NIGHTTIME SLEEP-AID- diphenhydramine hcl capsule, liquid filled 
BIONPHARMA INC.

----------

Diphenhydramine HCl 50mg, A+ Health, Made in India

Active ingredient (in each capsule)

Diphenhydramine HCl 50 mg

Purpose

Nighttime sleep-aid

Uses

Warnings

Do not use

Ask a doctor before use if you have

Ask a doctor or pharmacist before use

if you are taking sedatives or tranquilizers.

When using this product

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 Centre right away.

Directions

Other information

Inactive ingredients

FD&C blue #1, gelatin, glycerin, polyethylene glycol 400, polyethylene glycol 600, propylene glycol, purified water, sorbitol sorbitan solution

Questions or comments?

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 ®.

Manufactured for:

Bionpharma Inc.

Princeton, NJ 08540

Made in India

L0000778

R0124

Mfg. Lic. No.: TN00002123

2620515

Lot No.:

Exp. Date:

160's count

Compare to the active ingredient in Unisom ®SleepGels ®

NDC 69452-427-79

a+ health

maximum strength

nighttime

sleep-aid

diphenhydramine HCl capsules USP, 50 mg

fall asleep fast

sleep soundly

safe, non-habit

forming

one softgel per dose

160 softgels**

**liquid-filled capsules

image001

image002

NIGHTTIME SLEEP-AID 
diphenhydramine hcl capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69452-427
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:69452-427-79160 in 1 BOTTLE; Type 0: Not a Combination Product03/21/2024
2NDC:69452-427-1760 in 1 BOTTLE; Type 0: Not a Combination Product03/21/2024
3NDC:69452-427-1032 in 1 BOTTLE; Type 0: Not a Combination Product03/21/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01003/21/2024
Labeler - BIONPHARMA INC. (079637826)
Registrant - Bionpharma Inc. (079637826)
Establishment
NameAddressID/FEIBusiness Operations
SOFTGEL HEALTHCARE PRIVATE LIMITED675584180manufacture(69452-427)

Revised: 3/2024
Document Id: 141b0ea5-32cf-4831-e063-6294a90abc28
Set id: 141b00b7-a283-40ab-e063-6294a90aec77
Version: 1
Effective Time: 20240321
 
BIONPHARMA INC.