NYTOL- diphenhydramine hcl capsule, gelatin coated

Nytol by

Drug Labeling and Warnings

Nytol by is a Otc medication manufactured, distributed, or labeled by Medtech Products Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Purpose

Diphenhydramine Hydrochloride 50 mg             Nighttime sleep aid

  

Uses/ Indications

● helps to reduce difficulty falling asleep

● relieves occasional sleeplessness

Warnings

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

Ask a doctor or pharmacist before use if you

• 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

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.

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

Other information

Store between 15 & 30 °C

Inactive ingredients

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

Questions?

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

PRINCIPAL DISPLAY PANEL

Extra Strength Ultra-fort

Nytol®/MD

QUICKGELS®

GÉLULES-RAPIDESMC

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

INGREDIENTS AND APPEARANCE

NYTOL 
diphenhydramine hcl capsule, gelatin coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63029-928
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	50 mg

Inactive Ingredients
Ingredient Name	Strength
FD&C BLUE NO. 1 ALUMINUM LAKE (UNII: J9EQA3S2JM)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
SORBITAN (UNII: 6O92ICV9RU)
SORBITOL (UNII: 506T60A25R)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	blue	Score	no score
Shape	OVAL	Size	1mm
Flavor		Imprint Code	N
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63029-928-16	2 in 1 CARTON	06/01/2012
1		8 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Export only		06/01/2012

Labeler - Medtech Products Inc. (122715688)