NIGHTTIME SLEEP AID MAXIMUM STRENGTH- diphenhydramine hydrochloride capsule, liquid filled 
P & L Development, LLC

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 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 are not taking

sedatives or tranquilizers.

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

  • store at controlled room temperature 15°-30°C (59°-86°F)
  • do not use if imprinted safety seal under cap is broken or missing
  • *This product is not manufactured or distributed by Chattem, Inc., owner of the registered trademark Maximum Strength Unisom® SleepGels®.

KEEP OUTER CARTON FOR COMPLETE
WARNINGS AND PRODUCT INFORMATION

Inactve ingredients

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

Questions or comments?

Call toll free: 1-877-753-3935


Distributed by:
PL Developments
Westbury, NY 11590, USA

Principal Display Panel

*Compare to the active ingredient in Maximum Strength Unisom® SleepGels®

NDC 59726-230-32

Nighttime Sleep Aid

Maximum Strength

Diphenhydramine HCl

Helps to reduce difficulty falling asleep

50mg EACH

32 softgels

Container Label

Nighttime Sleep Aid

Outer Carton Label

Nighttime Sleep Aid
NIGHTTIME SLEEP AID MAXIMUM STRENGTH 
diphenhydramine hydrochloride capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59726-230
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 GLYCOL 1000 (UNII: U076Q6Q621)  
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
Product Characteristics
ColorBLUE (BLUE) Scoreno score
ShapeOVAL (OVAL) Size13mm
FlavorImprint Code P50
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59726-230-321 in 1 BOX
132 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33809/02/201112/31/2016
Labeler - P & L Development, LLC (800014821)

Revised: 3/2016
Document Id: 3de8e2f2-06c6-4630-b22d-24bda1d23ce5
Set id: 9e83c49a-64d6-4f10-b1ae-ef41ef461d1c
Version: 6
Effective Time: 20160301
 
P & L Development, LLC