NIGHT TIME SLEEP-AID- diphenhydramine hcl tablet

NIGHT TIME SLEEP-AID by

Drug Labeling and Warnings

NIGHT TIME SLEEP-AID by is a Otc medication manufactured, distributed, or labeled by Advanced Rx LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients (in each Caplet)

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

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
• difficulty in urination due to enlargement of the prostate gland

ASK DOCTOR/PHARMACIST

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers

WHEN USING

When using this product

• avoid alcoholic beverages

STOP USE

Stop use and ask a doctor if sleeplessness persists 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 right away.

Directions

take only one dose (2 Caplets) per day (24 hours)

• adults & children 12 yrs & over: 2 Caplets at bedtime if needed or as directed by a doctor
• children under 12 yrs: do not use

Other information

• store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
• read all product information before using
• TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSIN

Inactive ingredients

Microcrystalline Cellulose, Dicalcium Phosphate, Stearic Acid, Croscarmellose Sodium, Colloidal Silicon Dioxide, Hypromellose, Titanium Dioxide, Triacetin, FD&C Red No.40 Lake, FD&C Blue No.2 Aluminum Lake, Polysorbate.

Questions or comments

Call toll free 1-800-630-8895

Monday through Friday 9AM - 5PM EST

SPL UNCLASSIFIED SECTION

Distributed by:

Advanced Rx LLC

1942 NE 163rd St North Miami Beach,

FL 33162 U.S.A.

MADE IN THE USA

PRINCIPAL DISPLAY PANEL

NDC: 80513-383-22

Compare to the  active indredient in VICKS ®ZzzQuil ®NIGHTTIME SLEEP-AID*

NIGHT TIME SLEEP-AID

Diphenhydramine HCl 25 mg

220 CAPLETS

*This product is not manufactured or distributed by The The Procter & Gamble Company, owner of the registered trademark VICKS ®ZzzQuil ®NIGHTTIME SLEEP-AID

INGREDIENTS AND APPEARANCE

NIGHT TIME SLEEP-AID 
diphenhydramine hcl tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80513-383
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
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)
STEARIC ACID (UNII: 4ELV7Z65AP)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TRIACETIN (UNII: XHX3C3X673)
FD&C RED NO. 40 ALUMINUM LAKE (UNII: 6T47AS764T)
FD&C BLUE NO. 2 ALUMINUM LAKE (UNII: 4AQJ3LG584)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80513-383-22	220 in 1 BOTTLE; Type 0: Not a Combination Product	08/01/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M010	08/01/2024

Labeler - Advanced Rx LLC (042795108)