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Nighttime Sleep Aid by We Care Distributor Inc

Medically reviewed on February 23, 2018

Dosage form: tablet
Ingredients: DIPHENHYDRAMINE HYDROCHLORIDE 25mg
Labeler: We Care Distributor Inc
NDC Code: 70005-014

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 tablet)

Diphenhydramine HCl 25 mg

Purpose

Nighttime sleep-aid

Uses

provides relief of occasional sleeplessness

Warnings

Do not use
  • with any other products containing diphenhydramine, even one used on skin
  • in children under 12 years of age

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

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers

When using this product
  • drowsiness may occur
  • avoid alcoholic drinks
  • do not drive a motor vehicle or operating a 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.

In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Directions
  • do not take more than directed
  • adults and children 12 years of age and over - take 2 tablets 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 25 mg
  • store at controlled room temperature 15°-30°C (59°-86°F)

  • avoid excessive heat and humidity

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: 1-800-705-WECARE (Mon-Fri 9am-5pm EST) or www.wecaredistributor.com

Principal Display Panel

NIGHTTIME SLEEP AID 
diphenhydramine hcl tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70005-014
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 GLYCOL 400 
TALC 
FD&C BLUE NO. 1 
FD&C BLUE NO. 2 
Product Characteristics
ColorblueScoreno score
ShapeCAPSULESize11mm
FlavorImprint CodeEC
Contains    
Packaging
#Item CodePackage Description
1NDC:70005-014-2525 POUCH in 1 BOX
14 TABLET in 1 POUCH
2NDC:70005-014-5050 POUCH in 1 BOX
24 TABLET in 1 POUCH
3NDC:70005-014-022 POUCH in 1 BOX
32 TABLET in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34102/04/2016
Labeler - We Care Distributor Inc (079832998)
Establishment
NameAddressID/FEIOperations
Elysium Pharmaceutical Ltd.915664486manufacture(70005-014)

 
We Care Distributor Inc

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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