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Maximum Strength Nighttime Sleep-Aid

Medically reviewed on October 11, 2017

Dosage form: capsule, liquid filled
Ingredients: DIPHENHYDRAMINE HYDROCHLORIDE 50mg
Labeler: Healthlife of USA
NDC Code: 69517-117

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.

Maximum Strength Nighttime Sleep-Aid

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-Aid
Diphenhydramine 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

MAXIMUM STRENGTH NIGHTTIME SLEEP-AID 
diphenhydramine hcl capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69517-117
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 
POLYVINYL ACETATE PHTHALATE 
PROPYLENE GLYCOL 
SORBITOL 
TITANIUM DIOXIDE 
WATER 
Product Characteristics
ColorpurpleScoreno score
ShapeOVALSize13mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:69517-117-161 BOTTLE in 1 CARTON
116 CAPSULE, LIQUID FILLED in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33805/02/2017
Labeler - Healthlife of USA (079656178)
Establishment
NameAddressID/FEIOperations
Healthlife of USA079656178repack(69517-117)
Establishment
NameAddressID/FEIOperations
Elysium Pharmaceuticals Limited915664486manufacture(69517-117), pack(69517-117)

 
Healthlife of USA

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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