NIGHTTIME SLEEP AID- diphenhydramine hcl tablet

NIGHTTIME SLEEP AID by

Drug Labeling and Warnings

NIGHTTIME SLEEP AID by is a Otc medication manufactured, distributed, or labeled by Bi-Mart, Elysium Pharmaceutical Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient (in each caplet)

Diphenhydramine HCl 25 mg

Purpose

Nighttime sleep-aid

Use

help reduce difficult falling asleep

Warnings

Do not use

• in children under 12 years of age
• with any other products containing diphenhydramine, even one used on skin
• with other antihistamines

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.

When using this product

• avoid alcoholic beverages
• be careful when driveing 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.

In case of accidental 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 older: take 2 caplets at bedtime if needed or as directed by a doctor

Other Information

• each caplet contains:calcium 30 mg

• each caplet contains:phosphorus 15 mg

• store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)

• protect from moisture

Inactive Ingredients

Briliant Blue Lack, Colloidal Silicon Dioxide, Croscarmellose Sodium, Dicalcium Phosphate, Indigo Carmine Lake, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Polyvinyl Alcohol, Stearic Acid, Talc, Titanium Dioxide

Questions?

Call toll-free 1-844-912-4012

SPL UNCLASSIFIED SECTION

Distributed by:

BI-MART

Eugene, OR 97402

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

NIGHTTIME SLEEP AID 
diphenhydramine hcl tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 37835-812
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
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
POLYVINYL ALCOHOL (UNII: 532B59J990)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
TALC (UNII: 7SEV7J4R1U)
STEARIC ACID (UNII: 4ELV7Z65AP)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 37835-812-36	36 in 1 BOTTLE; Type 0: Not a Combination Product	05/01/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	05/01/2025

Labeler - Bi-Mart (027630078)

Registrant - Bi-Mart (027630078)

Establishment
Name	Address	ID/FEI	Business Operations
Elysium Pharmaceutical Ltd.		915664486	manufacture(37835-812)