Nytol Gelcap 50 Mg_export Only 63029-928

SPL v2

SPL

SPL Set ID fc3d981c-313c-49f6-b7ee-5524ee6ef056

Route

ORAL

Published

Effective Date 2024-01-19

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Diphenhydramine (50 mg)

Inactive Ingredients

Fd&c Blue No. 1 Aluminum Lake Gelatin Glycerin Polyethylene Glycol, Unspecified Sorbitan Sorbitol Water

Identifiers & Packaging

Pill Appearance

Imprint: N Shape: oval Color: blue Size: 1 mm Score: 1

Marketing Status

EXPORT ONLY Active Since 2012-06-01

Description

Drug Facts

Purpose

Diphenhydramine Hydrochloride 50 mg Nighttime sleep aid

Medication Information

Purpose

Diphenhydramine Hydrochloride 50 mg Nighttime sleep aid

Description

Drug Facts

Uses

● helps to reduce difficulty falling asleep

● relieves occasional sleeplessness

Section 42229-5

Drug Facts

Directions

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

Do Not Use

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

Questions?

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

Ask A Doctor Or

have

• a breathing problem such as emphysema or chronic bronchitis

• glaucoma
difficulty urinating
take sedatives or tranquilizers
are pregnant or breast-feeding

Other Information

Store between 15 & 30 °C

Inactive Ingredients

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

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

When Using This Product

avoid drinking alcohol

Stop Use and Ask A Doctor If

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

Keep Out of Reach of Children.

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

Structured Label Content

Uses

● helps to reduce difficulty falling asleep

● relieves occasional sleeplessness

Section 42229-5 (42229-5)

Drug Facts

Purpose

Diphenhydramine Hydrochloride 50 mg Nighttime sleep aid

Directions

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

Do Not Use (Do not use)

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

Questions?

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

Ask A Doctor Or (Ask a doctor or)

have

• a breathing problem such as emphysema or chronic bronchitis

• glaucoma
difficulty urinating
take sedatives or tranquilizers
are pregnant or breast-feeding

Other Information (Other information)

Store between 15 & 30 °C

Inactive Ingredients (Inactive ingredients)

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

Principal Display Panel (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

When Using This Product (When using this product)

avoid drinking alcohol

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

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

Keep Out of Reach of Children. (Keep out of reach of children.)

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

Advanced Ingredient Data

[{"name": "DIPHENHYDRAMINE", "unii": "8GTS82S83M", "classCode": "ACTIB", "strengthNumerator": "50", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "FD&C BLUE NO. 1 ALUMINUM LAKE", "unii": "J9EQA3S2JM", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GELATIN", "unii": "2G86QN327L", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYETHYLENE GLYCOL, UNSPECIFIED", "unii": "3WJQ0SDW1A", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SORBITAN", "unii": "6O92ICV9RU", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SORBITOL", "unii": "506T60A25R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "● helps to reduce difficulty falling asleep ● relieves occasional sleeplessness", "42229-5": "Drug Facts", "Purpose": "Diphenhydramine Hydrochloride 50 mg Nighttime sleep aid ", "Directions": "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", "Do not use": "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", "Questions?": "1-800-465-8811 www.nytol.ca", "Ask a doctor or": "have • a breathing problem such as emphysema or chronic bronchitis • glaucoma difficulty urinating take sedatives or tranquilizers are pregnant or breast-feeding", "Other information": "Store between 15 & 30 °C", "Inactive ingredients": "edible white ink, FD&C blue #1, gelatin, glycerin, polyethylene glycol, purified water, sorbitol sorbitan", "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", "When using this product": "avoid drinking alcohol", "Stop use and ask a doctor if": "sleeplessness continues for more than 2 weeks. Sleeplessness may be a symptom of a serious underlying medical illness.", "Keep out of reach of children.": "In case of overdose, call a poison control centre or get medical help right away."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:42.684505 · Updated: 2026-03-14T23:02:25.522673