DG HEALTH MAXIMUM STRENGTH SLEEP AID- diphenhydramine hydrochloride capsule, liquid filled
Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)

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 50 mg

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 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.

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 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

Inactive Ingredients

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

Product Labeling

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

Maximum Strength

Sleep Aid

Diphenhydramine HCl 50 mg

*This product is not manufactured or distributed by Chattem, Inc., owner of the registered trademark Maximum Strength Unisom® SleepGels®.

Distributed by DOLGENCORP, LLC

100 mission ridge

Goodlettsville, TN 37072

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORAMTION

Container Label

Diphenhydramine HCl 50 mg

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:55910-230
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE)	DIPHENHYDRAMINE HYDROCHLORIDE	50 mg

Inactive Ingredients
Ingredient Name	Strength
FD&C BLUE NO. 1
GELATIN
GLYCERIN
POLYETHYLENE GLYCOLS
WATER
SORBITOL

Product Characteristics
Color	BLUE (BLUE)	Score	no score
Shape	OVAL (OVAL)	Size	13mm
Flavor		Imprint Code	P50;A99
Contains

Packaging
#	Item Code	Package Description
1	NDC:55910-230-99	1 in 1 BOX
1		40 in 1 BOTTLE
2	NDC:55910-230-32	1 in 1 BOX
2		32 in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part338	11/29/2012

Labeler - Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) (068331990)

Revised: 07/2013

Document Id: f77dc579-c2f6-40e2-9efe-54fa75b0ee17

Set id: 93060176-d958-4491-9816-376986409833

Version: 2

Effective Time: 20130703

Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)