NIGHTTIME SLEEP AID- diphenhydramine hcl tablet, coated

Nighttime Sleep Aid by

Drug Labeling and Warnings

Nighttime Sleep Aid by is a Otc medication manufactured, distributed, or labeled by HealthLife of USA LLC, ELYSIUM PHARMACEUTICALS LIMITED, HHH PHARMA USA LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each caplet)

Diphenhydramine HCl 25 mg

Purpose

Nighttime sleep-aid

Uses:

• 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
• with other drugs that cause drowsiness such as antihistamines and nighttime cold/flu products

ask a doctor before use if you have

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

• heart disease

ask your doctor or pharmacist before use if you are

• taking sedative or tranquilizers or any other sleep-aid

When using this product

• drowsiness will occur
• avoid alcoholic beverages and other drugs that cause drowsiness
• excitability may occur, especially in children
• alcohol, sedatives and tranquilizers may increase drowsiness
• be careful when driving a motor vehicle or operating machinery

Stop use and ask a doctor if

sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a 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 (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms

Directions

• do not take more than directed(see overdose warning)
• adults and children 12 years of age and over:- take 2 caplets at bedtime if needed or as directed by a doctor
• children under 12 years of age:do not use

Other Information

• Each caplet contains: Calcium 23.52 mg
• store at controlled room temperature 25°C (77°F); excursions permitted between 15-30°C (59-86°F)
• read all product information before using

Inactive Ingredients

Colloidal Silicon Dioxide, Croscarmellose Sodium, Dicalcium Phosphate, Magnesium Stearate, Microcrystalline Cellulose (PH-102), Titanium dioxide, Brilliant Blue FCF Aluminum lack (FD&C Blue No. 1), Indico Carmel lake (FD&C Blue No. 2).

Questions or comments?

Call 1-844-832-1138

9AM – 5PM Monday - Friday

Principal Display Panel-300 Caplets

Principal Display Panel-600 Caplets

Principal Display Panel-1000 Caplets

INGREDIENTS AND APPEARANCE

NIGHTTIME SLEEP AID 
diphenhydramine hcl tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69517-004
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
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE (UNII: 70097M6I30)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	blue	Score	no score
Shape	CAPSULE	Size	11mm
Flavor		Imprint Code	S25
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69517-004-03	300 in 1 BOTTLE; Type 0: Not a Combination Product	09/25/2025
2	NDC: 69517-004-06	600 in 1 BOTTLE; Type 0: Not a Combination Product	09/25/2025
3	NDC: 69517-004-10	1000 in 1 BOTTLE; Type 0: Not a Combination Product	09/25/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M010	09/25/2025

Labeler - HealthLife of USA LLC (079656178)

Registrant - HealthLife of USA LLC (079656178)

Establishment
Name	Address	ID/FEI	Business Operations
ELYSIUM PHARMACEUTICALS LIMITED		863182240	manufacture(69517-004)

Establishment
Name	Address	ID/FEI	Business Operations
HHH PHARMA USA LLC		062788820	pack(69517-004)