SLEEP-AID DIPHENHYDRAMINE HCL- diphenhydramine hydrochloride capsule, liquid filled 
Cardinal Health 110, LLC. DBA Leader

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Sleep-Aid Diphenhydramine HCl

Drug Facts

Active ingredient (in each softgel)

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 •with other drugs that cause drowsiness such as antihistamines and nighttime cold/flu products

Ask a doctor before use if you have •glaucoma •heart diseases •a breathing problem such as emphysema, asthma, 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, tranquilizers, or any other sleep aid

When using this product •avoid alcoholic beverages and other drugs that cause drowsiness. Be careful when driving a motor vehicle or operating machinery.

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. Overdose warning: In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.

Directions

•take only one dose per day (24 hours)

 adults and children
12 years and over
 take 2 softgels at bedtime if needed
or as directed by a doctor
 children under 12 years do not use

Other information

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

Inactive ingredients

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

Questions or comments?

1-888-577-8033 Monday-Friday 8am-4pm EST

LEADER 

Non-Habit Forming

Not for Treating Pain, Cold or Flu

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®.

All LEADERTM Brand Products Have A 100% Money Back Guarantee
Return to place of purchase if not satisfied.

READ AND KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

CardinalHealth

DISTRIBUTED BY CARDINAL HEALTH 
DUBLIN, OHIO 43017
www.myleader.com          1-800-200-6313
Essential to Care™ since 1979

©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.

Product of UAE
Packaged and Quality Assured in the USA

TAMPER EVIDENT: DO NOT USE IF BLISTER UNIT IS TORN, BROKEN OR SHOWS SIGNS OF TAMPERING

Packaging

Cardi-1

SLEEP-AID DIPHENHYDRAMINE HCL 
diphenhydramine hydrochloride capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0584
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorpurpleScoreno score
ShapeOVAL (oblong) Size15mm
FlavorImprint Code 779
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70000-0584-11 in 1 CARTON09/15/2021
112 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01009/15/2021
Labeler - Cardinal Health 110, LLC. DBA Leader (063997360)

Revised: 1/2024
Document Id: c2495666-a137-4697-be2d-d905f7294746
Set id: 4283558d-62df-4297-bc85-a4e06681a920
Version: 3
Effective Time: 20240111
 
Cardinal Health 110, LLC. DBA Leader