NIGHTTIME SLEEP-AID SOFTGEL- diphenhydramine hydrochloride 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.

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Nighttime Sleep-Aid

Diphenhydramine HCl Softgels, 25 mg (purple)

Drug Facts

Active ingredients (in each softgel)

Diphenhydramine HCl 25 mg

Purpose

Nighttime sleep-aid

Uses

for the relief of occasional sleeplessness
reduces time to fall asleep if you have difficulty falling asleep

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
difficulty in urination due to enlargement of the prostate gland

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers

When using this product

avoid alcoholic beverages

Stop use and ask a doctor if

sleeplessness persists 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.

Keep out of reach of children. Overdose warning: Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

take only one dose per day (24 hours) - see Overdose warning

adults & children 12 yrs & over	2 softgels at bed time if needed or as directed by a doctor
children under 12 yrs	do not use

Other information

store at 20-25° C (68-77° F).
avoid excessive heat above 40° C (104° F).
Protect from light.

TEMPER EVIDENT: This package is safety sealed & child resistant. Use only if blisters are intact. If difficult to open, use scissors.

Inactive ingredients

FD&C blue #1, FD&C red# 40, 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 Monday through Friday 9AM - 5PM EST.

PRINCIPAL DISPLAY PANEL

NDC: 11788-026-12

NIGHTTIME SLEEP-AID
Diphenhydramine HCl

Manufactured for:

AiPing Pharmaceutical, Inc.

Hauppauge, NY 11788

Manufactured by:

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

diphen purple

NIGHTTIME SLEEP-AID SOFTGEL
diphenhydramine hydrochloride capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:11788-026
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 in 2

Ingredient Name	Strength
Inactive Ingredients
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
FD&C RED NO. 40 (UNII: WZB9127XOA)
SORBITOL (UNII: 506T60A25R)

Product Characteristics
Color	purple	Score	no score
Shape	CAPSULE	Size	14mm
Flavor		Imprint Code	AP026
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:11788-026-12	1 in 1 CARTON	01/31/2015
1		12 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part338	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(11788-026)

Revised: 5/2021

Document Id: c3296e69-f131-72c0-e053-2a95a90a1be2

Set id: 81da7e81-bfc8-4237-9520-f9ee5ea557cc

Version: 5

Effective Time: 20210525