SPL v4
SPL
SPL Set ID 98437a72-1b98-4301-b92f-0c17b305cf59
Route
ORAL
Published
Effective Date 2021-04-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (50 mg)
Inactive Ingredients
Fd&c Blue No. 1 Gelatin Glycerin Polyethylene Glycol, Unspecified Sorbitol

Identifiers & Packaging

Pill Appearance
Imprint: A99 Shape: oval Color: blue Size: 13 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-04-15
Description

(in each softgel ) Diphenhydramine HCI 50 mg

Purpose

Nighttime sleep-aid

Medication Information

Purpose

Nighttime sleep-aid

Description

(in each softgel ) Diphenhydramine HCI 50 mg

Use
  • for relief of occasional sleeplessness
Directions
  • adults and children 12 years of age and over: 1 softgel (50 mg) at bedtime if needed, or as directed by a doctor
Do Not Use
  • for children under 12 years of age

  • with any other product containing diphenhydramine, even one used on skin
Active Ingredient

(in each softgel )

Diphenhydramine HCI 50 mg

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

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.

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

Structured Label Content

Use
  • for relief of occasional sleeplessness
Purpose

Nighttime sleep-aid

Directions
  • adults and children 12 years of age and over: 1 softgel (50 mg) at bedtime if needed, or as directed by a doctor
Do Not Use (Do not use)
  • for children under 12 years of age

  • with any other product containing diphenhydramine, even one used on skin
Active Ingredient (Active ingredient)

(in each softgel )

Diphenhydramine HCI 50 mg

Inactive Ingredients (Inactive ingredients)

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

Principal Display Panel (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

When Using This Product (When using this product)

avoid alcoholic drinks

Stop Use and Ask A Doctor If (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, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of Reach of Children. (Keep out of reach of children.)

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

Ask A Doctor Before Use If You Have (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 (Ask a doctor or pharmacist before use if you are)

taking sedatives or tranquilizers

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:54.462657 · Updated: 2026-03-14T23:06:03.178139