NIGHTTIME SLEEP AID- diphenhydramine hydrochloride capsule, liquid filled

Nighttime Sleep Aid by

Drug Labeling and Warnings

Nighttime Sleep Aid by is a Otc medication manufactured, distributed, or labeled by Shield Pharmaceuticals Corp. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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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

Do not use

for children under 12 years of age
with any other product containing diphenhydramine, even one used on skin

ASK DOCTOR

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 DOCTOR/PHARMACIST

Ask a doctor or pharmacist before useif you are taking sedatives or tranquilizers

WHEN USING

When using this product avoid alcoholic drinks

STOP USE

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.

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding,ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

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

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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

INGREDIENTS AND APPEARANCE

NIGHTTIME SLEEP AID 
diphenhydramine hydrochloride capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83059-0028
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	50 mg

Inactive Ingredients
Ingredient Name	Strength
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
Color	blue	Score	no score
Shape	CAPSULE	Size	13mm
Flavor		Imprint Code	SD28
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83059-0028-8	1 in 1 CARTON	04/08/2024
1		8 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M010	04/08/2024

Labeler - Shield Pharmaceuticals Corp (118724924)