Night Time Sleep Aid Solution
FDA Label NDC 42507-959

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Hyvee Inc for the product Night Time Sleep Aid (NDC 42507-959). 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 30 ml dose cup), purpose, uses, 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, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient (In Each 30 Ml Dose Cup)

Diphenhydramine HCl 50 mg

Purpose

Nighttime sleep-aid

Uses

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

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
  • with other Nighttime products

Ask A Doctor Before Use If You Have

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

Ask A Doctor Or Pharmacist Before Use If You Are

taking sedatives or tranquilizers

When Using This Product

  • avoid alcoholic beverages
  • drowsiness will occur
  • 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.

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. (1-800-222-1222)

Directions

  • take only one dose per day (24 hours) – see Overdose warning
  • use dose cup
    • adults & children 12 yrs & over30 mL at bed time if needed or as directed by a doctorchildren under 12 yrsdo not use
     
     
     
     

Other Information

  • each 30 mL dose cup contains: sodium 20 mg
  • store at 20-25˚C (68-77˚F)
  • protect from light. Does not meet USP <671>.

Inactive Ingredients

alcohol, anhydrous citric acid, FD&C blue #1, FD&C red #40, flavor, high fructose corn syrup, poloxamer 407, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium citrate

Questions Or Comments?

1-800-719-9260

Package/Label Principal Display Panel

COMPARE TO the Active Ingredient of Vicks® ZzzQuil®

Nighttime Sleep Aid

Diphenhydramine HCl 50 mg per 30 mL

Relieves Occasional Sleeplessness

#1 Doctor Recommended Active Ingredient

Not for Treating Cold or Flu

See Warnings

Non-Habit Forming

10% ALCOHOL

Berry Flavor

6 FL OZ (117 mL)

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