NIGHTTIME SLEEP AID- acetaminophen, diphenhydramine tablet 
Hi-Tech Nutraceuticals, LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Sleep Aid

actives

ask a doc

ask a doc or pharm

do not use

keep out of reach

pregnancy

Purpose

Questions

stop use

when using

Overdose

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inactives

uses

storage

directions

pdp

NIGHTTIME SLEEP AID 
acetaminophen, diphenhydramine tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69732-005
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
Inactive Ingredients
Ingredient NameStrength
SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
Product Characteristics
ColorwhiteScorescore with uneven pieces
ShapeCAPSULESize19mm
FlavorImprint Code HTP525
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69732-005-0130 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/30/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34304/30/2020
Labeler - Hi-Tech Nutraceuticals, LLC (606221443)
Establishment
NameAddressID/FEIBusiness Operations
Hi-Tech Nutraceuticals, LLC080787135pack(69732-005)
Establishment
NameAddressID/FEIBusiness Operations
Hi-Tech Nutraceuticals, LLC606221443manufacture(69732-005)

Revised: 12/2022
Document Id: f11c9344-b729-4cb2-e053-2a95a90aa8a0
Set id: a39e2bd6-3d0a-642b-e053-2995a90a42a0
Version: 3
Effective Time: 20221231
 
Hi-Tech Nutraceuticals, LLC