Ez Nite Sleep
FDA Label NDC 30142-229

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by The Kroger Co. for the product Ez Nite Sleep (NDC 30142-229). 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 other, active ingredient (in each softgel), purpose, uses, warnings, do not use, ask a doctor before use if you have, otc - ask doctor/pharmacist, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Drug Facts (continued)

Drug Facts (continued)

Active Ingredient (In Each Softgel)

Diphenhydramine HCl 25mg

Purpose

Nighttime sleep-aid

Uses

  • for the relief of occasional sleeplessness
  • reduces time to fall asleep if you have difficulty falling asleep

Warnings

Warnings

Do Not Use

  • for children under 12 years of age
  • with any other product containing diphenhydramine, even one used on skin.

Ask A Doctor Before Use If You Have

  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • difficulty in urination due to enlargement of prostate gland

Otc - Ask Doctor/Pharmacist

Ask a doctor or pharmacist before use if you are  taking sedatives or tranquilizers 

Otc - When Using

When using this product 

  • avoid alcoholic beverages

Otc - Stop Use

Stop use and ask a doctor if sleeplessness persists continously for more than 2 weeks. Insomnia may be a symptom be a symptom of serious underlying medical illness.

Otc - Pregnancy Or Breast Feeding

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

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. In care of overdose, get medical help or contact a Poison Control Center right away.

Directions

  • take only one dose per day (24 hours)
    •  adults & children 12 years & over    One dose= TWO 25 mg softgels (50 mg) at bed time if needed or as directed by a doctor
     children under 12 years    Do not use

Other Information

  • Store at 20-25° C (68-77° F)
  • avoid excessive heat above 40° C (104° F)
  • Protect from light

Inactive Ingredients

FD&C Blue#1, FD&C Red#40, gelatin, glycerin, polyethylene glycol, propylene glycol, purified water, sorbitol sorbitan solution, titanium dioxide

Otc - Questions

Questions or comments? 1-800-632-6900

Principal Display Panel

COMPARE TO the active ingredient of ZZZQUIL® *see side panel

NDC 30142-224-24

Kroger®

Nighttime Sleep-Aid

EZ Nite Sleep

Diphenhydramine HCL 25 mg

Helps Reduce Difficulty Faling Asleep

actual size

Non-Habit Forming

Not fro Treating Cold or Flu- See Warnings

24 SOFTGELS

*Zzzquil® is a registered trademark of The Procter & Gamble Company, Cincinnati, OH 45202. The Procter & Gamble Comopany is not affiliated with The Kroger Co. ir this product.

* Please review the disclaimer below.