DG HEALTH MAXIMUM STRENGTH SLEEP AID - diphenhydramine hydrochloride capsule, liquid filled 
Dolgencorp, LLC

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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Active Ingredient (in each softgel)

Diphenhydramine HCl 50mg

Purpose

Nighttime sleep aid

Use

helps to 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 or pharmacist 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 now 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.

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 1 softgel at bedtime if needed or as
directed by a doctor

Other information

  • store at controlled room temperature 15°-30°C (59°-86°F)
  • do not use if imprinted safety seal under cap is broken or missing
  • *This product is not manufactured or distributed by Chattem, Inc., owner of the registered trademark Maximum Strength Unisom® SleepGels®.


KEEP OUTER CARTON FOR COMPLETE
WARNINGS AND PRODUCT INFORMATION

Inactive Ingredients

edible white ink, FDandC Blue #1, gelatin, glycerin, polyethylene glycol, purified water and sorbitol special.

Questions or comments?

Call toll free: 1-888-309-9030

Distributed by:
Dolgencorp, LLC
100 Mission Ridge
Goodlettsville, TN 37072

100% Quality Guaranteed

(888) 309-9030


Product Labeling

*Compare to the
active ingredient in
Maximum Strength
Unisom® SleepGels®

DG Health
Maximum Strength Nighttime Sleep Aid

Diphenhydramine HCl 50mg


40 softgels

Container Label

Nighttime Sleep Aid

DG HEALTH MAXIMUM STRENGTH SLEEP AID 
diphenhydramine hydrochloride capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55910-230
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE50 mg
Inactive Ingredients
Ingredient NameStrength
FD&C BLUE NO. 1 
GELATIN 
GLYCERIN 
POLYETHYLENE GLYCOLS 
WATER 
SORBITOL 
Product Characteristics
Colorblue (BLUE) Scoreno score
ShapeOVAL (OVAL) Size13mm
FlavorImprint Code P50;A99
Contains    
Packaging
#Item CodePackage Description
1NDC:55910-230-991 in 1 BOX
140 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33811/29/2012
Labeler - Dolgencorp, LLC (068331990)

Revised: 11/2012
Document Id: b94698ff-04af-4a0a-ab26-a0e822f56844
Set id: 93060176-d958-4491-9816-376986409833
Version: 1
Effective Time: 20121129
 
Dolgencorp, LLC