Kroger Nighttime Sleep-aid Capsule, Liquid Filled
FDA Label NDC 30142-558

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by The Kroger Co for the product Kroger Nighttime Sleep-aid (NDC 30142-558). 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, use, 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 softgel)

Diphenhydramine HCI 50 mg

Purpose

Nighttime sleep-aid

Use

  • for relief of occasional sleeplessness

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
  • trouble urinating due to an enlarged prostate gland

Ask A Doctor Or Pharmacist Before Use If You Are

taking sedatives or tranquilizers

When Using This Product

avoid alcoholic drinks

Stop Use And Ask A Doctor If

sleeplessness persist 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.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

  • adults and children 12 years of age and over: 1 softgel (50 mg) at bedtime if needed, or as directed by a doctor

Inactive Ingredients

FD&C Blue No. 1, Gelatin, Glycerine, Polyethylene Glycol, Sorbitol.

Principal Display Panel

DISTRIBUTED BY THE KROGER CO.

CINCINNATI, OHIO 45202

MADE IN CANADA

FOR MORE PRODUCT INFORMATION,

SCAN UPC USING YOUR KROGER APP

OR CALL 800-632-6900

Questions or Comments 1-800-632-6900

UNISKRO REV 3/21

Nighttime Sleep-aid (Carton)

Nighttime Sleep-aid (Carton)

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