DIPHENHYDRAMINE HYDROCHLORIDE 50MG- diphenhydramine hydrochloride 50mg capsule, liquid filled 
AMZ789 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.

----------

diphenhydramine HCl 50mg softgels

Diphenhydramine HCl 50mg

Dipheyhydramine HCl 50mg

Use

For relief of occasional sleeplessness

for relied of occasional sleeplessness

Warnings

for children under 12 years of age

with any other products containing diphenhydramine, even one used on skin

Ask a doctor or pharmacist before use if

you have a breathing problem such as emphysema or chronic bronchitis, glaucoma, trouble urinating due to an enlarged prostate gland

you are taking sedatives or tranquilizers

When using this product

avoid alcholic drinks

Stop use and ask a doctor if

sleeplessness presists continuously for more than 2 weeks. Insomnic may be a symptom of a series underlying medical illness

If pregnant or breast-feeding

ask a health professional before use

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222)

Direction

adults and children 12 years and over: 1 softgel at bedtime if needed, or as directed by a doctor

FD&C blue #1, gelatin, glycerin, polyethylene glycol, purified water, sorbitol sorbitan solution, white ink

RxZell

SleepAid

Dyphenhydramine HCl 50mg

Non Habit-Forming

Easy to Swallow

Package.Label Principal Display Panel

Label

DIPHENHYDRAMINE HYDROCHLORIDE 50MG 
diphenhydramine hydrochloride 50mg capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73629-001
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, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
GLYCERIN (UNII: PDC6A3C0OX)  
GELATIN (UNII: 2G86QN327L)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Product Characteristics
Colorblue (clear) Scoreno score
ShapeOVALSize13mm
FlavorImprint Code PC13
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73629-001-22220 in 1 BOTTLE; Type 0: Not a Combination Product09/28/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33809/21/2020
Labeler - AMZ789 LLC (117410213)
Establishment
NameAddressID/FEIBusiness Operations
Nutra-Med Packaging Inc.022004902pack(73629-001)
Establishment
NameAddressID/FEIBusiness Operations
Humanwell Puracap Pharmaceuticals (Wuhan) Co., Ltd421293287manufacture(73629-001) , analysis(73629-001)

Revised: 1/2022
Document Id: d56f3af9-92ae-1525-e053-2a95a90aceb0
Set id: af0b1b08-e269-6399-e053-2a95a90ac12d
Version: 3
Effective Time: 20220112
 
AMZ789 LLC