Skip to Content

← See all Night Time Sleep Aid brands

Night Time Sleep Aid by PuraCap Pharmaceutical LLC

Medically reviewed on Apr 23, 2018

Dosage form: capsule, liquid filled
Ingredients: DIPHENHYDRAMINE HYDROCHLORIDE 25mg
Labeler: PuraCap Pharmaceutical LLC
NDC Code: 51013-129

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.

Night Time Sleep Aid

Drug Facts

Active ingredient (in each softgel)

Diphenhydramine HCl 25 mg

Purpose

Nighttime sleep-aid

Uses
  • for the relief of occasional sleeplessness
  • reduces time to fall asleep if you have difficulty falling asleep

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 asthma, emphysema, or chronic bronchitis
  • glaucoma
  • difficulty in urination due to enlargement of the prostate gland
  • heart disease

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers or any other sleep aid

When using this product
  •  avoid alcoholic beverages and other drugs that cause drowsiness
  •  drowsiness will occur
  •  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 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 right away.

Directions
  • take only one dose per day (24 hours) - see Overdose warning
 adults and children 12 years and over ONE dose = TWO 25 mg softgels (50 mg) at bed time if needed or as directed by a doctor

Other Information
  • store at 15-30° C (59-86° F)
  • avoid excessive heat above 40° C (104° F) and high humidity
  • protect from light

Inactive ingredients

FD&C blue #1, FD&C red #40, gelatin, glycerin, polyethylene glycol, purified water, sorbitol special, and white edible ink

Questions or comments?

Call toll free 1-888-309-9030

PRINCIPAL DISPLAY PANEL

Night Time Sleep-Aid 

Diphenhydramine HCl, 25 mg

Compare to the active ingredient of Vicks® ZzzQuil® LiquiCaps® *

12 Softgels

NDC 51013-129-02

* This product is not manufactured or distributed by Procter & Gamble, owner of the registered trademark Vicks® ZzzQuil® LiquiCaps®.

NIGHT TIME SLEEP AID 
diphenhydramine hydrochloride capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51013-129
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
FD&C BLUE NO. 1 
FD&C RED NO. 40 
GELATIN 
GLYCERIN 
POLYETHYLENE GLYCOLS 
WATER 
SORBITOL 
Product Characteristics
ColorpurpleScoreno score
Shapecapsule (oblong) Size14mm
FlavorImprint CodePC11
Contains    
Packaging
#Item CodePackage Description
1NDC:51013-129-021 BLISTER PACK in 1 CARTON
112 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33805/05/2016
Labeler - PuraCap Pharmaceutical LLC (962106329)
Establishment
NameAddressID/FEIOperations
Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd421293287manufacture(51013-129), analysis(51013-129)

 
PuraCap Pharmaceutical LLC

← See all Night Time Sleep Aid brands

Further information

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

Hide