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

Diphenhydramine HCI 25 mg

Good Sense Sleep-Aid Tablets


SLEEP AID  REGULAR STRENGTH
diphenhydramine hcl tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50804-252
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorBLUEScore2 pieces
ShapeROUNDSize10mm
FlavorImprint Code 10081008
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50804-252-162 in 1 CARTON02/28/201401/01/2020
18 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33802/28/201401/01/2020
Labeler - Good Sense (Geiss, Destin & Dunn, Inc.) (076059836)

Revised: 11/2018
 
Good Sense (Geiss, Destin & Dunn, Inc.)