Sleep Aid by Good Sense (Geiss, Destin & Dunn, Inc.) Drug Facts

Sleep Aid by

Drug Labeling and Warnings

Sleep Aid by is a Otc medication manufactured, distributed, or labeled by Good Sense (Geiss, Destin & Dunn, Inc.). Drug facts, warnings, and ingredients follow.

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 to reduce 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 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 drinks.

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

Directions

• adults and children 12 years of age and over: take 2 tablets at bedtime if needed or as directed by a doctor

Other information

• each tablet contains: calcium 65 mg
• store at 15°-30°C (59°-86°F)

Inactive ingredients

croscarmellose sodium, dicalcium phosphate, FD&C blue #1 aluminium lake, magnesium stearate, microcrystalline cellulose

Questions or comments?

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

Principal Display Panel

Regular Strength

Sleep-Aid Tablets

Wake Rested and Refreshed

Diphenhydramine HCl, 25 mg

Tablets (25 mg Each)

*Compare to active ingredient in Sominex®

*This product is not manufactured or distributed by Prestige Brands, Inc., owner of the registered trademark Sominex®

Distributed by: Geiss, Destin & Dunn, Inc.

Peachtree City, GA 30269

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWN ANY SIGNS OF TAMPERING.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

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Product Label

Good Sense Sleep-Aid Tablets

SLEEP AID  REGULAR STRENGTH
diphenhydramine hcl tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50804-252
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
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
ALUMINUM OXIDE (UNII: LMI26O6933)

Product Characteristics
Color	BLUE	Score	2 pieces
Shape	ROUND	Size	10mm
Flavor		Imprint Code	10081008
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50804-252-16	2 in 1 CARTON	02/28/2014	01/01/2020
1		8 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part338	02/28/2014	01/01/2020

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

Revised: 11/2018

Document Id: 6a20bc3b-1180-4b1a-a633-caaece7e1cc8

34390-5

Set id: 3237e65a-7631-4b19-ab6f-9400803324c0

Version: 3

Effective Time: 20181121

 

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