NIGHTTIME SLEEP AID- diphenhydramine hydrochloride capsule, liquid filled 
Shield Pharmaceuticals Corp

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Nighttime Sleep Aid

Drug Facts

Active ingredient (in each softgel)

Diphenhydramine HCl 50 mg

Purpose

Nighttime sleep-aid

Uses

• for 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 useif you are taking sedatives or tranquilizers

When using this product avoid alcoholic drinks

Stop use and ask a doctor if
sleeplessness persist continuously 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 (1-800-222-1222) right away.

Directions

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

Other information

• store at controlled room temperature 20-25ºC (68-77ºF)
• protect from light, heat and moisture

Inactive ingredients

FD&C Blue #1, gelatin, glycerine, polyethylene glycol 400, propylene glycol, sorbitan

Questions or comments?

1-800-373-6981

Distributed by:
Shield Pharmaceuticals Corp.
Hauppauge, NY 11788

PRINCIPAL DISPLAY PANEL

Compare to the active ingredient in Unisom® SleepGels

Sleep-Aid

Diphenhydramine HCI Softgels, 50 mg


Carton

Nighttime Sleep Aid Carton

NIGHTTIME SLEEP AID 
diphenhydramine hydrochloride capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83059-0028
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)  
SORBITAN (UNII: 6O92ICV9RU)  
Product Characteristics
ColorblueScoreno score
ShapeCAPSULESize13mm
FlavorImprint Code SD28
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:83059-0028-81 in 1 CARTON04/08/2024
18 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01004/08/2024
Labeler - Shield Pharmaceuticals Corp (118724924)

Revised: 4/2024
Document Id: 159c6ff1-2374-bf96-e063-6394a90afcc3
Set id: ab825826-d911-4a0f-9d5c-5ee2f242b893
Version: 2
Effective Time: 20240408
 
Shield Pharmaceuticals Corp