Search by Drug Name or NDC

NDC 70000-0086-01 Sleep Aid 25 mg/1 Details

Sleep Aid 25 mg/1

Sleep Aid is a ORAL CAPSULE, LIQUID FILLED in the HUMAN OTC DRUG category. It is labeled and distributed by Cardinal Health 110, LLC. DBA Leader. The primary component is DIPHENHYDRAMINE HYDROCHLORIDE.

MedlinePlus Drug Summary

Diphenhydramine is used to relieve red, irritated, itchy, watery eyes; sneezing; and runny nose caused by hay fever, allergies, or the common cold. Diphenhydramine is also used to relieve cough caused by minor throat or airway irritation. Diphenhydramine is also used to prevent and treat motion sickness, and to treat insomnia (difficulty falling asleep or staying asleep). Diphenhydramine is also used to control abnormal movements in people who have early stage parkinsonian syndrome (a disorder of the nervous system that causes difficulties with movement, muscle control, and balance) or who are experiencing movement problems as a side effect of a medication. Diphenhydramine will relieve the symptoms of these conditions but will not treat the cause of the symptoms or speed recovery. Diphenhydramine should not be used to cause sleepiness in children. Diphenhydramine is in a class of medications called antihistamines. It works by blocking the action of histamine, a substance in the body that causes allergic symptoms.

Related Packages: 70000-0086-01
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Diphenhydramine

Product Information

NDC	70000-0086
Product ID	70000-0086_7dee07d9-e66e-4ff8-9867-1d4ec1f71520
Associated GPIs	60300020100105
GCN Sequence Number	068767
GCN Sequence Number Description	diphenhydramine HCl CAPSULE 25 MG ORAL
HIC3	H2E
HIC3 Description	SEDATIVE-HYPNOTICS,NON-BARBITURATE
GCN	31607
HICL Sequence Number	004480
HICL Sequence Number Description	DIPHENHYDRAMINE HCL
Brand/Generic	Generic
Proprietary Name	Sleep Aid
Proprietary Name Suffix	n/a
Non-Proprietary Name	Diphenhydramine HCl
Product Type	HUMAN OTC DRUG
Dosage Form	CAPSULE, LIQUID FILLED
Route	ORAL
Active Ingredient Strength	25
Active Ingredient Units	mg/1
Substance Name	DIPHENHYDRAMINE HYDROCHLORIDE
Labeler Name	Cardinal Health 110, LLC. DBA Leader
Pharmaceutical Class	Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part338
Listing Certified Through	n/a

Package

Package Images

NDC 70000-0086-01 (70000008601)

Pricing Information	N/A
NDC Package Code	70000-0086-1
Billing NDC	70000008601
Package	1 BLISTER PACK in 1 CARTON (70000-0086-1) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
Marketing Start Date	2021-03-04
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 9e6cc5c4-2476-465b-b9a8-f0816183fbda Details

Active ingredient (in each liquid-filled capsule)

Diphenhydramine HCl 25 mg

Purpose

Nighttime sleep-aid

Uses

for 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

glaucoma
a breathing problem such as emphysema or chronic bronchitis
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 a 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

do not take more than directed
take only one dose per day (24 hours)
adults and children 12 years and over: take 2 capsules at bedtime if needed or as directed by a doctor
children under 12 years: do not use

Other information

TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
protect from light, heat and moisture
store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
see end flap for expiration date and lot number

Inactive ingredients

FD&C blue #1, FD&C red #40, gelatin, glycerin, isopropyl alcohol, medium chain triglycerides, polyethylene glycol, povidone, purified water, sorbitol sorbitan solution, white ink

Questions or comments?

1-800-426-9391

Principal display panel

NDC 70000-0086-1

LEADER™

Sleep-Aid

Diphenhydramine HCl, 25 mg

Nighttime Sleep-Aid

Non-Habit Forming

Helps You Fall Asleep

Not for Treating Pain, Cold or Flu

Actual Size

12 LIQUID GELS**

**Liquid-Filled Capsules

COMPARE TO VICKS® ZZZQUIL® NIGHTTIME SLEEP-AID LIQUICAPS® active ingredient*

100% Money Back Guarantee

*This product is not manufactured or distributed by The Procter & Gamble Company, owner of the registered trademark

VICKS® ZzzQuil® NIGHTTIME SLEEP-AID LiquiCaps®.

Product of Dubai

Packaged and Quality Assured in the USA

50844 ORG012072702

CardinalHealth™

DISTRIBUTED BY:CARDINAL HEALTH

DUBLIN, OHIO 43017

www.myleader.com 1-800-200-6313

Essential to Care™ since 1979

All LEADERTM Brand Products Have A

100% Money Back Guarantee

Return to place of purchase if not satisfied

©2021 Cardinal Health. All Rights Reserved. CARDINAL HEALTH, the Cardinal Health LOGO, ESSENTIAL TO CARE, LEADER, and the Leader LOGO are trademarks or registered trademarks of Cardinal Health. All other marks are the property of their respective owners.

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER

UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

Leader 44-727

INGREDIENTS AND APPEARANCE

SLEEP AID

diphenhydramine hcl capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70000-0086
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	25 mg

Ingredient Name	Strength
Inactive Ingredients
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
SORBITAN (UNII: 6O92ICV9RU)

Product Characteristics
Color	purple	Score	no score
Shape	OVAL	Size	16mm
Flavor		Imprint Code	727
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:70000-0086-1	1 in 1 CARTON	03/04/2021	05/25/2023
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	03/04/2021	05/25/2023

Labeler - Cardinal Health 110, LLC. DBA Leader (063997360)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		832867837	pack(70000-0086)

Revised: 7/2022

Document Id: 7dee07d9-e66e-4ff8-9867-1d4ec1f71520

Set id: 9e6cc5c4-2476-465b-b9a8-f0816183fbda

Version: 5

Effective Time: 20220714