Whole Foods-diphenhydramine Hcl Capsules, 50 Mg Dye Free

Whole Foods-diphenhydramine Hcl Capsules, 50 Mg Dye Free
SPL v3
SPL
SPL Set ID 35acf7d9-e567-996d-e063-6394a90a1cf6
Route
ORAL
Published
Effective Date 2025-05-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (50 mg)
Inactive Ingredients
Polyethylene Glycol 600 Sorbitan Gelatin Polyethylene Glycol 400 Water Glycerin Propylene Glycol Sorbitol

Identifiers & Packaging

Pill Appearance
Imprint: DF50 Shape: oval Color: white Size: 13 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-05-21

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 IS BROKEN OR MISSING.

READ AND KEEP CARTON FOR COMPLETE WARNINGS AND INFORMATION

DISTRIBUTED BY: WHOLE FOODS MARKET I 550 BOWIE STREET, AUSTIN, TX 78703

©2020 WHOLE FOODS MARKET IP, INC. I www.wholefoodsmarket.com

PRODUCT OF INDIAI**THIS PRODUCT IS NOT MANUFACTURED OR DISIRIBUTED BY THE OWNERS OF UNISOM® SLEEPGELS®

L0000950 R0125

Mfg. Lic. No.: TN00002123

Lot No.:

Exp. Date:

Warnings

Do not use

■ for children under 12 years of age

■ with any other product containing diphenhydramine, even one used on skin.

32s Count

NDC 42681-0051-1

365

WHOLE FOODS

MARKET

Nighttime

Sleep-Aid

Diphenhydramine HCl

Capsules USP, 50 mg

Maximum Strength

Fall asleep fast & Sleep Soundly

safe, non habit-forming

**Compare to the A ctive Ingredient in Unisom® SleepGels®

One softgel per dose

32

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

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 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 IS BROKEN OR MISSING.

READ AND KEEP CARTON FOR COMPLETE WARNINGS AND INFORMATION

DISTRIBUTED BY: WHOLE FOODS MARKET I 550 BOWIE STREET, AUSTIN, TX 78703

©2020 WHOLE FOODS MARKET IP, INC. I www.wholefoodsmarket.com

PRODUCT OF INDIAI**THIS PRODUCT IS NOT MANUFACTURED OR DISIRIBUTED BY THE OWNERS OF UNISOM® SLEEPGELS®

L0000950 R0125

Mfg. Lic. No.: TN00002123

Lot No.:

Exp. Date:

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.

32s Count (32s count)

NDC 42681-0051-1

365

WHOLE FOODS

MARKET

Nighttime

Sleep-Aid

Diphenhydramine HCl

Capsules USP, 50 mg

Maximum Strength

Fall asleep fast & Sleep Soundly

safe, non habit-forming

**Compare to the A ctive Ingredient in Unisom® SleepGels®

One softgel per dose

32

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)

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 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


Raw Label Data

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