Rite Aid Nighttime Sleep Aid Liquid
FDA Label NDC 11822-7530

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Rite Aid Corporation for the product Rite Aid Nighttime Sleep Aid (NDC 11822-7530). 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 30 ml dose cup), purpose, uses, do not use, ask a doctor before use if you have, otc - ask doctor/pharmacist, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222.

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

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

Otc - Ask Doctor/Pharmacist

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

When Using This Product

  • ▪avoid alcoholic beverages

Otc - Stop Use

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.

Otc - Pregnancy Or Breast Feeding

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

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

Directions

  • ▪take only one dose per day (24 hours)
  • ▪measure with dosing cup provided
    • 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 contains: sodium 10 mg
  • ▪store at room temperature

Inactive Ingredients

anhydrous citric acid, flavor, glycerin, potassium citrate, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum.

Questions Or Comments?

1-866-467-2748

Principal Display Panel

Compare to the active ingredient in ZzzQuil™ Nighttime Sleep-Aid*

NDC# 11822-7530-1

Nighttime

Sleep-aid

Diphenhydramine HCl

Non-Habit Forming

Makes you fall asleep fast

Sugar-Free,

  • Dye-Free,
  •  Aspartame-Free

    • Berry Flavor

    Naturally and Artificially Flavored

    No added alcohol

    Not for Pain. Not for Colds. Just for Sleep

    12 FL. OZ. (354 mL)

    *This product is not manufactured or distributed by Procter & Gamble, the distributor of ZzzQuil™Nighttime Sleep-Aid.

    Distributed by

    Riteaid Nighttime Sleep Aid Diphenhydramine HCl (Image 01)

    Riteaid Nighttime Sleep Aid Diphenhydramine HCl (Image 01)

* Please review the disclaimer below.