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 WALGREEN COMPANY, Shield Pharmaceuticals Corp, Bajaj Nutraceuticals. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients (in each softgel)

Diphenhydramine HCl 25 mg

Purpose

nighttime sleep-aid

Uses

• for the relief of occasional sleeplessness
• reduces time to fall asleep if you have difficulty falling asleep

WARNINGS

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 asthma, emphysema, or chronic bronchitis
• glaucoma
• difficulty in urination due to enlargement of the prostate gland
• heart disease

Ask a doctor or pharmacist before use if you aretaking sedatives, tranquilizers or any other sleep aid

When using this product

• avoid alcoholic beverages and other drugs that cause drowsiness
• drowsiness will occur
• be careful when driving a motor vehicle or operating machinery

Stop use and ask a doctor ifsleeplessness persists 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.Overdose warning: Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away. 1(800)222-1222

Directions

• take only one dose per day (24 hours) - see Overdose warning

• adults & children 12 yrs & over: One dose=TWO 25 mg softgels (50 mg) at bed time if needed or as directed by a doctor
• children under 12 years: Do not use

Other information

• store at 20-25°C (68-77°F)
• avoid excessive heat above 40°C (104°F) and high humidity
• Protect from light

Inactive ingredients

FD&C Blue No. 1, FD&C Red No. 40, gelatin, glycerin, propylene glycol, polyethylene glycol-400, povidone, purified water, sorbitol sorbitan solution

Questions or comments?

1-800-373-6981

QUESTIONS

Distributed by: Walgreen co.
200 Wilmot rd., Deerfield, IL 60015

PRINCIPAL DISPLAY PANEL

Compare to the active ingredient in ZzzQuil®*

NIGHTTIME SLEEP-AID

DIPHENHYDRAMINE HCl 25 mg

INGREDIENTS AND APPEARANCE

NIGHTTIME SLEEP AID 
diphenhydramine hydrochloride capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0363-1174
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	25 mg

Inactive Ingredients
Ingredient Name	Strength
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
POVIDONE (UNII: FZ989GH94E)
SORBITOL SOLUTION (UNII: 8KW3E207O2)
SORBITAN (UNII: 6O92ICV9RU)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	purple	Score	no score
Shape	CAPSULE (OBLONG)	Size	15mm
Flavor		Imprint Code	SD13
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0363-1174-24	2 in 1 CARTON	10/21/2023
1		12 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 0363-1174-48	4 in 1 CARTON	10/21/2023
2		12 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	505G(a)(3)	10/21/2023

Labeler - WALGREEN COMPANY (008965063)

Registrant - Shield Pharmaceuticals Corp (118724924)

Establishment
Name	Address	ID/FEI	Business Operations
Bajaj Nutraceuticals		871418313	manufacture(0363-1174)