Dormmy-lon Tablet
FDA Label NDC 83164-000

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Haendel Farma, S.a. De C.v. for the product Dormmy-lon (NDC 83164-000). 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 (in each pill), purpose, uses:, warnings, ask a doctor before use if you have:, do not use, ask a doctor or pharmacist before use it 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 Ingredient (In Each Pill)

Diphenhydramine hydrochloride 25 mg

Purpose

Nighttime sleep-aid

Uses:

  • Helps to reduce difficulty in falling sleep
  • For the relief of occasional sleeplessness

Warnings

Ask A Doctor Before Use If You Have:

  • A breathing problem such as emphysema or chronic bronchitis
  • Glaucoma
  • Difficulty in urination due to an enlarged prostate gland

Do Not Use

  • For children under 12 years of age
  • With any other product containing diphehydramine

Ask A Doctor Or Pharmacist Before Use It If You Are

taking sedatives, tranquilizers or any other drugs

When Using This Product

  • Avoid alcoholic beverages

Stop Use And Ask A Doctor If

sleeplessness persists continuosly for more than 2 weeks, In sommia may be a symptom of serious underlying medical illness.

If Pregnant Or Breast-Feeding,

ask a health professional before use.

Keep Out Of Reach Of Children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

  • Take only one dose per day (24 hours)
    •  Adults and children 12 years & over 2 pills or as directed by a doctor
     children under 12 years Do not use 

Inactive Ingredients

Lactose, P.V.P., Starch, Blue Color FD&C # 1, Microcrystalline Cellulose, Croscarmellose, Sodium, Magnesium Stearate

Other Information

  • Store at 68° - 77 °F (20-25 °C)
  • Protect from light.
  • See printed for lot number and exp. date.

* Please review the disclaimer below.