Kroger Nighttime Sleep-aid Liquid
FDA Label NDC 41226-730

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Kroger Company for the product Kroger Nighttime Sleep-aid (NDC 41226-730). 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

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 asthma, 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 aretaking sedatives or tranquilizers.

When Using This Product

  • avoid alcoholic beverages

Otc - Stop Use

Stop use and ask a doctor ifsleeplessness 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.

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)
  • Only use dose cup provided

    • adults & children 12 yrs & over

    30 mL at bed time if needed or as directed by a doctor

    Children under 12 yrs

    Do not use

Other Information

  • each 30 mL dose cup contains: potassium 5 mg; sodium 10 mg
  • store at room temperature

Inactive Ingredients

anhydrous citric acid, FD&C blue 1, FD&C red 40, 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 41226-730-12

Nighttime

Sleep-Aid

Diphenhydramine HCl

  • Non-habit forming
  • Makes you fall asleep fast

    • Berry Flavor

    Naturally & artificially flavored

    No added alcohol

    Not for pain. Not for Colds.

    Just for Sleep

    12 FL. OZ. (354 mL)

    TAMPER EVIDENT:Do not use if printed shrink band is missing or broken

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

    Distributed by:

    Kroger Nighttime Sleep Aid Berry Flavor 12 Fl Oz (Image 01)

    Kroger Nighttime Sleep Aid Berry Flavor 12 Fl Oz (Image 01)

* Please review the disclaimer below.