MAXIMUM STRENGTH SLEEP AID- diphenhydramine hcl capsule, gelatin coated 
SPIRIT PHARMACEUTICALS LLC

----------

ASSURED™ MAXIMUM STRENGTH SLEEP AID

Drug Facts

Active ingredient (in each softgel)                           

Diphenhydramine HCl 50 mg

Purpose

Nighttime sleep-aid

Use

for the relief of occasional sleeplessness

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

  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • trouble urinating due to an enlarged prostate gland

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers

Stop use and ask a doctor if

sleeplessness persist continuosly for more than 2 weeks. Insomnia may be a symptom of 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. 1-800-222-1222

Directions

  • adults and children 12 years of age and over: 1 softgel (50 mg) at bedtime, if needed, or as directed by a doctor

Inactive ingredients

FD&C Blue#1, gelatin, glycerin, polyethylene glycol-400, propylene glycol, sorbitol, titanium dioxide, water

Questions or comments?

1-888-333-9792

DISTRIBUTED BY
GREENBRIER INTERNATIONAL, INC.
500 VOLVO PARKWAY, CHESAPEAKE, VA 23320

PRINCIPAL DISPLAY PANEL - 8 softgels Bottle Carton

ASSURED™

MAXIMUM STRENGTH

SLEEP AID

  • Diphenhydramine HCl 50 mg

     Nighttime Sleep-Aid

Helps reduce difficulty falling asleep

Fast acting, Non-habit forming

Actual Size

8 softgels

PRINCIPAL DISPLAY PANEL - 8 softgels Bottle Carton

MAXIMUM STRENGTH SLEEP AID 
diphenhydramine hcl capsule, gelatin coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68210-0202
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 400 (UNII: B697894SGQ)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SORBITOL (UNII: 506T60A25R)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
ColorblueScoreno score
ShapeOVALSize13mm
FlavorImprint Code 206
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68210-0202-81 in 1 CARTON03/15/2018
18 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01003/15/201812/08/2023
Labeler - SPIRIT PHARMACEUTICALS LLC (179621011)

Revised: 12/2023
Document Id: 0c019128-f66e-84ef-e063-6294a90ab808
Set id: 14b6a495-4516-4ed6-90dc-d1009b7de310
Version: 6
Effective Time: 20231208
 
SPIRIT PHARMACEUTICALS LLC