-aspirin PM

Image Of Carton Label (Nonaspirinpm.carton)

Image Of Carton Label (Nonaspirinpm.carton)

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