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

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Diphenhydramine HCl 50mg, Amerisource Bergen, Made in India

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

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)

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

Distributed By

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

ABC#: 10287782 Rev: 04/24

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

Mfg. Lic. No.: TN00002123

Made in India

T00186R0324

L0000797

R0324

Lot No.:
Exp. Date:

60's count

Compare to the active ingredient in Unisom® SleepGels®

NDC 46122-775-64

GOOD

NEIGHBOR

PHARMACY

Maximum Strength

Nighttime Sleep-Aid

Diphenhydramine HCl Capsules, USP 50 mg

Fall Asleep Fast

• sleep soundly • safe, non-habit forming

One Softgel Per Dose

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

image001

NIGHTTIME SLEEP-AID 
diphenhydramine hcl capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:46122-775
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
POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)  
SORBITAN (UNII: 6O92ICV9RU)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
GELATIN (UNII: 2G86QN327L)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SORBITOL (UNII: 506T60A25R)  
Product Characteristics
ColorblueScoreno score
ShapeOVALSize13mm
FlavorImprint Code B50
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:46122-775-641 in 1 CARTON04/11/2024
160 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01004/11/2024
Labeler - AMERISOURCE BERGEN (007914906)
Registrant - Bionpharma Inc. (079637826)
Establishment
NameAddressID/FEIBusiness Operations
SOFTGEL HEALTHCARE PRIVATE LIMITED675584180manufacture(46122-775)

Revised: 4/2024
Document Id: 16b2ed06-4c39-d6c4-e063-6294a90aed8f
Set id: 16b2edd2-c16b-5713-e063-6394a90acf46
Version: 1
Effective Time: 20240422
 
AMERISOURCE BERGEN