SLEEP-AID MAXIMUM STRENGTH- diphenhydramine hcl capsule 
ASSURED / DOLLAR TREE (Greenbrier International, 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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DRUG FACTS

Active ingredient (in each softgel)

Diphenhydramine HCl 50 mg

Purpose

Nighttime sleep-aid

Use

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 before use if you have

  • emphysema
  • chronic bronchitis
  • glaucoma
  • difficulty in urination due to an enlargement of the prostate gland

Ask a doctor or pharmacist before use if you are now 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

Other information

Questions or comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Inactive ingredients

edible white ink, FD&C blue #1, gelatin, glycerin, polyethylene glycol, purified water and sorbitol special

Principal Display Panel

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

Maximum Strength Sleep-Aid

Diphenhydramine HCl

Helps to reduce difficulty falling asleep

50 mg EACH

SOFTGELS

Distributed by:

Greenbrier International, Inc.

Chesapeake, VA 23320

THIS PRODUCT IS SEALED IN A CHILD RESISTANT AND TAMPER EVIDENT PACKAGE. USE ONLY IF BLISTERS ARE INTACT.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

*This product is not manufactured or distributed by Chattem, Inc., owner of the registered trademark Maximum Strength Unisom® SleepGels®.

Product Label

Diphenhydramine, 50 mg

Assured Maximum Strength Sleep-Aid

SLEEP-AID  MAXIMUM STRENGTH
diphenhydramine hcl capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:33992-2300
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)  
SORBITAN (UNII: 6O92ICV9RU)  
Product Characteristics
ColorBLUEScoreno score
ShapeCAPSULESize13mm
FlavorImprint Code P50;A99
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:33992-2300-81 in 1 CARTON
18 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34107/06/2010
Labeler - ASSURED / DOLLAR TREE (Greenbrier International, Inc.) (610322518)
Registrant - P and L Development of New York Corporation (800014821)

Revised: 3/2013
Document Id: 2fe02208-dc55-4086-ac3f-fff1196d2144
Set id: 136d605a-f9dd-4553-b59f-3e9e2eb1dc43
Version: 2
Effective Time: 20130314
 
ASSURED / DOLLAR TREE (Greenbrier International, Inc.)