Diphenhydramine Hcl 50mg, Kroger, Made In India

SPL v3

SPL

SPL Set ID 0f2c1c6a-29bc-e4a8-e063-6394a90a28cb

Route

ORAL

Published

Effective Date 2025-12-01

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Diphenhydramine (50 mg)

Inactive Ingredients

Polyethylene Glycol 600 Sorbitan Fd&c Blue No. 1 Gelatin Polyethylene Glycol 400 Water Glycerin Propylene Glycol Sorbitol

Identifiers & Packaging

Pill Appearance

Imprint: B50 Shape: oval Color: blue Size: 13 mm Score: 1

Marketing Status

OTC MONOGRAPH DRUG Active Since 2024-03-20

Description

Diphenhydramine HCl 50 mg

Purpose

Nighttime sleep-aid

Medication Information

Purpose

Nighttime sleep-aid

Description

Diphenhydramine HCl 50 mg

Uses

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

Section 42229-5

DO NOT USE IF TAMPER-EVIDENT SEAL UNDER BOTTLE CAP IMPRINTED WITH “SEALED for YOUR PROTECTION” IS BROKEN OR MISSING.

READ AND KEEP CARTON FOR COMPLETE WARNINGS AND INFORMATION

Unisom® and SleepGels® are registered

trademarks of Chattem, Inc. Chattem, Inc. is not

affiliated with The Kroger Co. or this product.

‡OUR PHARMACIST RECOMMENDED

DISTRIBUTED BY THE KROGER CO.

CINCINNATI, OHIO 45202

MADE IN INDIA

For More Product Information,

Scan UPC Using Your Kroger App or

Call 800-632-6900

Our Brands. Our Guarantee.

Love It or Your Money Back.

www.kroger.com

R0724

L0000883

Lot No.:

Exp. Date:

Mfg. Lic. No.: TN00002123

Warnings

Do not use

■ for children under 12 years of age ■ with any other product containing diphenhydramine, even one used on skin.

64's Count

NDC 30142-681-18

Kroger

health

COMPARE TO THE ACTIVE

INGREDIENT IN UNISOM ^®SLEEPGELS ^®

MAXIMUM STRENGTH

ONE SOFTGEL PER DOSE

NightTime Sleep-Aid

Diphenhydramine HCl Capsules, USP 50 mg

FALL ASLEEP FAST

SLEEP SOUNDLY

SAFE,

NON-HABIT

FORMING

64 SOFTGELS*

(*LIQUID-FILLED CAPSULES)

Directions

■ Adults and children 12 years of age and over:One softgel (50 mg) at bedtime if needed, or as directed by a doctor.

■ swallow whole; do not crush, chew, or dissolve

Other Information

■ store at 20°C to 25°C (68°F to 77°F) ■ avoid high humidity and excessive heat above 40°C (104°F).

■ protect from light

Inactive Ingredients

FD&C blue #1, gelatin, glycerin, polyethylene glycol 400, polyethylene glycol 600, propylene glycol, purified water, sorbitol sorbitan solution

Questions Or Comments?

call toll-free 1-888-235-2466 (Mon-Fri 9AM-5PM EST)

When Using This Product

■ avoid alcoholic beverages ■ be careful when driving a motor vehicle or operating machinery

Stop Use and Ask A Doctor If

sleeplessness persists continuosly for more than 2 weeks, consult your doctor. Insomnia may be a symptom of serious underlying medical illness.

Keep Out of Reach of Children.

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

If Pregnant Or Breast Feeding,

ask a health professional before use.

Active Ingredient (in Each Capsule)

Diphenhydramine HCl 50 mg

Ask A Doctor Before Use If You Have

■ glaucoma

■ a breathing problem such as emphysema or chronic bronchitis

■ difficulty in urination due to enlargement of the prostate gland

Ask A Doctor Or Pharmacist Before Use

if you are taking sedatives or tranquilizers.

Structured Label Content

Uses

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

Section 42229-5 (42229-5)

DO NOT USE IF TAMPER-EVIDENT SEAL UNDER BOTTLE CAP IMPRINTED WITH “SEALED for YOUR PROTECTION” IS BROKEN OR MISSING.

READ AND KEEP CARTON FOR COMPLETE WARNINGS AND INFORMATION

Unisom® and SleepGels® are registered

trademarks of Chattem, Inc. Chattem, Inc. is not

affiliated with The Kroger Co. or this product.

‡OUR PHARMACIST RECOMMENDED

DISTRIBUTED BY THE KROGER CO.

CINCINNATI, OHIO 45202

MADE IN INDIA

For More Product Information,

Scan UPC Using Your Kroger App or

Call 800-632-6900

Our Brands. Our Guarantee.

Love It or Your Money Back.

www.kroger.com

R0724

L0000883

Lot No.:

Exp. Date:

Mfg. Lic. No.: TN00002123

Purpose

Nighttime sleep-aid

Warnings

Do not use

■ for children under 12 years of age ■ with any other product containing diphenhydramine, even one used on skin.

64's Count (64's count)

NDC 30142-681-18

Kroger

health

COMPARE TO THE ACTIVE

INGREDIENT IN UNISOM ^®SLEEPGELS ^®

MAXIMUM STRENGTH

ONE SOFTGEL PER DOSE

NightTime Sleep-Aid

Diphenhydramine HCl Capsules, USP 50 mg

FALL ASLEEP FAST

SLEEP SOUNDLY

SAFE,

NON-HABIT

FORMING

64 SOFTGELS*

(*LIQUID-FILLED CAPSULES)

Directions

■ Adults and children 12 years of age and over:One softgel (50 mg) at bedtime if needed, or as directed by a doctor.

■ swallow whole; do not crush, chew, or dissolve

Other Information (Other information)

■ store at 20°C to 25°C (68°F to 77°F) ■ avoid high humidity and excessive heat above 40°C (104°F).

■ protect from light

Inactive Ingredients (Inactive ingredients)

FD&C blue #1, gelatin, glycerin, polyethylene glycol 400, polyethylene glycol 600, propylene glycol, purified water, sorbitol sorbitan solution

Questions Or Comments? (Questions or comments?)

call toll-free 1-888-235-2466 (Mon-Fri 9AM-5PM EST)

When Using This Product (When using this product)

■ avoid alcoholic beverages ■ be careful when driving a motor vehicle or operating machinery

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

sleeplessness persists continuosly for more than 2 weeks, consult your doctor. Insomnia may be a symptom of serious underlying medical illness.

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 (1-800-222-1222) right away.

If Pregnant Or Breast Feeding, (If pregnant or breast- feeding,)

ask a health professional before use.

Active Ingredient (in Each Capsule) (Active ingredient (in each capsule))

Diphenhydramine HCl 50 mg

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

■ glaucoma

■ a breathing problem such as emphysema or chronic bronchitis

■ difficulty in urination due to enlargement of the prostate gland

Ask A Doctor Or Pharmacist Before Use (Ask a doctor or pharmacist before use)

if you are taking sedatives or tranquilizers.

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"Uses": "■ for relief of occasional sleeplessness ■ reduces time to fall asleep if you have difficulty falling asleep", "42229-5": "DO NOT USE IF TAMPER-EVIDENT SEAL UNDER BOTTLE CAP IMPRINTED WITH “SEALED for YOUR PROTECTION” IS BROKEN OR MISSING. READ AND KEEP CARTON FOR COMPLETE WARNINGS AND INFORMATION Unisom® and SleepGels® are registered trademarks of Chattem, Inc. Chattem, Inc. is not affiliated with The Kroger Co. or this product. ‡OUR PHARMACIST RECOMMENDED DISTRIBUTED BY THE KROGER CO. CINCINNATI, OHIO 45202 MADE IN INDIA For More Product Information, Scan UPC Using Your Kroger App or Call 800-632-6900 Our Brands. Our Guarantee. Love It or Your Money Back. www.kroger.com R0724 L0000883 Lot No.: Exp. Date: Mfg. Lic. No.: TN00002123", "Purpose": "Nighttime sleep-aid", "Warnings": "Do not use ■ for children under 12 years of age ■ with any other product containing diphenhydramine, even one used on skin.", "64's count": "NDC 30142-681-18 Kroger health COMPARE TO THE ACTIVE INGREDIENT IN UNISOM ® SLEEPGELS ® MAXIMUM STRENGTH ONE SOFTGEL PER DOSE NightTime Sleep-Aid Diphenhydramine HCl Capsules, USP 50 mg FALL ASLEEP FAST SLEEP SOUNDLY SAFE, NON-HABIT FORMING 64 SOFTGELS* (*LIQUID-FILLED CAPSULES)", "Directions": "■ Adults and children 12 years of age and over: One softgel (50 mg) at bedtime if needed, or as directed by a doctor. ■ swallow whole; do not crush, chew, or dissolve", "Other information": "■ store at 20°C to 25°C (68°F to 77°F) ■ avoid high humidity and excessive heat above 40°C (104°F). ■ protect from light", "Inactive ingredients": "FD&C blue #1, gelatin, glycerin, polyethylene glycol 400, polyethylene glycol 600, propylene glycol, purified water, sorbitol sorbitan solution", "Questions or comments?": "call toll-free 1-888-235-2466 (Mon-Fri 9AM-5PM EST)", "When using this product": "■ avoid alcoholic beverages ■ be careful when driving a motor vehicle or operating machinery", "Stop use and ask a doctor if": "sleeplessness persists continuosly for more than 2 weeks, consult your doctor. Insomnia may be a symptom of serious underlying medical illness.", "Keep out of reach of children.": "In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.", "If pregnant or breast- feeding,": "ask a health professional before use.", "Active ingredient (in each capsule)": "Diphenhydramine HCl 50 mg", "Ask a doctor before use if you have": "■ glaucoma ■ a breathing problem such as emphysema or chronic bronchitis ■ difficulty in urination due to enlargement of the prostate gland", "Ask a doctor or pharmacist before use": "if you are taking sedatives or tranquilizers."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:23.059515 · Updated: 2026-03-14T23:10:46.361818