Sleep Aid by Good Sense (Geiss, Destin & Dunn, Inc.) / P & L Development, LLC DRUG FACTS

Drug Details [pdf]

SLEEP AID REGULAR STRENGTH- diphenhydramine hcl tablet
Good Sense (Geiss, Destin & Dunn, Inc.)

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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DRUG FACTS

Active ingredient (in each tablet)

Diphenhydramine HCl 25 mg

Purpose

Nighttime sleep-aid

Use

helps reduce difficulty falling asleep

Warnings

Do not give to children under 12 years of age.

Do not use this product

with other products containing diphenhydramine, even one used on skin

Ask a doctor before use if you have

emphysema
chronic bronchitis
glaucoma
difficulty in urination due to an enlargement of the prostate gland

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers

When using this product

avoid alcoholic beverages.

stop use and ask a doctor if

sleeplessness persists for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness.

If pregnant or breast-feeding,

ask a health care professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

Adults and children 12 years and over: take 2 tablets at bedtime or as directed by a doctor. For best results, take recommended dose. This will provide approximately 6 to 8 hours of restful sleep.

Other information

each tablet contains: calcium 65 mg
store at controlled room temperature 15°-30°C (59°-86°F)
avoid excessive heat and humidity
**This product is not manufactured or distributed by Glaxosmithkline, owner of the registered trademark Sominex®

Inactive ingredients

croscarmellose sodium, dicalcium phosphate, FD&C Blue #1 aluminium lake, magnesium stearate, microcrystalline cellulose, silicon dioxide*, and stearic acid*

*Contains one or more of these ingredients.

Questions or Comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

**Compare to the active ingredient in Sominex® Original Formula

Regular Strength

Sleep-Aid

wake rested and refreshed

Diphenhydramine HCl 25 mg

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

THIS PRODUCT IS PACKAGED IN A CHILD RESISTANT AND TAMPER EVIDENT PACKAGE. USE ONLY IF BLISTERS ARE INTACT.

Product Label

Diphenhydramine HCl 25 mg

SLEEP AID REGULAR STRENGTH
diphenhydramine hcl tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50804-200
Route of Administration	ORAL

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

Ingredient Name	Strength
Inactive Ingredients
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
STEARIC ACID (UNII: 4ELV7Z65AP)
ALUMINUM OXIDE (UNII: LMI26O6933)

Product Characteristics
Color	BLUE	Score	2 pieces
Shape	ROUND	Size	10mm
Flavor		Imprint Code	1008;1008
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 50804-200-16	2 in 1 CARTON	08/03/2010	01/01/2020
1		8 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part336	08/03/2010	01/01/2020

Labeler - Good Sense (Geiss, Destin & Dunn, Inc.) (076059836)

Registrant - P & L Development, LLC (800014821)

Revised: 11/2018

Document Id: e313b65e-0160-44c0-985f-b42b8bae9379

Set id: acd20c0e-8ee5-42db-90fe-5ec43cc69a64

Version: 2

Effective Time: 20181120

Good Sense (Geiss, Destin & Dunn, Inc.)