SLEEP AID- diphenhydramine hcl 25 mg tablet

Sleep Aid by

Drug Labeling and Warnings

Sleep Aid by is a Otc medication manufactured, distributed, or labeled by Pioneer Life Sciences, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient (in each caplet)

Diphenhydramine HCl 25mg

Purpose

Night Time Sleep Aid

Uses:

for relief of occasional sleeplessness

Warnings:

Do not use:

■ in 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 use if you are:■taking sedatives or tranquilizers.

WHEN USING

When using this product:

■ avoid alcoholic drinks
■ drowsiness will occur 

■ do not drive a motorvehicle or operate machinery.

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

Overdose Warning:In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222).

DIRECTIONS

■ do not take more than directed(See overdose warning) 

■ adults and children 12 years and over: take 2 caplets at bedtime if needed or as directed by doctor

■ children under 12 years: do not use

OTHER INFORMATION

■each caplet contains: calcium 23.52 mg

■store between 15-30°C (59-86°F).

■Avoid high humidity.

■ Protect from light.

INACTIVE INGREDIENTS

Colloidal Silicon, Croscarmellose, Sodium, Dicalcium Phosphate, FD&C Blue#1, FD&C Blue#2, Lethicin, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Polyvinyl Alcohol , Titanium Dioxide, Talc.

QUESTIONS OR COMMENTS?

Call toll free 1-732-698-5070 Mon to Fri 9am – 5pm.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SLEEP AID 
diphenhydramine hcl 25 mg tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72090-020
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)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TALC (UNII: 7SEV7J4R1U)

Product Characteristics
Color	blue	Score	no score
Shape	CAPSULE	Size	11mm
Flavor		Imprint Code	S5
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72090-020-10	100 in 1 BOTTLE; Type 0: Not a Combination Product	06/29/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M010	06/29/2020

Labeler - Pioneer Life Sciences, LLC (014092742)