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Nighttime Sleep Aid by HealthLife of USA

Dosage form: tablet, coated
Ingredients: DIPHENHYDRAMINE HYDROCHLORIDE 25mg
Labeler: HealthLife of USA
NDC Code: 69517-110

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.

Drug Facts

Active ingredient (in each caplet)

Diphenhydramine HCl 25 mg

Purpose

Nighttime sleep-aid

Uses

provides relief of occasional sleeplessness

Warnings

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 antihistamines and nighttime cold/flu products

Ask a doctor before use if you have
  • a breathing problem such as emphysema or chronic bronchitis
  • trouble urinating due to an enlarged prostate gland
  • glaucoma
  • heart disease

Ask a 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
  • excitability may occur, especially in children
  • 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 children.

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 signs or symptoms.

Directions
  • do not take more than directed (see overdose warning)
  • adults and children 12 years of age and over: - take 2 caplets at bedtime if needed or as directed by a doctor
  • children under 12 years of age: do not use

Other Information
  • Each caplet contains: Calcium 23.52 mg
  • store at 25°C (77°F); excursions permitted between 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

Colloidal silicon dioxide, Croscarmellose sodium, Dicalcium phosphate, FD&C Blue #1, FD&C Blue #2, Magnesium stearate, Microcrystalline cellulose, Polyethylene glycol, Polyvinyl alcohol, Talc, Titanium dioxide

Questions or comments?

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

Principal Display Panel

Compare to Tylenol® Simply Sleep active ingredients*

* This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Simply Sleep®.

Diphenhydramine HCl Tablets, 25 mg

NIGHTTIME SLEEP AID 
diphenhydramine hcl 25 mg tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69517-110
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE 
CROSCARMELLOSE SODIUM 
ANHYDROUS DIBASIC CALCIUM PHOSPHATE 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
TITANIUM DIOXIDE 
POLYVINYL ALCOHOL 
POLYETHYLENE GLYCOLS 
TALC 
FD&C BLUE NO. 1 
FD&C BLUE NO. 2 
Product Characteristics
ColorblueScoreno score
ShapeCAPSULESize11mm
FlavorImprint CodeEC
Contains    
Packaging
#Item CodePackage Description
1NDC:69517-110-2525 POUCH in 1 BOX
12 TABLET, COATED in 1 POUCH
2NDC:69517-110-5050 POUCH in 1 BOX
22 TABLET, COATED in 1 POUCH
3NDC:69517-110-022 POUCH in 1 POUCH
32 TABLET, COATED in 1 POUCH
4NDC:69517-110-011000 BOTTLE in 1 BOTTLE
4NDC:69517-110-05500 BOTTLE in 1 BOTTLE
4NDC:69517-110-3030 CARTON in 1 BOTTLE
41 TABLET, COATED in 1 CARTON
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34106/01/2017
Labeler - HealthLife of USA (079656178)
Establishment
NameAddressID/FEIOperations
Elysium Pharmaceutical Ltd.915664486manufacture(69517-110)

 
HealthLife of USA

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Medically reviewed on Jun 5, 2017

Further information

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

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