DIPHENHYDRAMINE HCL- diphenhydramine hcl capsule, liquid filled
AiPing Pharmaceutical, Inc.

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.

----------

Nighttime Sleep Aid

Diphenhydramine HCl Softgels, USP 50 mg

Drug Facts

Active ingredient (in each softgel)

Diphenhydramine HCI 50 mg

Purpose

Nighttime sleep-aid

Use

for relief of occasional sleeplessness

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

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

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers

When using this product

avoid alcoholic drinks

Stop use and ask a doctor if

sleeplessness persist continuously for more than 2 weeks. 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: 1 softgel (50 mg) at bedtime if needed, or as directed by a doctor

Other Information

store between 20-25°C (68-77°F). Avoid high humidity and excessive heat. Protect from light.

ATTENTION: DO NOT USE IF IMPRINTED SEAL UNDER CAP IS MISSING OR BROKEN. CHILD- RESISTANT PACKAGING.

Inactive ingredients

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

Questions or comments?

Call toll free 1-844-374-0016

PRINCIPAL DISPLAY PANEL

NDC: 11788-018-32

* Compare to UNISOM ® SLEEPGELS ® Active Ingredient

* This product is not manufactured by Chattem, Inc., distributor of Unisom ®

Manufactured for:

AiPing Pharmaceutical, Inc.

Hauppauge, NY 11788

Manufactured by:

Anshi Pharmaceutical (Zhongshan) Inc., P.R.China

Diphen 50mg

DIPHENHYDRAMINE HCL
diphenhydramine hcl capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:11788-018
Route of Administration	ORAL

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

Ingredient Name	Strength
Inactive Ingredients
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
SORBITOL (UNII: 506T60A25R)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	blue	Score	no score
Shape	CAPSULE	Size	14mm
Flavor		Imprint Code	AP018
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:11788-018-32	1 in 1 CARTON	01/31/2015
1		32 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	01/31/2015	12/31/2019

Labeler - AiPing Pharmaceutical, Inc. (079674526)

Registrant - AiPing Pharmaceutical, Inc. (079674526)

Name	Address	ID/FEI	Business Operations
Establishment
Anshi Pharmaceutical (Zhongshan) Inc.		528101821	manufacture(11788-018)

Revised: 5/2021

Document Id: c3297a36-46ef-7120-e053-2a95a90a00ba

Set id: 26c3aebe-ab4c-4925-bd58-8dec48de048a

Version: 4

Effective Time: 20210525