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Sleep-Aid Nighttime by P & L Development, LLC

Medically reviewed on January 17, 2018

Dosage form: capsule, liquid filled
Ingredients: DIPHENHYDRAMINE HYDROCHLORIDE 25mg
Labeler: P & L Development, LLC
NDC Code: 59726-405

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 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

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

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.

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

Directions
  • take only one dose (2 softgels) per day (24 hours) 
  • swallow whole; do not crush, chew, or dissolve
  • adults & children 12 years and over: take 2 softgels at bedtime, if needed, or as directed by a doctor
  • children under 12 years of age: do not use

Other information
  • store between 20-25° C (68-77° F)
  • avoid excessive heat above 40° C (104° F) and high humidity
  • protect from light

Inactive ingredients

edible white ink, FD&C blue #1, FD&C red #40, gelatin, glycerin, polyethylene glycol 400, propylene glycol*, purified water, sorbitol, sorbitan

*may contain this ingredient

Questions or comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

nighttime sleep-aid

Diphenhydramine HCl 25 mg

nighttime sleep-aid

  • non habit-forming
  • not for treating cold or flu

See Warnings

softgels**

(**liquid-filled capsules)

†Compare to the active ingredient in ZZZQUIL®

This product is not manufactured or distributed by The Procter & Gamble Company. ZZZQUIL® is a registered trademark of The Procter & Gamble Company.

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

Distributed by: PL Developments,

200 Hicks Street,

Westbury, NY 11590

Package Label

WELLNESS BASICS Nighttime Sleep-Aid

SLEEP-AID  NIGHTTIME
diphenhydramine hydrochloride capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59726-405
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 
GELATIN 
GLYCERIN 
POLYETHYLENE GLYCOL 400 
WATER 
FD&C RED NO. 40 
SORBITOL 
SORBITAN 
PROPYLENE GLYCOL 
Product Characteristics
ColorPURPLEScoreno score
ShapeCAPSULESize15mm
FlavorImprint CodeA41;602
Contains    
Packaging
#Item CodePackage Description
1NDC:59726-405-4848 BLISTER PACK in 1 CARTON
11 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33812/31/2017
Labeler - P & L Development, LLC (800014821)

 
P & L Development, LLC

← See all Sleep-Aid Nighttime brands

Further information

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

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