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

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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

Inactive ingredients

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

Questions or comments?

1-888-333-9792

PRINCIPAL DISPLAY PANEL

SLEEP AID

Diphenhydramine HCl 50 mg
100 Softgels

image description

MAXIMUM STRENGTH SLEEP AID 
diphenhydramine hcl capsule, gelatin coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68210-4099
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;903
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68210-4099-1100 in 1 BOTTLE; Type 0: Not a Combination Product07/02/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01007/02/2020
Labeler - SPIRIT PHARMACEUTICALS LLC (179621011)

Revised: 12/2023
Document Id: 0bf2d007-20f2-feca-e063-6294a90a3ae7
Set id: cee5f4b1-613f-4e49-a29a-6d4c4bd5df18
Version: 5
Effective Time: 20231207
 
SPIRIT PHARMACEUTICALS LLC