LEADER MAXIMUM STRENGTH SLEEP AID  - diphenhydramine hydrochloride capsule, liquid filled 
Cardinal Health

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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Leader Nighttime Sleep Aid Maximum Strength

Active Ingredient (in each softgel)

Diphenhydramine HCl 50mg

Purpose

Nighttime sleep aid

Use

helps to reduce difficulty falling asleep

Warnings

Do not give to children under 12 years of age


Do not use this product

with other products containing diphenhydramine, even one used on skin.

Ask a doctor or pharmacist before use if you have

emphysema

chronic bronchitis

glaucoma

difficulty in urination due to an enlargement of the prostate gland

When using this product

avoid alcoholic beverages.

Stop use and ask a doctor if

sleeplessness persists 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

adults and children 12 years of age and over: take 1 softgel at bedtime if needed or as
directed by a doctor

Other information



KEEP OUTER CARTON FOR COMPLETE
WARNINGS AND PRODUCT INFORMATION

edible white ink, FDandC Blue #1, gelatin, glycerin, polyethylene glycol, purified water and sorbitol special.

Questions or comments?

Call toll free: 1-800-200-6313

Distributed by:
Cardinal Health
Dublin, Ohio 43017

All Leader Brand Products are 100% satisfation guaranteed or return to place of purchase for a full refund

*Compare to Maximum Strength Unisom® SleepGels®

NDC 37205-0120-64

Maximum Strength Sleep Aid

Diphenhydramine HCl

Helps to reduce difficulty falling asleep

32 softgels

Container Label

Nighttime Sleep Aid

Outer Carton Label

Nighttime Sleep Aid

LEADER MAXIMUM STRENGTH SLEEP AID  
diphenhydramine hydrochloride capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37205-120
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE50 mg
Inactive Ingredients
Ingredient NameStrength
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
Product Characteristics
Colorblue (BLUE) Scoreno score
ShapeOVAL (OVAL) Size13mm
FlavorImprint Code P50;A99
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:37205-120-641 in 1 BOX
132 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33806/05/2012
Labeler - Cardinal Health (097537435)

Revised: 6/2012
Document Id: 15d8a696-015f-4cd2-911d-9f93bf80ff6f
Set id: 40f5c41b-bd03-4aa8-8d56-0de1111946b5
Version: 5
Effective Time: 20120607
 
Cardinal Health