DIPHENHYDRAMINE HYDROCHLORIDE 50MG capsule, liquid filled

DIPHENHYDRAMINE HYDROCHLORIDE 50mg by

Drug Labeling and Warnings

DIPHENHYDRAMINE HYDROCHLORIDE 50mg by is a Otc medication manufactured, distributed, or labeled by AMZ789 LLC, Nutra-Med Packaging Inc., Humanwell Puracap Pharmaceuticals (Wuhan) Co., Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

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

INACTIVE INGREDIENT

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

PRINCIPAL DISPLAY PANEL

RxZell

SleepAid

Dyphenhydramine HCl 50mg

Non Habit-Forming

Easy to Swallow

Package.Label Principal Display Panel

INGREDIENTS AND APPEARANCE

DIPHENHYDRAMINE HYDROCHLORIDE 50MG 
diphenhydramine hydrochloride 50mg capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73629-001
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	50 mg

Inactive Ingredients
Ingredient Name	Strength
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
Color	blue (clear)	Score	no score
Shape	OVAL	Size	13mm
Flavor		Imprint Code	PC13
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73629-001-22	220 in 1 BOTTLE; Type 0: Not a Combination Product	09/28/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part338	09/21/2020

Labeler - AMZ789 LLC (117410213)

Establishment
Name	Address	ID/FEI	Business Operations
Nutra-Med Packaging Inc.		022004902	pack(73629-001)

Establishment
Name	Address	ID/FEI	Business Operations
Humanwell Puracap Pharmaceuticals (Wuhan) Co., Ltd		421293287	manufacture(73629-001) , analysis(73629-001)