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Sleep Aid Maximum Strength by P & L Development, LLC

Dosage form: capsule
Ingredients: DIPHENHYDRAMINE HYDROCHLORIDE 50mg
Labeler: P & L Development, LLC
NDC Code: 59726-236

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 50 mg

Purpose

Nighttime sleep-aid

Purpose

Nighttime sleep-aid 

Use

for 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

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.

When using this product

avoid alcoholic drinks.

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.

Directions
  • adults and children 12 years of age and over: 1 softgel (50 mg) at bedtime if needed, or as directed by a doctor

Other information
  • store at 15°-30°C (59°-86°F)

Inactive ingredients

edible white ink, FD&C blue #1, gelatin, glycerin, light mineral oil*, polyethylene 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

Compare to the active ingredient in Unisom® SleepGels®†

Maximum Strength

Nighttime Sleep-Aid

Diphenhydramine HCl 50 mg

safe, non-habit forming

  • Fall Asleep Fast 
  • Sleep Soundly 
  • Wake up Refreshed

SOFTGELS Liquid Filled

One Softgel Per Dose

†This product is not manufactured or distributed by Chattem, Inc., owner of the registered trademark Unisom® SleepGels®.

Distributed by:

PL Developments

200 Hicks Street

Westbury, NY 11590

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

Package Label

ReadyinCase Nighttime sleep-aid maximum strength

SLEEP AID  MAXIMUM STRENGTH
diphenhydramine hcl capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59726-236
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 
LIGHT MINERAL OIL 
POLYETHYLENE GLYCOLS 
WATER 
SORBITAN 
SORBITOL 
Product Characteristics
ColorBLUEScoreno score
ShapeCAPSULESize13mm
FlavorImprint CodeP50;A99;S90
Contains    
Packaging
#Item CodePackage Description
1NDC:59726-236-081 BLISTER PACK in 1 CARTON
18 CAPSULE in 1 BLISTER PACK
2NDC:59726-236-321 BOTTLE, PLASTIC in 1 BOX
232 CAPSULE in 1 BOTTLE, PLASTIC
3NDC:59726-236-24240 CAPSULE in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34102/01/2014
Labeler - P & L Development, LLC (800014821)

 
P & L Development, LLC

← See all Sleep Aid Maximum Strength brands

Medically reviewed on Jun 4, 2018

Further information

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

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