NIGHTTIME SLEEP-AID- diphenhydramine hcl capsule, liquid filled 
Bionpharma Inc.

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Drug Facts

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 continuously 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 Centre 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

FD&C blue #1, gelatin, glycerin, hypromellose, lecithin, medium chain triglycerides, polyethylene glycol, propylene glycol, purified water, sorbitan, sorbitol, titanium dioxide

Questions or comments?

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

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

This product is not manufactured or distributed by the owners of Unisom ®SleepGels ®.

Made in USA using domestic and imported materials.

Manufactured for:
Bionpharma Inc.
Princeton, NJ 08540


R0223 Lot No.: Exp. Date

L0000704

160's count Label

Compare to the active ingredient in Unisom ®SleepGels ®

NDC 69452-322-79

a+health

maximum strength

nighttime
sleep-aid

diphenhydramine HCl capsules, 50 mg

• fall asleep fast
• sleep soundly
• safe, non-habit forming

160 softgels**

**liquid-filled capsules

one softgel per dose

front

back

NIGHTTIME SLEEP-AID 
diphenhydramine hcl capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69452-322
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE50 mg
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
GELATIN (UNII: 2G86QN327L)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
WATER (UNII: 059QF0KO0R)  
SORBITAN (UNII: 6O92ICV9RU)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
Product Characteristics
ColorblueScoreno score
ShapeOVALSize13mm
FlavorImprint Code P50
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69452-322-79160 in 1 BOTTLE; Type 0: Not a Combination Product04/27/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01004/27/2021
Labeler - Bionpharma Inc. (079637826)
Registrant - Bionpharma Inc. (079637826)
Establishment
NameAddressID/FEIBusiness Operations
Patheon Softgels Inc.002193829manufacture(69452-322)

Revised: 12/2023
Document Id: 0d63c644-46c2-b4c0-e063-6394a90a9dd3
Set id: c0074c77-287e-6c26-e053-2995a90a4d31
Version: 4
Effective Time: 20231226
 
Bionpharma Inc.