Nytol

Manufacturer: Medtech Products Inc.
Effective date: 2024-01-19
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: full-release
Hydrated at: 2026-06-01 00:07:32

Label at a glance#

ProductNytol

Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE

Label structure9 sections

Indications and uses

● helps to reduce difficulty falling asleep ● relieves occasional sleeplessness

Dosage and administration

Adults and children 12 years and over: take 1 capsule at bedtime if needed, or as directed by a doctor if you feel drowsy in the morning, consult a doctor or pharmacist, as you may require a lower dosage (25 mg) do not take more than directed

Contacts and useful links#

PhoneLabel contact1-800-465-8811

Websitewww.nytol.ca

www.nytol.ca

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Purpose

OTC - PURPOSE SECTION

Diphenhydramine Hydrochloride 50 mg Nighttime sleep aid

Uses/ Indications

INDICATIONS & USAGE SECTION

● helps to reduce difficulty falling asleep

● relieves occasional sleeplessness

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

if you are elderly, as this drug may cause excitation rather than sedation
with any other product containing diphenhydramine, even one used on skin
in children under 12 years of age

Ask a doctor or pharmacist before use if you

OTC - ASK DOCTOR/PHARMACIST SECTION

have
• a breathing problem such as emphysema or chronic bronchitis
• glaucoma
difficulty urinating
take sedatives or tranquilizers
are pregnant or breast-feeding

When using this product

OTC - WHEN USING SECTION

avoid drinking alcohol

Stop use and ask a doctor if

OTC - STOP USE SECTION

sleeplessness continues for more than 2 weeks. Sleeplessness may be a symptom of a serious underlying medical illness.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, call a poison control centre or get medical help right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 12 years and over:

take 1 capsule at bedtime if needed, or as directed by a doctor

if you feel drowsy in the morning, consult a doctor or pharmacist, as you may require a lower dosage (25 mg)
do not take more than directed

Other information

OTHER SAFETY INFORMATION

Store between 15 & 30 °C

Inactive ingredients

INACTIVE INGREDIENT SECTION

edible white ink, FD&C blue #1, gelatin, glycerin, polyethylene glycol, purified water, sorbitol sorbitan

Questions?

OTC - QUESTIONS SECTION

1-800-465-8811 www.nytol.ca

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Extra Strength Ultra-fort

Nytol^® ^/ ^MD

QUICKGELS^®

GÉLULES-RAPIDES^MC

Extra Strength Ultra-fort

50 mg Diphenhydramine Hydrochloride Capsules USP

Capsules de chlorhydrate de diphenhydramine 50 mg USP

16 soft gels

gélules molles

DIN 02237169

PRINCIPAL DISPLAY PANEL Extra Strength Ultra-fort Nytol®/MD QUICKGELS® GÉLULES-RAPIDESMC Extra Strength Ultra-fort 50 mg Diphenhydramine Hydrochloride Capsules USP Capsules de c...

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1020477	diphenhydrAMINE HCl 50 MG Oral Capsule	PSN	2
1092419	Nytol 50 MG Oral Capsule	PSN	2
1092419	diphenhydramine hydrochloride 50 MG Oral Capsule [Nytol]	SBD	2
1020477	diphenhydramine hydrochloride 50 MG Oral Capsule	SCD	2
1020477	diphenhydramine HCl 50 MG Oral Capsule	SY	2
1092419	Nytol 50 MG Oral Capsule	SY	2

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
63029-928-16	2026-01-29	C162847	48780-1	49896155-afca-586f-e063-e6dba90add90	Nytol Gelcap 50 mg_Export only 63029-928

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
63029-928-16	Nytol	8 in 1 BLISTER PACK	CAPSULE, GELATIN COATED	8		2
63029-928-16	Nytol	2 in 1 CARTON	CAPSULE, GELATIN COATED	2		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63029-928	NYTOL (DIPHENHYDRAMINE HCL) CAPSULE, GELATIN COATED [MEDTECH PRODUCTS INC.]	2	2 package rows	20240118_fc3d981c-313c-49f6-b7ee-5524ee6ef056.zip

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

Nytol
diphenhydramine hcl
DIPHENHYDRAMINE HYDROCHLORIDE
DIPHENHYDRAMINE
FD&C BLUE NO. 1 ALUMINUM LAKE
GELATIN
GLYCERIN
POLYETHYLENE GLYCOL, UNSPECIFIED
SORBITAN
SORBITOL
WATER

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
63029-928	63029-928-16

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
DIPHENHYDRAMINE HYDROCHLORIDE	TC2D6JAD40	ACTIB
FD&C BLUE NO. 1 ALUMINUM LAKE	J9EQA3S2JM	IACT
GELATIN	2G86QN327L	IACT
GLYCERIN	PDC6A3C0OX	IACT
POLYETHYLENE GLYCOL, UNSPECIFIED	3WJQ0SDW1A	IACT
SORBITAN	6O92ICV9RU	IACT
SORBITOL	506T60A25R	IACT
WATER	059QF0KO0R	IACT

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
5d247606-d3d7-4750-838f-40e09b5567f3			fc3d981c-313c-49f6-b7ee-5524ee6ef056	2024-01-19	Warnings	Exact identifier spl id: 5d247606-d3d7-4750-838f-40e09b5567f3 spl set id: fc3d981c-313c-49f6-b7ee-5524ee6ef056

Reported adverse events (FAERS/openFDA)#

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