Nighttime Sleep Aid

Manufacturer: Spirit Pharmaceuticals LLC
Effective date: 2024-12-13
Label type: HUMAN OTC DRUG LABEL
Version: 5
Source: full-release
Hydrated at: 2026-06-01 00:43:08

Label at a glance#

ProductNighttime Sleep Aid

Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE

Label structure10 sections

Indications and uses

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

Dosage and administration

take only one dose per day (24 hours) adults & children 12 years & over take 2 softgels at bedtime if needed or as directed by a doctor children under 12 years do not use

Storage and handling

• store at 20-25° C (68-77° F) • avoid excessive heat above 40° C (104° F) and high humidity • Protect from light

Contacts and useful links#

PhonePoison Help1-800-222-1222

PhoneLabel contact1-888-333-9792

Label contents#

Full prescribing information#

Active Ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine Hydrochloride 25 mg

Purpose

OTC - PURPOSE SECTION

Nighttime sleep-aid

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

OTC - DO NOT USE SECTION

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

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have
• a breathing problem such as emphysema or chronic bronchitis • glaucoma
• difficulty in urination due to enlargement of the prostate gland

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers

OTC - WHEN USING SECTION

When using this product • avoid alcoholic beverages

OTC - STOP USE SECTION

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.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

take only one dose per day (24 hours)

adults & children 12 years & over	take 2 softgels at bedtime if needed or as directed by a doctor
children under 12 years	do not use

Other information

STORAGE AND HANDLING SECTION

• store at 20-25° C (68-77° F) • avoid excessive heat above 40° C (104° F) and high humidity • Protect from light

Inactive ingredients

INACTIVE INGREDIENT SECTION

FD&C Blue#1, FD&C Red#40, gelatin, glycerin, polyethylene glycol, propylene glycol, purified water, sorbitol sorbitan solution, titanium dioxide

Questions or comments?

OTC - QUESTIONS SECTION

1-888-333-9792

SPL UNCLASSIFIED SECTION

Distributed By:
Spirit Pharmaceuticals, LLC
Ronkonkoma, NY 11779

Made in India

Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Sleep aid

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1049909	diphenhydrAMINE HCl 25 MG Oral Capsule	PSN	5
1049909	diphenhydramine hydrochloride 25 MG Oral Capsule	SCD	5

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
DIPHENHYDRAMINE Pharmacologic Class Indexing	3	Indexing - Pharmacologic Class	20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
0e2e0f88-b076-afe1-4bdd-32bca4375bec	Product name	3	20250127
3e48c9c4-918d-5d23-2f0b-d2398b06be54	Product name	1	20140508
865c72dd-0d94-daac-f728-ddd4ded2a79e	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68210-4195-2	Nighttime Sleep Aid	24 in 1 BLISTER PACK	CAPSULE, LIQUID FILLED	24		5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68210-4195	NIGHTTIME SLEEP AID (DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [SPIRIT PHARMACEUTICALS LLC]	5	Legacy NDC, 1 package rows	20241215_39f5b3bd-262d-4253-a4ee-8d286fbb475f.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 13 matching rows.

Nighttime Sleep Aid
Diphenhydramine Hydrochloride
FD&C BLUE NO. 1
FD&C RED NO. 40
GELATIN
GLYCERIN
POLYETHYLENE GLYCOL, UNSPECIFIED
PROPYLENE GLYCOL
WATER
SORBITOL
SORBITAN
TITANIUM DIOXIDE
DIPHENHYDRAMINE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
68210-4195	68210-4195-2

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
FD&C BLUE NO. 1	H3R47K3TBD	IACT
FD&C RED NO. 40	WZB9127XOA	IACT
GELATIN	2G86QN327L	IACT
GLYCERIN	PDC6A3C0OX	IACT
POLYETHYLENE GLYCOL, UNSPECIFIED	3WJQ0SDW1A	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
WATER	059QF0KO0R	IACT
SORBITOL	506T60A25R	IACT
SORBITAN	6O92ICV9RU	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
DIPHENHYDRAMINE HYDROCHLORIDE	TC2D6JAD40	ACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
29299135-c2e8-f499-e063-6294a90aff99			39f5b3bd-262d-4253-a4ee-8d286fbb475f	2024-12-13	Warnings	Exact identifier spl id: 29299135-c2e8-f499-e063-6294a90aff99 spl set id: 39f5b3bd-262d-4253-a4ee-8d286fbb475f

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.