NIGHTTIME SLEEP-AID- diphenhydramine hcl capsule, liquid filled 
AMERISOURCE BERGEN

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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.

READ AND KEEP CARTON FOR COMPLETE WARNINGS AND INFORMATION

Made in USA using domestic and imported materials.

This product is not manufactured or distributed by the

owners of Unisom ® SleepGels ®.

Lot No.:

Exp. Date:

Distributed By
AmerisourceBergen
1 West First Ave
Conshohocken, PA 19428
Questions or Concerns?
www.mygnp.com

L0000442

Rev # 04/21

60's Count Carton

GOOD

NEIGHBOR

PHARMACY®

Compare to the active ingredient in Unisom® SleepGels®†

NDC 46122-695-72

Maximum Strength

Nighttime Sleep-aid

Diphenhydramine HCl Capsules, 50 mg

Fall Asleep Fast
• sleep soundly • safe, non-habit forming

One Softgel Per Dose

60 softgels** I (**Liquid-filled capsules)

60's Carton

NIGHTTIME SLEEP-AID 
diphenhydramine hcl capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:46122-695
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
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
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:46122-695-721 in 1 CARTON07/15/2021
160 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01007/15/2021
Labeler - AMERISOURCE BERGEN (007914906)
Registrant - Bionpharma Inc. (079637826)
Establishment
NameAddressID/FEIBusiness Operations
Patheon Softgels Inc.002193829manufacture(46122-695)

Revised: 10/2023
Document Id: 0762f686-d0ef-cd1f-e063-6394a90a2af9
Set id: ca052b38-de38-7bf0-e053-2995a90a4e85
Version: 3
Effective Time: 20231010
 
AMERISOURCE BERGEN