Nighttime Sleep-aid Liquid
FDA Label NDC 83324-015

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Chain Drug Marketing Association Inc. for the product Nighttime Sleep-aid (NDC 83324-015). 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 30ml), purpose, use(s), warnings, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use 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 30Ml)

Diphenhydramine HCl 50 mg

Purpose

Nighttime sleep-aid

Use(S)

  • for relief of occasional sleeplessness
  • helps you to fall asleep if you have difficulty falling asleep

Warnings

.

Do Not Use

  • for children under 12 years of age
  • with any other product containing diphenhydramine, even one used on skin
  • with other drugs that cause drowsiness such as antihistamines and nighttime cold/flu products

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 the prostate gland
  • heart disease

Ask A Doctor Or Pharmacist Before Use If You Are

taking sedatives 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 Doctor If

sleepleness 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
  • only use dosage cup that is included with this product for accurate dosing
  • mL = millilitere; Tbsp = teblespoons


    •   Age 
     Dose 
     adults & chlidren 12 year & over one = 30 mL (2Tbsp) at bedtime if needed or as directed by a doctor
     childrens under 12 years do not use

Other Information

  • each 30 mL (2 Tbsp) contain: sodium 30 mg
  • store at room temperature
  • protect from light

Inactive Ingredients

citric acid, FD&C Blue # 1, FD&C Red # 40, flavors, high fructose corn syrup, polyoxyl 40 stearate, purified water, saccharine sodium, sodium benzoate, sodium citrate.

Principal Display Panel

NDC 83324-015-06

QC® QUALITY CHOICE

*Compare to the Active ingredient in ZzzQUIL® Nighttime Sleep Aid

Ezz Nite Sleep Aid

Nighttime Sleep-Aid

Diphenhydramine HCl

50 mg Per 30 mL


Relieves:

Occasional Sleeplessness


Warming Berry Flavor

6 FL OZ (177 ML)

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Qch-633.jpg (Qch 633)

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