NIGHTTIME SLEEP-AID- diphenhydramine hcl capsule, liquid filled

Nighttime Sleep-Aid by

Drug Labeling and Warnings

Nighttime Sleep-Aid by is a Otc medication manufactured, distributed, or labeled by Whole Foods Market, INC., Bionpharma Inc., SOFTGEL HEALTHCARE PRIVATE LIMITED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each capsule)

Diphenhydramine HCl 50 mg

Purpose

Nighttime sleep-aid

Uses

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

Warnings

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

■ 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.

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.

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: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)

SPL UNCLASSIFIED SECTION

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

L0000950 R0125

Mfg. Lic. No.: TN00002123

Lot No.:

Exp. Date:

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 Active Ingredient in Unisom® SleepGels®

One softgel per dose

32

SOFTGELS*

*Liquid-filled capsules

INGREDIENTS AND APPEARANCE

NIGHTTIME SLEEP-AID 
diphenhydramine hcl capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42681-0051
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	50 mg

Inactive Ingredients
Ingredient Name	Strength
POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)
SORBITAN (UNII: 6O92ICV9RU)
GELATIN (UNII: 2G86QN327L)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SORBITOL (UNII: 506T60A25R)

Product Characteristics
Color	white ((Clear Transparent))	Score	no score
Shape	OVAL	Size	13mm
Flavor		Imprint Code	DF50
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42681-0051-1	1 in 1 CARTON	05/21/2025
1		32 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M010	05/21/2025

Labeler - Whole Foods Market, INC. (196175616)

Registrant - Bionpharma Inc. (079637826)

Establishment
Name	Address	ID/FEI	Business Operations
SOFTGEL HEALTHCARE PRIVATE LIMITED		675584180	manufacture(42681-0051)