Zzzsleep
FDA Label NDC 76168-066

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 Zzzsleep (NDC 76168-066). 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)

Diphenhydramine HCl 25mg

Purpose

Sleep Aid

Uses

  • For the relief of occasional sleeplessness
  • Reduces time to fall asleep if have difficulty falling asleep

Warnings

Do not use

  • If children under 12 years of age
  • with any other product containing diphenhydramine, even one used on skin
  • with other drug that cause drowsiness such as antihistamines and nighttime cold/flu products
  • Do not use with generic NyQuil®

    • Ask a doctor before use if you have:

    • A breathing problem such as asthma, emphysema, or Chronic bronchitis
    • glaucoma
    • difficulty in urination due to enlargement of the prostate gland
    • heart disease
    • You are taking a diuretic

      Ask a doctor or pharmacist before use if you are taking sedative or tranquilizers or any other sleep-aid, when using this product :

    • Avoid alcoholic beverages and other drugs that cause drowsiness
    • Drowsiness will occur
    • Be careful when driving a motor vehicle or operating machinery

      Stop use and ask a doctor if sleeplessness persists continuously for more than two weeks.

      Insomnia 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.

Overdose Warning: Taking more than directed can cause serious health problems, In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

Take only one dose per day (24 hours)- see Overdose warning.

Adults and Children 12 years and over

  • One Dose = Two 25 mg LiquiCaps (50 mg) at bedtime if needed or as directed by a doctor

Other Information

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

Inactive Ingredients

FD&C Blue No. 1, FD&C Red No. 40, Gelatin, Glycerin, Polyethylene Glycol, Purified Water, Sorbitol, Titanium Dioxide

Questions?

Call 1-855-314-1850

TAMPER EVIDENT: This Package is safety sealed & child resistant. Use only if blisters are intact. If difficult to open, use scissors. 

Package Label.Principal Display Panel

3699cb9c-figure-01 (3699cb9c Figure 01)

3699cb9c-figure-01 (3699cb9c Figure 01)

NDC: 76168-066-02 –12 LIQUID GELS

Not for treating cold or flu – see warnings

* Please review the disclaimer below.