MAXIMUM STRENGTH NIGHTTIME SLEEP-AID- diphenhydramine hcl capsule, liquid filled

Maximum Strength Nighttime Sleep-Aid by

Drug Labeling and Warnings

Maximum Strength Nighttime Sleep-Aid by is a Otc medication manufactured, distributed, or labeled by Healthlife of USA, Elysium Pharmaceuticals Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts 

Maximum Strength Nighttime Sleep-Aid

Purpose

Nighttime Sleep-Aid

Active Ingredient (in each softgel) 

Diphenhydramine HCL 50mg 

Uses

• Relief of occasional sleeplessness

Warnins 

Do not use

• for children under 12 years of age 
• with any other product containing diphenhydramine, even one used on skin
• with other drugs that cause drowsiness such as antihistamine and nighttime cold/flu products

Ask a doctor before use if you have 

• a breathing problem such as asthma, emphysema or chronic bronchitis 
• glaucoma 
• trouble urinating due to an enlarged prostate gland 
• heart disease 

Ask your doctor or pharmacist before use if you are

• taking sedative or tranquilizers or any other sleep-aid.

When using this product

• drowsiness will occur
• avoid alcoholic beverages and other drugs that cause drowsiness
• alcohol, sedatives and tranquilizers may increase drowsiness
• be careful when driving a motor vehicle or operating machinery 

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 childern. 

Overdose warning: Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any sighs or symptoms.

Directions

• Do not take more than directed (see overdosage warning) 
• Adults and children 12 years and over: Take 1 softgel at bedtime if needed or as directed by a doctor
• Children under 12 years of age: Do not use

Other Information

• Store at 15°-30°C (59°-86°F)
• Read all product information before using 
• TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Inactive Ingredients

• FD&C Blue#1
• Gelatin
• Glycerin
• Polyethylene glycol
• Polyvinyl acetate phthalate
• Polyvinyl glycol
• Sorbitol
• Titanium Dioxide
• Water

Questions or Comments?

Call toll free 1-844-832-1138 Monday through Friday 9AM -5PM EST or www.healthlifeofusa.com

Maximum Strength Nighttime Sleep-AidDiphenhydramine HCL 50mg / Nighttime Sleep-Aid 16  Softgels

afe & Non-Habit Forming
Get to sleep Fast
Sleep Soundly
Wake Refreshed

Compare to Unisom® Sleepgels® active ingredients

Distributed by:

Healthlife of USA LLC
Rahway
NJ 07065
www.healthlifeofusa.com

INGREDIENTS AND APPEARANCE

MAXIMUM STRENGTH NIGHTTIME SLEEP-AID 
diphenhydramine hcl capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69517-117
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	50 mg

Inactive Ingredients
Ingredient Name	Strength
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)
POLYVINYL ACETATE PHTHALATE (UNII: 58QVG85GW3)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SORBITOL (UNII: 506T60A25R)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	purple	Score	no score
Shape	OVAL	Size	13mm
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69517-117-16	1 in 1 CARTON	05/02/2017
1		16 in 1 BOTTLE; 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	05/02/2017

Labeler - Healthlife of USA (079656178)

Establishment
Name	Address	ID/FEI	Business Operations
Healthlife of USA		079656178	repack(69517-117)

Establishment
Name	Address	ID/FEI	Business Operations
Elysium Pharmaceuticals Limited		915664486	manufacture(69517-117) , pack(69517-117)