NIGHTTIME SLEEP AID: Package Insert and Label Information

NIGHTTIME SLEEP AID- diphenhydramine hydrochloride capsule, liquid filled
Dolgencorp, Inc.

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

Uses

  • 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 persist 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.

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

Directions

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

Inactive ingredients

FD&C Blue#1, gelatin, glycerin, polyethylene glycol-400, propylene glycol, sorbitol, titanium dioxide, water

Questions or comments?

1-888-309-9030

PRINCIPAL DISPLAY PANEL

Compare to the active ingredient

in UNISOMĀ® SleepGelsĀ®*

Maximum Strength

NIGHTTIME

SLEEP-AID minis

DIPHENHYDRAMINE HCl 50 mg

NIGHTTIME SLEEP-AID

Wake Refreshed
Safe/Non-Habit Forming LIQUID FILLED

image description
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NIGHTTIME SLEEP AID
diphenhydramine hydrochloride capsule, liquid filled
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:55910-863
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE 50 mg
Inactive Ingredients
Ingredient Name Strength
FD&C BLUE NO. 1
FD&C RED NO. 40
GELATIN
GLYCERIN
POLYETHYLENE GLYCOL 400
PROPYLENE GLYCOL
SORBITOL
TITANIUM DIOXIDE
WATER
ALUMINUM SILICATE
POVIDONE
Product Characteristics
Color blue (OPAQUE) Score no score
Shape OVAL Size 9mm
Flavor Imprint Code 103
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:55910-863-32 1 BOTTLE in 1 CARTON contains a BOTTLE
1 32 CAPSULE, LIQUID FILLED in 1 BOTTLE This package is contained within the CARTON (55910-863-32)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part338 03/13/2020
Labeler — Dolgencorp, Inc. (068331990)

Revised: 11/2022 Dolgencorp, Inc.

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